ABSORBABLE GELATIN

Description of Event or Problem

EVENT VERBATIM [PREFERRED TERM]. INDICATION: THERAPEUTIC EMBOLIZATION [OFF LABEL USE], THERAPEUTIC PRODUCT EFFECTIVE FOR UNAPPROVED INDICATION [THERAPEUTIC PRODUCT EFFECTIVE FOR UNAPPROVED INDICATION], ARTERY EMBOLIZATION WAS SUCCESSFULLY PERFORMED WITH GEL [DEVICE USE ISSUE], , NARRATIVE: THIS IS A LITERATURE REPORT FROM PRODUCT QUALITY GROUP FOR THE FOLLOWING LITERATURE SOURCE(S): "TRANSCATHETER RENAL ARTERIAL EMBOLIZATION FOR INTRACTABLE URINARY FISTULA OCCURRING AFTER ROBOT-ASSISTED PARTIAL NEPHRECTOMY: A CASE REPORT", CEN CASE REPORTS, 2024; VOL:13(6), PGS:425-428, DOI:10.1007/S13730-024-00866-2. A 59-YEAR-OLD MALE PATIENT RECEIVED ABSORBABLE GELATIN (ABSORBABLE GELATIN), FOR THERAPEUTIC EMBOLISATION; ETHIODIZED OIL (LIPIODOL) FOR THERAPEUTIC EMBOLISATION. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED: "RENAL TUMOR" (UNSPECIFIED IF ONGOING). THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE FOLLOWING INFORMATION WAS REPORTED: OFF LABEL USE (NON-SERIOUS), DESCRIBED AS "INDICATION: THERAPEUTIC EMBOLIZATION"; THERAPEUTIC PRODUCT EFFECTIVE FOR UNAPPROVED INDICATION (NON-SERIOUS); DEVICE USE ISSUE (NON-SERIOUS), DESCRIBED AS "ARTERY EMBOLIZATION WAS SUCCESSFULLY PERFORMED WITH GEL". THE ACTION TAKEN FOR ETHIODIZED OIL WAS UNKNOWN. THE REPORTER CONSIDERED "ARTERY EMBOLIZATION WAS SUCCESSFULLY PERFORMED WITH GEL" NOT ASSOCIATED TO ABSORBABLE GELATIN. CAUSALITY FOR "ARTERY EMBOLIZATION WAS SUCCESSFULLY PERFORMED WITH GEL" WAS DETERMINED NOT ASSOCIATED TO ABSORBABLE GELATIN. ADDITIONAL INFORMATION: THE PATIENT WAS A 59-YEAR-OLD MAN. THE PATIENT WAS OPERATED DUE TO RIGHT RENAL TUMOR WITH A DIAMETER OF 28 MM. POSTOPERATIVELY, AN INTRACTABLE URINARY FISTULA WITH AN ISOLATED CALYX DEVELOPED. SELECTIVE ARTERIAL EMBOLIZATION WAS PERFORMED TO PARTIALLY ABOLISH RENAL FUNCTION, WHICH WAS THE CAUSE OF URINE OVERFLOW. GELATIN SPONGES AND LIPIODOL WERE USED TO EMBOLIZE THE SUPPLY VESSELS OF THE LOWER POLE OF THE RIGHT KIDNEY TO REDUCE THE BLOOD FLOW IN THE AREA, WHICH MIGHT HAVE CAUSED THE URINE OVERFLOW. WHEN THE BLOOD FLOW IN THE AREA OF CONTROL WAS INTERRUPTED, THE OVERFLOW OF URINE CEASED. THE DRAIN WAS REMOVED ON THE 49TH POSTOPERATIVE DAY AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. PRODUCT QUALITY COMPLAINT: THE PRODUCT ABSORBABLE GELATIN SPONGE IS OUT OF SCOPE OF DEVICE ENGINEERING INVESTIGATIONS. THE MANUFACTURING SITE (KALAMAZOO) RETAINS DESIGN AUTHORITY FOR THE PRODUCT. THIS RECORD WILL BE CANCELLED. "NO FURTHER INVESTIGATION IS REQUIRED AS NO VALID LOT NUMBER OR RETURNED SAMPLE IS AVAILABLE. THIS COMPLAINT WILL CONTINUE TO BE TRENDED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS COMPLAINT WILL BE REOPENED." FOLLOW-UP (23JAN2025): THIS IS A FOLLOW-UP REPORT FROM PRODUCT QUALITY GROUP. UPDATED INFORMATION: INVESTIGATION SUMMARY.

Description of Event or Problem

EVENT VERBATIM [PREFERRED TERM]. INDICATION: THERAPEUTIC EMBOLIZATION [OFF LABEL USE], THERAPEUTIC PRODUCT EFFECTIVE FOR UNAPPROVED INDICATION [THERAPEUTIC PRODUCT EFFECTIVE FOR UNAPPROVED INDICATION], ARTERY EMBOLIZATION WAS SUCCESSFULLY PERFORMED WITH GEL [DEVICE USE ISSUE], , NARRATIVE: THIS IS A LITERATURE REPORT FOR THE FOLLOWING LITERATURE SOURCE(S): "TRANSCATHETER RENAL ARTERIAL EMBOLIZATION FOR INTRACTABLE URINARY FISTULA OCCURRING AFTER ROBOT-ASSISTED PARTIAL NEPHRECTOMY: A CASE REPORT", CEN CASE REPORTS, 2024; VOL:13(6), PGS:425-428, DOI:10.1007/S13730-024-00866-2. A 59-YEAR-OLD MALE PATIENT RECEIVED ABSORBABLE GELATIN (ABSORBABLE GELATIN), FOR THERAPEUTIC EMBOLISATION; ETHIODIZED OIL (LIPIODOL) FOR THERAPEUTIC EMBOLISATION. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED: "RENAL TUMOR" (UNSPECIFIED IF ONGOING). THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE FOLLOWING INFORMATION WAS REPORTED: OFF LABEL USE (NON-SERIOUS), DESCRIBED AS "INDICATION: THERAPEUTIC EMBOLIZATION"; THERAPEUTIC PRODUCT EFFECTIVE FOR UNAPPROVED INDICATION (NON-SERIOUS); DEVICE USE ISSUE (NON-SERIOUS), DESCRIBED AS "ARTERY EMBOLIZATION WAS SUCCESSFULLY PERFORMED WITH GEL". THE ACTION TAKEN FOR ETHIODIZED OIL WAS UNKNOWN. CAUSALITY FOR "ARTERY EMBOLIZATION WAS SUCCESSFULLY PERFORMED WITH GEL" WAS DETERMINED ASSOCIATED TO ABSORBABLE GELATIN (MALFUNCTION). ADDITIONAL INFORMATION: THE PATIENT WAS A 59-YEAR-OLD MAN. THE PATIENT WAS OPERATED DUE TO RIGHT RENAL TUMOR WITH A DIAMETER OF 28 MM. POSTOPERATIVELY, AN INTRACTABLE URINARY FISTULA WITH AN ISOLATED CALYX DEVELOPED. SELECTIVE ARTERIAL EMBOLIZATION WAS PERFORMED TO PARTIALLY ABOLISH RENAL FUNCTION, WHICH WAS THE CAUSE OF URINE OVERFLOW. GELATIN SPONGES AND LIPIODOL WERE USED TO EMBOLIZE THE SUPPLY VESSELS OF THE LOWER POLE OF THE RIGHT KIDNEY TO REDUCE THE BLOOD FLOW IN THE AREA, WHICH MIGHT HAVE CAUSED THE URINE OVERFLOW. WHEN THE BLOOD FLOW IN THE AREA OF CONTROL WAS INTERRUPTED, THE OVERFLOW OF URINE CEASED. THE DRAIN WAS REMOVED ON THE 49TH POSTOPERATIVE DAY AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL.