GELFOAM

Description of Event or Problem

EVENT VERBATIM [PREFERRED TERM] INDICATION: GASTRIC VARICES [OFF LABEL USE], INDICATION: GASTRIC VARICES [DEVICE USE ISSUE], ONE PATIENT SUCCUMBED, WITH MODS IN THE COIL + GF GROUP [MULTIPLE ORGAN DYSFUNCTION SYNDROME], , NARRATIVE: THIS IS A LITERATURE REPORT FOR THE FOLLOWING LITERATURE SOURCE(S): "EFFICACY AND SAFETY OF ENDOSCOPIC ULTRASOUND GUIDED COIL EMBOLIZATION WITH ABSORBABLE GELATIN SPONGE VERSUS COIL EMBOLIZATION WITH CYANOACRYLATE GLUE IN GASTRIC VARICES: A RANDOMIZED COMPARATIVE STUDY", GASTROINTESTINAL ENDOSCOPY, 2025; VOL:101(5 SUPPLE), PGS:S561, DOI:10.1016/J.GIE.2025.03.949. A PATIENT (AGE AND GENDER NOT PROVIDED) RECEIVED ABSORBABLE GELATIN (GELFOAM), FOR GASTRIC VARICES. THE PATIENT'S RELEVANT MEDICAL HISTORY WAS NOT REPORTED. THE PATIENT TOOK CONCOMITANT MEDICATIONS. THE FOLLOWING INFORMATION WAS REPORTED: OFF LABEL USE (DEATH, MEDICALLY SIGNIFICANT), DEVICE USE ISSUE (DEATH, MEDICALLY SIGNIFICANT), OUTCOME "FATAL" AND ALL DESCRIBED AS "INDICATION: GASTRIC VARICES"; MULTIPLE ORGAN DYSFUNCTION SYNDROME (DEATH, MEDICALLY SIGNIFICANT), OUTCOME "FATAL", DESCRIBED AS "ONE PATIENT SUCCUMBED, WITH MODS IN THE COIL + GF GROUP". THE PATIENT UNDERWENT THE FOLLOWING LABORATORY TESTS AND PROCEDURES: ENDOSCOPIC ULTRASOUND: UNKNOWN RESULTS; ULTRASOUND DOPPLER: UNKNOWN RESULTS. THE PATIENT DATE OF DEATH WAS UNKNOWN. REPORTED CAUSE OF DEATH: "INDICATION: GASTRIC VARICES", "MULTIPLE ORGAN DYSFUNCTION SYNDROME". IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. CLINICAL COURSE: THIS STUDY AIMS TO COMPARE THE EFFICACY AND SAFETY OF ENDOSCOPIC ULTRASOUND (EUS) GUIDED COIL EMBOLIZATION WITH GELATIN SPONGE (GELFOAM) VERSUS COIL EMBOLIZATION WITH CYA GLUE INJECTION FOR MANAGING PATIENTS WITH GASTRIC VARICES. PATIENTS DIAGNOSED WITH GASTRIC VARICES (GOV2/IGV1) WERE INCLUDED, WITH 70-PATIENTS RANDOMIZED IN 1:1 RATIO INTO TWO GROUPS: EUS-GUIDED COIL EMBOLIZATION WITH ABSORBABLE GELATIN SPONGE (COIL + GF; N = 35) OR EUS-GUIDED COIL EMBOLIZATION WITH CYA (COIL + CYA; N = 35). FOLLOWUP EUS-DOPPLER WAS SCHEDULED AT THE 1 ST, 3 RD, 6 TH AND 12 TH MONTHS POST-INITIAL PROCEDURE TO EVALUATE GASTRIC VARICES REAPPEARANCE, NEED FOR REINTERVENTION, SURVIVAL, AND ADVERSE EVENTS. ONE PATIENT FROM EACH GROUP SUCCUMBED, WITH MODS IN THE COIL + GF GROUP AND SUSPECTED NON-TARGET EMBOLIC EVENT IN THE COIL + CYA GROUP AT 6 WEEKS. CAUSALITY FOR "INDICATION: GASTRIC VARICES" AND "ONE PATIENT SUCCUMBED, WITH MODS IN THE COIL + GF GROUP" WAS DETERMINED ASSOCIATED TO ABSORBABLE GELATIN (MALFUNCTION)., COMMENT: THE EVENT MULTIPLE ORGAN DYSFUNCTION SYNDROME IS ASSESSED AS SERIOUS, ASSOCIATED WITH THE PRODUCT ABSORBABLE GELATIN (GELFOAM) IN THE CONTEXT OF OFF LABEL USE, AND UNLISTED IN THE CDS OF THE PFIZER SUSPECT PRODUCT ABSORBABLE GELATIN. THIS CASE WILL BE REASSESSED WHEN ADDITIONAL INFORMATION IS RECEIVED.

Description of Event or Problem

EVENT [PREFERRED TERM] INDICATION: GASTRIC VARICES [OFF LABEL USE], INDICATION: GASTRIC VARICES [DEVICE USE ISSUE], ONE PATIENT SUCCUMBED, WITH MODS IN THE COIL + GF GROUP [MULTIPLE ORGAN DYSFUNCTION SYNDROME], NARRATIVE: THIS IS A LITERATURE REPORT FOR THE FOLLOWING LITERATURE SOURCE(S): "EFFICACY AND SAFETY OF ENDOSCOPIC ULTRASOUND GUIDED COIL EMBOLIZATION WITH ABSORBABLE GELATIN SPONGE VERSUS COIL EMBOLIZATION WITH CYANOACRYLATE GLUE IN GASTRIC VARICES: A RANDOMIZED COMPARATIVE STUDY", GASTROINTESTINAL ENDOSCOPY, 2025; VOL:101(5 SUPPLE), PGS: S561, DOI: 10.1016/J.GIE.2025.03.949. A PATIENT (AGE AND GENDER NOT PROVIDED) RECEIVED ABSORBABLE GELATIN (GELFOAM), FOR GASTRIC VARICES. THE PATIENT'S RELEVANT MEDICAL HISTORY WAS NOT REPORTED. THE PATIENT TOOK CONCOMITANT MEDICATIONS. THE FOLLOWING INFORMATION WAS REPORTED: OFF LABEL USE (DEATH, MEDICALLY SIGNIFICANT), DEVICE USE ISSUE (DEATH, MEDICALLY SIGNIFICANT), OUTCOME "FATAL" AND ALL DESCRIBED AS "INDICATION: GASTRIC VARICES"; MULTIPLE ORGAN DYSFUNCTION SYNDROME (DEATH, MEDICALLY SIGNIFICANT), OUTCOME "FATAL", DESCRIBED AS "ONE PATIENT SUCCUMBED, WITH MODS IN THE COIL + GF GROUP". THE PATIENT UNDERWENT THE FOLLOWING LABORATORY TESTS AND PROCEDURES: ENDOSCOPIC ULTRASOUND: UNKNOWN RESULTS; ULTRASOUND DOPPLER: UNKNOWN RESULTS. THE PATIENT DATE OF DEATH WAS UNKNOWN. REPORTED CAUSE OF DEATH: "INDICATION: GASTRIC VARICES", "MULTIPLE ORGAN DYSFUNCTION SYNDROME". IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. CLINICAL COURSE: THIS STUDY AIMS TO COMPARE THE EFFICACY AND SAFETY OF ENDOSCOPIC ULTRASOUND (EUS) GUIDED COIL EMBOLIZATION WITH GELATIN SPONGE (GELFOAM) VERSUS COIL EMBOLIZATION WITH CYA GLUE INJECTION FOR MANAGING PATIENTS WITH GASTRIC VARICES. PATIENTS DIAGNOSED WITH GASTRIC VARICES (GOV2/IGV1) WERE INCLUDED, WITH 70-PATIENTS RANDOMIZED IN 1:1 RATIO INTO TWO GROUPS: EUS-GUIDED COIL EMBOLIZATION WITH ABSORBABLE GELATIN SPONGE (COIL + GF; N = 35) OR EUS-GUIDED COIL EMBOLIZATION WITH CYA (COIL + CYA; N = 35). FOLLOWUP EUS-DOPPLER WAS SCHEDULED AT THE 1 ST, 3 RD, 6 TH AND 12 TH MONTHS POST-INITIAL PROCEDURE TO EVALUATE GASTRIC VARICES REAPPEARANCE, NEED FOR REINTERVENTION, SURVIVAL, AND ADVERSE EVENTS. ONE PATIENT FROM EACH GROUP SUCCUMBED, WITH MODS IN THE COIL + GF GROUP AND SUSPECTED NON-TARGET EMBOLIC EVENT IN THE COIL + CYA GROUP AT 6 WEEKS. CAUSALITY FOR "INDICATION: GASTRIC VARICES" AND "ONE PATIENT SUCCUMBED, WITH MODS IN THE COIL + GF GROUP" WAS DETERMINED ASSOCIATED TO ABSORBABLE GELATIN (MALFUNCTION). FOLLOW-UP (14MAY2025): THIS IS A LITERATURE REPORT FOR THE FOLLOWING LITERATURE SOURCE ENTITLED EFFICACY AND SAFETY OF ENDOSCOPIC ULTRASOUND GUIDED COIL EMBOLIZATION WITH ABSORBABLE GELATIN SPONGE VERSUS COIL EMBOLIZATION WITH CYANOACRYLATE GLUE IN GASTRIC VARICES: A RANDOMIZED COMPARATIVE STUDY, GASTROINTESTINAL ENDOSCOPY, 2025, VOL 101(5 SUPPLE), PGS S561, DOI: 10.1016/J.GIE.2025.03.949. 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 INCLUDED: REPORTER INFORMATION., COMMENT: THE EVENT MULTIPLE ORGAN DYSFUNCTION SYNDROME IS ASSESSED AS SERIOUS, ASSOCIATED WITH THE PRODUCT ABSORBABLE GELATIN (GELFOAM) IN THE CONTEXT OF OFF LABEL USE, AND UNLISTED IN THE CDS OF THE PFIZER SUSPECT PRODUCT ABSORBABLE GELATIN. THIS CASE WILL BE REASSESSED WHEN ADDITIONAL INFORMATION IS RECEIVED.

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 THE SITE 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.

Description of Event or Problem

EVENT VERBATIM [PREFERRED TERM] INDICATION: GASTRIC VARICES [OFF LABEL USE], INDICATION: GASTRIC VARICES [DEVICE USE ISSUE], ONE PATIENT SUCCUMBED, WITH MODS IN THE COIL + GF GROUP [MULTIPLE ORGAN DYSFUNCTION SYNDROME], , NARRATIVE: THIS IS A LITERATURE REPORT FROM PRODUCT QUALITY GROUP FOR THE FOLLOWING LITERATURE SOURCE(S): "EFFICACY AND SAFETY OF ENDOSCOPIC ULTRASOUND GUIDED COIL EMBOLIZATION WITH ABSORBABLE GELATIN SPONGE VERSUS COIL EMBOLIZATION WITH CYANOACRYLATE GLUE IN GASTRIC VARICES: A RANDOMIZED COMPARATIVE STUDY", GASTROINTESTINAL ENDOSCOPY, 2025; VOL:101(5 SUPPLE), PGS:S561, DOI:10.1016/J.GIE.2025.03.949. A PATIENT (AGE AND GENDER NOT PROVIDED) RECEIVED ABSORBABLE GELATIN (GELFOAM), FOR GASTRIC VARICES. THE PATIENT'S RELEVANT MEDICAL HISTORY WAS NOT REPORTED. THE PATIENT TOOK CONCOMITANT MEDICATIONS. THE FOLLOWING INFORMATION WAS REPORTED: OFF LABEL USE (DEATH, MEDICALLY SIGNIFICANT), DEVICE USE ISSUE (DEATH, MEDICALLY SIGNIFICANT), OUTCOME "FATAL" AND ALL DESCRIBED AS "INDICATION: GASTRIC VARICES"; MULTIPLE ORGAN DYSFUNCTION SYNDROME (DEATH, MEDICALLY SIGNIFICANT), OUTCOME "FATAL", DESCRIBED AS "ONE PATIENT SUCCUMBED, WITH MODS IN THE COIL + GF GROUP". THE PATIENT UNDERWENT THE FOLLOWING LABORATORY TESTS AND PROCEDURES: ENDOSCOPIC ULTRASOUND: UNKNOWN RESULTS; ULTRASOUND DOPPLER: UNKNOWN RESULTS. THE PATIENT DATE OF DEATH WAS UNKNOWN. REPORTED CAUSE OF DEATH: "INDICATION: GASTRIC VARICES", "MULTIPLE ORGAN DYSFUNCTION SYNDROME". IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. CLINICAL COURSE: THIS STUDY AIMS TO COMPARE THE EFFICACY AND SAFETY OF ENDOSCOPIC ULTRASOUND (EUS) GUIDED COIL EMBOLIZATION WITH GELATIN SPONGE (GELFOAM) VERSUS COIL EMBOLIZATION WITH CYA GLUE INJECTION FOR MANAGING PATIENTS WITH GASTRIC VARICES. PATIENTS DIAGNOSED WITH GASTRIC VARICES (GOV2/IGV1) WERE INCLUDED, WITH 70-PATIENTS RANDOMIZED IN 1:1 RATIO INTO TWO GROUPS: EUS-GUIDED COIL EMBOLIZATION WITH ABSORBABLE GELATIN SPONGE (COIL + GF; N = 35) OR EUS-GUIDED COIL EMBOLIZATION WITH CYA (COIL + CYA; N = 35). FOLLOWUP EUS-DOPPLER WAS SCHEDULED AT THE 1 ST, 3 RD, 6 TH AND 12 TH MONTHS POST-INITIAL PROCEDURE TO EVALUATE GASTRIC VARICES REAPPEARANCE, NEED FOR REINTERVENTION, SURVIVAL, AND ADVERSE EVENTS. ONE PATIENT FROM EACH GROUP SUCCUMBED, WITH MODS IN THE COIL + GF GROUP AND SUSPECTED NON-TARGET EMBOLIC EVENT IN THE COIL + CYA GROUP AT 6 WEEKS. CAUSALITY FOR "INDICATION: GASTRIC VARICES" AND "ONE PATIENT SUCCUMBED, WITH MODS IN THE COIL + GF GROUP" WAS DETERMINED ASSOCIATED TO ABSORBABLE GELATIN (MALFUNCTION). PRODUCT QUALITY GROUP PROVIDED INVESTIGATIONAL RESULTS ON 04JUN2025 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 THE SITE 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.ADDITIONAL PRODUCT QUALITY INFORMATION: "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 THE SITE 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." FOLLOW-UP (14MAY2025): THIS IS A LITERATURE REPORT FOR THE FOLLOWING LITERATURE SOURCE ENTITLED EFFICACY AND SAFETY OF ENDOSCOPIC ULTRASOUND GUIDED COIL EMBOLIZATION WITH ABSORBABLE GELATIN SPONGE VERSUS COIL EMBOLIZATION WITH CYANOACRYLATE GLUE IN GASTRIC VARICES: A RANDOMIZED COMPARATIVE STUDY, GASTROINTESTINAL ENDOSCOPY, 2025, VOL 101(5 SUPPLE), PGS S561, DOI: 10.1016/J.GIE.2025.03.949. 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 INCLUDED: REPORTER INFORMATION. FOLLOW-UP (04JUN2025): THIS IS A FOLLOW-UP REPORT FROM PRODUCT QUALITY GROUP PROVIDING INVESTIGATION RESULTS., COMMENT: THE EVENT MULTIPLE ORGAN DYSFUNCTION SYNDROME IS ASSESSED AS SERIOUS, ASSOCIATED WITH THE PRODUCT ABSORBABLE GELATIN (GELFOAM) IN THE CONTEXT OF OFF LABEL USE, AND UNLISTED IN THE CDS OF THE PFIZER SUSPECT PRODUCT ABSORBABLE GELATIN. THIS CASE WILL BE REASSESSED WHEN ADDITIONAL INFORMATION IS RECEIVED.