ABSORBABLE GELATIN

Description of Event or Problem

EVENT VERBATIM [PREFERRED TERM] TRANSCATHETER ARTERIAL EMBOLIZATION (TAE) USING IODIZED OIL AND GELATIN SPONGE PARTICLES [OFF LABEL USE], TRANSCATHETER ARTERIAL EMBOLIZATION (TAE) USING IODIZED OIL AND GELATIN SPONGE PARTICLES [DEVICE USE ISSUE], LOCAL RECURRENCE OCCURRED IN 2 CASES [DISEASE RECURRENCE]. NARRATIVE: THIS IS A LITERATURE REPORT FOR THE FOLLOWING LITERATURE SOURCE(S): "IMPLICATIONS OF SELECTIVE TRANSCATHETER ARTERIAL EMBOLIZATION PRIOR TO CRYOABLATION", CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY, 2025; VOL:48(4 SUPPLE), PGS: S1391, DOI:10.1007/S00270- 025-04245-X. AN ELDERLY PATIENT RECEIVED ABSORBABLE GELATIN (ABSORBABLE GELATIN), FOR THERAPEUTIC EMBOLISATION. THE PATIENT'S RELEVANT MEDICAL HISTORY WAS NOT REPORTED. CONCOMITANT MEDICATION(S) INCLUDED: IODIZED OIL TAKEN FOR THERAPEUTIC EMBOLISATION. THE PATIENT ALSO TOOK OTHER CONCOMITANT THERAPY (CRYOABLATION). THE FOLLOWING INFORMATION WAS REPORTED: OFF LABEL USE (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), DEVICE USE ISSUE (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "UNKNOWN" AND ALL DESCRIBED AS "TRANSCATHETER ARTERIAL EMBOLIZATION (TAE) USING IODIZED OIL AND GELATIN SPONGE PARTICLES"; DISEASE RECURRENCE (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "UNKNOWN", DESCRIBED AS "LOCAL RECURRENCE OCCURRED IN 2 CASES". THE LITERATURE REPORTED: CRYOABLATION IS USUALLY PERFORMED UNDER COMPUTED TOMOGRAPHY (CT) OR MAGNETIC RESONANCE IMAGING (MRI) GUIDANCE. IT IS MORE DIFFICULT TO DETERMINE TUMOR MARGINS AND ICE BALLS WITH CT THAN MRI. FURTHERMORE, CRYOABLATION CARRIES A RISK OF BLEEDING. TRANSCATHETER ARTERIAL EMBOLIZATION (TAE) USING IODIZED OIL AND GELATIN SPONGE PARTICLES (GS) CAN VISUALIZE TUMORS AND MAY PREVENT BLEEDING. THIS STUDY AIMED TO EVALUATE THE IMPLICATIONS OF SELECTIVE TAE PRIOR TO CRYOABLATION. ALL TAES WERE PERFORMED ONE DAY BEFORE CRYOABLATION WITH IODIZED OIL AND GS. CRYOABLATION WAS PERFORMED BY VISUAL ICE USING ICE SPHERE OR ICE ROD UNDER CT GUIDANCE. EVALUATION PATIENTS WHO UNDERWENT TAE PRIOR TO CRYOABLATION IN THE INSTITUTIONS FROM (B)(6) 2020 TO (B)(6) 2024 WERE INVESTIGATED. BLEEDING AND RENAL FUNCTION WERE EVALUATED AS INDICATORS OF SAFETY, AND LOCAL RECURRENCE WAS EVALUATED FOR EFFECTIVENESS. FROM (B)(6) 2020 TO (B)(6) 2024, 34 PATIENTS UNDERWENT TAE WITH CRYOABLATION. PATIENTS' CHARACTERISTICS WERE AS FOLLOWS: FEMALE/MALE, 8/26; MEDIAN AGE, 77.5 (34-91) YEARS; LEFT/RIGHT, 18/16; MEAN EGFR, 57.8 ML/MIN/1.73M2; MEAN PLATELET COUNT 19.7X10 4/MM3; AND MEAN PTINR, 1.04. HEMATOMAS OCCURRED IN 4 CASES, BUT NO ADDITIONAL PROCEDURES OR BLOOD TRANSFUSIONS WERE REQUIRED. DURING A MEAN OBSERVATION PERIOD OF 249 DAYS, LOCAL RECURRENCE OCCURRED IN 2 CASES (AFTER 139 AND 428 DAYS), AND RECURRENCE-FREE SURVIVAL WAS NOT REACHED. THREE TO FOUR WEEKS AFTER TAE, THE EGFR DECREASED AN AVERAGE OF 7.4%, BUT NO CASES REQUIRED DIALYSIS. IN CONCLUSION, TAE PRIOR TO CRYOABLATION MAY PREVENT BLEEDING AND REDUCE LOCAL RECURRENCE, WITH LITTLE EFFECT ON RENAL FUNCTION.THE PATIENT UNDERWENT THE FOLLOWING LABORATORY TESTS AND PROCEDURES: GLOMERULAR FILTRATION RATE: UNKNOWN RESULTS, NOTES: ML/MIN/1.73M2; DECREASED; PLATELET COUNT: UNKNOWN RESULTS, NOTES: X10 4/MM3; PROTHROMBIN TIME: UNKNOWN RESULTS. THE ACTION TAKEN FOR ABSORBABLE GELATIN WAS UNKNOWN. CAUSALITY FOR "TRANSCATHETER ARTERIAL EMBOLIZATION (TAE) USING IODIZED OIL AND GELATIN SPONGE PARTICLES" AND "LOCAL RECURRENCE OCCURRED IN 2 CASES" WAS DETERMINED ASSOCIATED TO ABSORBABLE GELATIN (MALFUNCTION)., COMMENT: BASED ON THE AVAILABLE INFORMATION, A CONTRIBUTORY ROLE OF THE SUSPECT PRODUCT GELFOAM TO THE REPORTED EVENT DISEASE RECURRENCE CANNOT BE EXCLUDED. IT WAS REPORTED THAT "TRANSCATHETER ARTERIAL EMBOLIZATION (TAE) USING IODIZED OIL AND GELATIN SPONGE PARTICLES" AND "LOCAL RECURRENCE OCCURRED IN 2 CASES". CASE WILL BE REASSESSED UPON RECEIPT OF ADDITIONAL INFORMATION. THE IMPACT OF THIS REPORT ON THE BENEFIT/RISK PROFILE OF THE PFIZER PRODUCT IS EVALUATED AS PART OF PFIZER PROCEDURES FOR SAFETY EVALUATION, INCLUDING THE REVIEW AND ANALYSIS OF AGGREGATE DATA FOR ADVERSE EVENTS. ANY SAFETY CONCERN IDENTIFIED AS PART OF THIS REVIEW, AS WELL AS ANY APPROPRIATE ACTION IN RESPONSE, WILL BE PROMPTLY NOTIFIED TO REGULATORY AUTHORITIES, ETHICS COMMITTEES AND INVESTIGATORS, AS APPROPRIATE.

Additional Manufacturer Narrative

INVESTIGATION SUMMARY AND CONCLUSION: THE COMPLAINT FOR 'ADVERSE EVENT MD/MDCP' FOR AN UNKNOWN BATCH OF GELFOAM ABSORBABLE MATERIAL WAS INVESTIGATED. THE INVESTIGATION INCLUDED REVIEWING APRRS FOR THE PRODUCT AND A MEDICAL DEVICE TREND REVIEW. THE FINAL SCOPE WAS DETERMINED TO BE ALL BATCHES OF GELFOAM MANUFACTURED BY PFIZER KALAMAZOO WITHIN THE 36 MONTHS (THE EXPIRY INTERVAL OF THE PRODUCT) PRIOR TO THE RECEIPT DATE OF THE COMPLAINT. A COMPLAINT SAMPLE WAS NOT RETURNED. NO RELATED QUALITY ISSUES WERE IDENTIFIED DURING THE INVESTIGATION. NO ROOT CAUSE OR CAPA WERE IDENTIFIED AS THE COMPLAINT WAS NOT CONFIRMED. NO RELATED QUALITY DEFECTS WERE IDENTIFIED THROUGH INVESTIGATION. THERE IS NO IMPACT ON MEDICAL DEVICE QUALITY, REGULATORY, VALIDATION, OR STABILITY. THE ONLY INFORMATION REPORTED IN THIS COMPLAINT IS THAT THE TRANSCATHETER ARTERIAL EMBOLIZATION (TAE) USING IODIZED OIL AND GELATIN SPONGE PARTICLES" AND "LOCAL RECURRENCE OCCURRED IN 2 CASES". THERE IS INSUFFICIENT INFORMATION TO INVESTIGATION THIS COMPLAINT. THUS, NO ADDITIONAL INVESTIGATION IS NECESSARY. THIS RECORD SHOULD BE CANCELLED.

Description of Event or Problem

EVENT [PREFERRED TERM] TRANSCATHETER ARTERIAL EMBOLIZATION (TAE) USING IODIZED OIL AND GELATIN SPONGE PARTICLES [OFF LABEL USE], TRANSCATHETER ARTERIAL EMBOLIZATION (TAE) USING IODIZED OIL AND GELATIN SPONGE PARTICLES [DEVICE USE ISSUE], LOCAL RECURRENCE OCCURRED IN 2 CASES [DISEASE RECURRENCE], , NARRATIVE: THIS IS A LITERATURE REPORT FROM PRODUCT QUALITY GROUP FOR THE FOLLOWING LITERATURE SOURCE(S): "IMPLICATIONS OF SELECTIVE TRANSCATHETER ARTERIAL EMBOLIZATION PRIOR TO CRYOABLATION", CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY, 2025; VOL:48(4 SUPPLE), PGS:S1391, DOI:10.1007/S00270-025-04245-X. AN ELDERLY PATIENT RECEIVED ABSORBABLE GELATIN (ABSORBABLE GELATIN), FOR THERAPEUTIC EMBOLISATION. THE PATIENT'S RELEVANT MEDICAL HISTORY WAS NOT REPORTED. CONCOMITANT MEDICATION(S) INCLUDED: IODIZED OIL TAKEN FOR THERAPEUTIC EMBOLISATION. THE PATIENT ALSO TOOK OTHER CONCOMITANT THERAPY. THE FOLLOWING INFORMATION WAS REPORTED: OFF LABEL USE (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), DEVICE USE ISSUE (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "UNKNOWN" AND ALL DESCRIBED AS "TRANSCATHETER ARTERIAL EMBOLIZATION (TAE) USING IODIZED OIL AND GELATIN SPONGE PARTICLES"; DISEASE RECURRENCE (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "UNKNOWN", DESCRIBED AS "LOCAL RECURRENCE OCCURRED IN 2 CASES". THE PATIENT UNDERWENT THE FOLLOWING LABORATORY TESTS AND PROCEDURES: GLOMERULAR FILTRATION RATE: UNKNOWN RESULTS, NOTES: ML/MIN/1.73M2; DECREASED; PLATELET COUNT: UNKNOWN RESULTS, NOTES: X10 4/MM3; PROTHROMBIN TIME: UNKNOWN RESULTS. THE ACTION TAKEN FOR ABSORBABLE GELATIN WAS UNKNOWN. CLINICAL COURSE: CRYOABLATION IS USUALLY PERFORMED UNDER COMPUTED TOMOGRAPHY (CT) OR MAGNETIC RESONANCE IMAGING (MRI) GUIDANCE. IT IS MORE DIFFICULT TO DETERMINE TUMOR MARGINS AND ICE BALLS WITH CT THAN MRI. FURTHERMORE, CRYOABLATION CARRIES A RISK OF BLEEDING. TRANSCATHETER ARTERIAL EMBOLIZATION (TAE) USING IODIZED OIL AND GELATIN SPONGE PARTICLES (GS) CAN VISUALIZE TUMORS AND MAY PREVENT BLEEDING. THIS STUDY AIMED TO EVALUATE THE IMPLICATIONS OF SELECTIVE TAE PRIOR TO CRYOABLATION. ALL TAES WERE PERFORMED ONE DAY BEFORE CRYOABLATION WITH IODIZED OIL AND GS. CRYOABLATION WAS PERFORMED BY VISUAL ICE USING ICE SPHERE OR ICE ROD UNDER CT GUIDANCE. EVALUATION PATIENTS WHO UNDERWENT TAE PRIOR TO CRYOABLATION IN THE INSTITUTIONS FROM APRIL 2020 TO DECEMBER 2024 WERE INVESTIGATED. BLEEDING AND RENAL FUNCTION WERE EVALUATED AS INDICATORS OF SAFETY, AND LOCAL RECURRENCE WAS EVALUATED FOR EFFECTIVENESS. FROM APRIL 2020 TO DECEMBER 2024, 34 PATIENTS UNDERWENT TAE WITH CRYOABLATION. PATIENTS' CHARACTERISTICS WERE AS FOLLOWS: FEMALE/MALE, 8/26; MEDIAN AGE, 77.5 (34-91) YEARS; LEFT/RIGHT, 18/16; MEAN EGFR, 57.8 ML/MIN/1.73M2; MEAN PLATELET COUNT 19.7X10 4/MM3; AND MEAN PT-INR, 1.04. LOCAL RECURRENCE OCCURRED IN 2 CASES (AFTER 139 AND 428 DAYS), AND RECURRENCE-FREE SURVIVAL WAS NOT REACHED. THREE TO FOUR WEEKS AFTER TAE, THE EGFR DECREASED AN AVERAGE OF 7.4%, BUT NO CASES REQUIRED DIALYSIS. IN CONCLUSION, TAE PRIOR TO CRYOABLATION MAY PREVENT BLEEDING AND REDUCE LOCAL RECURRENCE, WITH LITTLE EFFECT ON RENAL FUNCTION. CASE COMMENT: THIS IS REPORTABLE FOR THE US DUE TO A SERIOUS INJURY THAT NECESSITATES MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE OR FUNCTION. THIS IS ALSO A REPORTABLE MALFUNCTION. THIS EVENT IS REPORTABLE FOR ROW AS AN ANTICIPATED SERIOUS DETERIORATION IN STATE OF HEALTH OF A PATIENT. CAUSALITY FOR "TRANSCATHETER ARTERIAL EMBOLIZATION (TAE) USING IODIZED OIL AND GELATIN SPONGE PARTICLES" AND "LOCAL RECURRENCE OCCURRED IN 2 CASES" WAS DETERMINED ASSOCIATED TO ABSORBABLE GELATIN (MALFUNCTION). PRODUCT QUALITY GROUP PROVIDED INVESTIGATIONAL RESULTS ON 24FEB2026 FOR ABSORBABLE GELATIN: INVESTIGATION SUMMARY AND CONCLUSION: THE COMPLAINT FOR 'ADVERSE EVENT MD/MDCP' FOR AN UNKNOWN BATCH OF GELFOAM ABSORBABLE MATERIAL WAS INVESTIGATED. THE INVESTIGATION INCLUDED REVIEWING APRRS FOR THE PRODUCT AND A MEDICAL DEVICE TREND REVIEW. THE FINAL SCOPE WAS DETERMINED TO BE ALL BATCHES OF GELFOAM MANUFACTURED BY PFIZER KALAMAZOO WITHIN THE 36 MONTHS (THE EXPIRY INTERVAL OF THE PRODUCT) PRIOR TO THE RECEIPT DATE OF THE COMPLAINT. A COMPLAINT SAMPLE WAS NOT RETURNED. NO RELATED QUALITY ISSUES WERE IDENTIFIED DURING THE INVESTIGATION. NO ROOT CAUSE OR CAPA WERE IDENTIFIED AS THE COMPLAINT WAS NOT CONFIRMED. NO RELATED QUALITY DEFECTS WERE IDENTIFIED THROUGH INVESTIGATION. THERE IS NO IMPACT ON MEDICAL DEVICE QUALITY, REGULATORY, VALIDATION, OR STABILITY. THE ONLY INFORMATION REPORTED IN THIS COMPLAINT IS THAT THE TRANSCATHETER ARTERIAL EMBOLIZATION (TAE) USING IODIZED OIL AND GELATIN SPONGE PARTICLES" AND "LOCAL RECURRENCE OCCURRED IN 2 CASES". THERE IS INSUFFICIENT INFORMATION TO INVESTIGATION THIS COMPLAINT. THUS, NO ADDITIONAL INVESTIGATION IS NECESSARY. THIS RECORD SHOULD BE CANCELLED. FOLLOW-UP (07JAN2026): THIS IS A LITERATURE REPORT FOR THE FOLLOWING LITERATURE SOURCE: "IMPLICATIONS OF SELECTIVE TRANSCATHETER ARTERIAL EMBOLIZATION PRIOR TO CRYOABLATION", CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY, 2025; VOL:48(4 SUPPLE), PGS: S1391, DOI:10.1007/S00270-025-04245-X. THIS IS A FOLLOW-UP REPORT BASED ON THE RECEIPT OF THE PUBLICATION; THE CASE HAS BEEN UPDATED TO INCLUDE ADDITIONAL INFORMATION IDENTIFIED IN THE PUBLICATION. UPDATED INFORMATION: REPORTER DEPARTMENT. FOLLOW-UP (24FEB2026): THIS IS A FOLLOW-UP REPORT FROM PFIZER PRODUCT QUALITY GROUP PROVIDING INVESTIGATION RESULTS., COMMENT: BASED ON THE AVAILABLE INFORMATION, A CONTRIBUTORY ROLE OF THE SUSPECT PRODUCT GELFOAM TO THE REPORTED EVENT DISEASE RECURRENCE CANNOT BE EXCLUDED. IT WAS REPORTED THAT "TRANSCATHETER ARTERIAL EMBOLIZATION (TAE) USING IODIZED OIL AND GELATIN SPONGE PARTICLES" AND "LOCAL RECURRENCE OCCURRED IN 2 CASES" . CASE WILL BE REASSESSED UPON RECEIPT OF ADDITIONAL INFORMATION. THE IMPACT OF THIS REPORT ON THE BENEFIT/RISK PROFILE OF THE PFIZER PRODUCT IS EVALUATED AS PART OF PFIZER PROCEDURES FOR SAFETY EVALUATION, INCLUDING THE REVIEW AND ANALYSIS OF AGGREGATE DATA FOR ADVERSE EVENTS. ANY SAFETY CONCERN IDENTIFIED AS PART OF THIS REVIEW, AS WELL AS ANY APPROPRIATE ACTION IN RESPONSE, WILL BE PROMPTLY NOTIFIED TO REGULATORY AUTHORITIES, ETHICS COMMITTEES AND INVESTIGATORS, AS APPROPRIATE.

Description of Event or Problem

EVENT VERBATIM [PREFERRED TERM] TRANSCATHETER ARTERIAL EMBOLIZATION (TAE) USING IODIZED OIL AND GELATIN SPONGE PARTICLES [OFF LABEL USE], TRANSCATHETER ARTERIAL EMBOLIZATION (TAE) USING IODIZED OIL AND GELATIN SPONGE PARTICLES [DEVICE USE ISSUE], LOCAL RECURRENCE OCCURRED IN 2 CASES [DISEASE RECURRENCE] NARRATIVE: THIS IS A LITERATURE REPORT FOR THE FOLLOWING LITERATURE SOURCE: "IMPLICATIONS OF SELECTIVE TRANSCATHETER ARTERIAL EMBOLIZATION PRIOR TO CRYOABLATION", CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY, 2025; VOL:48(4 SUPPLE), PGS:S1391, DOI:10.1007/S00270-025-04245-X. AN ELDERLY PATIENT RECEIVED ABSORBABLE GELATIN (ABSORBABLE GELATIN), FOR THERAPEUTIC EMBOLISATION. THE PATIENT'S RELEVANT MEDICAL HISTORY WAS NOT REPORTED. CONCOMITANT MEDICATION(S) INCLUDED: IODIZED OIL TAKEN FOR THERAPEUTIC EMBOLISATION. THE PATIENT ALSO TOOK OTHER CONCOMITANT THERAPY. THE FOLLOWING INFORMATION WAS REPORTED: OFF LABEL USE (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), DEVICE USE ISSUE (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "UNKNOWN" AND ALL DESCRIBED AS "TRANSCATHETER ARTERIAL EMBOLIZATION (TAE) USING IODIZED OIL AND GELATIN SPONGE PARTICLES"; DISEASE RECURRENCE (INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "UNKNOWN", DESCRIBED AS "LOCAL RECURRENCE OCCURRED IN 2 CASES". THE ACTION TAKEN FOR ABSORBABLE GELATIN WAS UNKNOWN. CLINICAL COURSE: CRYOABLATION IS USUALLY PERFORMED UNDER COMPUTED TOMOGRAPHY (CT) OR MAGNETIC RESONANCE IMAGING (MRI) GUIDANCE. IT IS MORE DIFFICULT TO DETERMINE TUMOR MARGINS AND ICE BALLS WITH CT THAN MRI. FURTHERMORE, CRYOABLATION CARRIES A RISK OF BLEEDING. TRANSCATHETER ARTERIAL EMBOLIZATION (TAE) USING IODIZED OIL AND GELATIN SPONGE PARTICLES (GS) CAN VISUALIZE TUMORS AND MAY PREVENT BLEEDING. THIS STUDY AIMED TO EVALUATE THE IMPLICATIONS OF SELECTIVE TAE PRIOR TO CRYOABLATION. ALL TAES WERE PERFORMED ONE DAY BEFORE CRYOABLATION WITH IODIZED OIL AND GS. CRYOABLATION WAS PERFORMED BY VISUAL ICE USING ICE SPHERE OR ICE ROD UNDER CT GUIDANCE. EVALUATION PATIENTS WHO UNDERWENT TAE PRIOR TO CRYOABLATION IN THE INSTITUTIONS FROM APRIL 2020 TO DECEMBER 2024 WERE INVESTIGATED. BLEEDING AND RENAL FUNCTION WERE EVALUATED AS INDICATORS OF SAFETY, AND LOCAL RECURRENCE WAS EVALUATED FOR EFFECTIVENESS. FROM APRIL 2020 TO DECEMBER 2024, 34 PATIENTS UNDERWENT TAE WITH CRYOABLATION. PATIENTS' CHARACTERISTICS WERE AS FOLLOWS: FEMALE/MALE, 8/26; MEDIAN AGE, 77.5 (34-91) YEARS; LEFT/RIGHT, 18/16; MEAN EGFR, 57.8 ML/MIN/1.73M2; MEAN PLATELET COUNT 19.7X10 4/MM3; AND MEAN PT-INR, 1.04. LOCAL RECURRENCE OCCURRED IN 2 CASES (AFTER 139 AND 428 DAYS), AND RECURRENCE-FREE SURVIVAL WAS NOT REACHED. THREE TO FOUR WEEKS AFTER TAE, THE EGFR DECREASED AN AVERAGE OF 7.4%, BUT NO CASES REQUIRED DIALYSIS. IN CONCLUSION, TAE PRIOR TO CRYOABLATION MAY PREVENT BLEEDING AND REDUCE LOCAL RECURRENCE, WITH LITTLE EFFECT ON RENAL FUNCTION. CAUSALITY FOR "TRANSCATHETER ARTERIAL EMBOLIZATION (TAE) USING IODIZED OIL AND GELATIN SPONGE PARTICLES" AND "LOCAL RECURRENCE OCCURRED IN 2 CASES" WAS DETERMINED ASSOCIATED TO ABSORBABLE GELATIN (MALFUNCTION). FOLLOW-UP (07JAN2026): THIS IS A LITERATURE REPORT FOR THE FOLLOWING LITERATURE SOURCE: "IMPLICATIONS OF SELECTIVE TRANSCATHETER ARTERIAL EMBOLIZATION PRIOR TO CRYOABLATION", CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY, 2025; VOL:48(4 SUPPLE), PGS: S1391, DOI:10.1007/S00270-025-04245-X. THIS IS A FOLLOW-UP REPORT BASED ON THE RECEIPT OF THE PUBLICATION; THE CASE HAS BEEN UPDATED TO INCLUDE ADDITIONAL INFORMATION IDENTIFIED IN THE PUBLICATION. UPDATED INFORMATION: REPORTER DEPARTMENT., COMMENT: BASED ON THE AVAILABLE INFORMATION, A CONTRIBUTORY ROLE OF THE SUSPECT PRODUCT GELFOAM TO THE REPORTED EVENT DISEASE RECURRENCE CANNOT BE EXCLUDED. IT WAS REPORTED THAT "TRANSCATHETER ARTERIAL EMBOLIZATION (TAE) USING IODIZED OIL AND GELATIN SPONGE PARTICLES" AND "LOCAL RECURRENCE OCCURRED IN 2 CASES" . CASE WILL BE REASSESSED UPON RECEIPT OF ADDITIONAL INFORMATION. THE IMPACT OF THIS REPORT ON THE BENEFIT/RISK PROFILE OF THE PFIZER PRODUCT IS EVALUATED AS PART OF PFIZER PROCEDURES FOR SAFETY EVALUATION, INCLUDING THE REVIEW AND ANALYSIS OF AGGREGATE DATA FOR ADVERSE EVENTS. ANY SAFETY CONCERN IDENTIFIED AS PART OF THIS REVIEW, AS WELL AS ANY APPROPRIATE ACTION IN RESPONSE, WILL BE PROMPTLY NOTIFIED TO REGULATORY AUTHORITIES, ETHICS COMMITTEES AND INVESTIGATORS, AS APPROPRIATE.