BEUDAMED
    FDA Adverse Event Death Summary report: N

    GELFOAM

    MDR report key: 16877411 · Received May 5, 2023

    Report

    Report Number
    1810189-2023-00141
    Event Type
    Death
    Date Received
    May 5, 2023
    Report Date
    April 25, 2023
    Manufacturer
    PFIZER, INC.
    Product Code
    LMF
    PMA / PMN Number
    18-286
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCLUSION: THE COMPLAINT FOR 'PERFORMANCE NOT AS INDICATED IN LABEL' 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.

    Description of Event or Problem · 0

    EVENT VERBATIM [PREFERRED TERM] GELFOAM FOR LIVER TUMORS/TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION [OFF LABEL USE], GELFOAM FOR LIVER TUMORS/TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION [DEVICE USE ISSUE], GELFOAM PARTICLES WAS CONSIDERED AS A RISK FACTOR FOR LIVER ABSCESS FORMATION AFTER TACE [LIVER ABSCESS], ACUTE HEPATIC FAILURE [ACUTE HEPATIC FAILURE], , NARRATIVE: THIS IS A LITERATURE REPORT FOR THE FOLLOWING LITERATURE SOURCE(S): "LIVER ABSCESS AFTER TRANSCATHETER OILY CHEMOEMBOLIZATION FOR HEPATIC TUMORS: INCIDENCE, PREDISPOSING FACTORS, AND CLINICAL OUTCOME", JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY, 2001; VOL:12 (3), PGS:313-320. A 43-YEAR-OLD MALE PATIENT RECEIVED ABSORBABLE GELATIN (GELFOAM), FOR HEPATIC NEOPLASM. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED: "LIVER TUMORS" (UNSPECIFIED IF ONGOING); "HEPATOCELLULAR CARCINOMA" (UNSPECIFIED IF ONGOING); "PORTAL VEIN OCCLUSION" (UNSPECIFIED IF ONGOING); "TRANSCATHETER OILY CHEMOEMBOLIZATION" (UNSPECIFIED IF ONGOING); "DIABETES MELLITUS" (UNSPECIFIED IF ONGOING); "EMPYEMA" (UNSPECIFIED IF ONGOING). THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE FOLLOWING INFORMATION WAS REPORTED: OFF LABEL USE (DEATH, HOSPITALIZATION, INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), DEVICE USE ISSUE (DEATH, HOSPITALIZATION, INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "FATAL" AND ALL DESCRIBED AS "GELFOAM FOR LIVER TUMORS/TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION"; LIVER ABSCESS (DEATH, HOSPITALIZATION, INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "FATAL", DESCRIBED AS "GELFOAM PARTICLES WAS CONSIDERED AS A RISK FACTOR FOR LIVER ABSCESS FORMATION AFTER TACE"; ACUTE HEPATIC FAILURE (DEATH, HOSPITALIZATION, INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "FATAL". THE PATIENT UNDERWENT THE FOLLOWING LABORATORY TESTS AND PROCEDURES: COMPUTERISED TOMOGRAM: COMMUNICATION BETWEEN EMPYEMA, NOTES: AND LIVER ABSCESS THROUGH A DIAPHRAGMATIC DEFECT SEEN; CULTURE: UNKNOWN RESULT; HISTOLOGY: UNKNOWN RESULT; BILARY STATUS: INTACT; 10, NOTES: CM; LIVER FUNCTION TEST: UNKNOWN RESULT. THE ACTION TAKEN FOR ABSORBABLE GELATIN WAS UNKNOWN. THERAPEUTIC MEASURES WERE TAKEN AS A RESULT OF OFF LABEL USE, DEVICE USE ISSUE, LIVER ABSCESS, ACUTE HEPATIC FAILURE. THE PATIENT DATE OF DEATH WAS UNKNOWN. REPORTED CAUSE OF DEATH: "ACUTE HEPATIC FAILURE", "LIVER ABSCESS". IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. CLINICAL COURSE: PATIENT DIED WITHIN 4 MONTHS OF HOSPITAL ADMISSION. THE PATIENT DIED OF DEVELOPMENT OF INTRAVENOUS CHEMOTHERAPY-INDUCED ACUTE HEPATIC FAILURE. HIS HEPATIC FUNCTION HAD RECOVERED TO THE PREEMBOLIZATION LEVEL 10 DAYS AFTER PCD. PRODUCT QUALITY GROUP PROVIDED INVESTIGATIONAL RESULTS ON 30NOV2023 FOR ABSORBABLE GELATIN: CONCLUSION: THE COMPLAINT FOR 'PERFORMANCE NOT AS INDICATED IN LABEL' 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. UDI: (B)(4). NO FOLLOW-UP ATTEMPTS ARE POSSIBLE. NO FURTHER INFORMATION IS EXPECTED. AMENDMENT: THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO ALLOW APPROPRIATE REPORTING TO HEALTH AUTHORITIES. FOLLOW-UP (30NOV2023): THIS IS A FOLLOW-UP REPORT FROM PRODUCT QUALITY GROUP PROVIDING INVESTIGATION RESULTS., COMMENT: THE EVENT OFF LABEL USE, DEVICE USE ISSUES, LIVER ABSCESS AND ACUTE HEPATIC FAILURE ARE ASSESSED AS SERIOUS, ASSOCIATED WITH THE PRODUCT ABSORBABLE GELATIN (GELFOAM), AND UNLISTED IN THE CDS OF THE PFIZER SUSPECT PRODUCT ABSORBABLE GELATIN. THIS CASE WILL BE REASSESSED WHEN ADDITIONAL INFORMATION IS RECEIVED. THE FOLLOW-UP INFORMATION RECEIVED DOES NOT ALTER THE PREVIOUS COMPANY CLINICAL EVALUATION.

    Description of Event or Problem · 0

    EVENT VERBATIM [PREFERRED TERM] . GELFOAM FOR LIVER TUMORS/TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION [OFF LABEL USE], GELFOAM FOR LIVER TUMORS/TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION [DEVICE USE ISSUE], GELFOAM PARTICLES WAS CONSIDERED AS A RISK FACTOR FOR LIVER ABSCESS FORMATION AFTER TACE [LIVER ABSCESS], UNCONTROLLABLE ACUTE HEPATIC FAILURE WAS [ACUTE HEPATIC FAILURE], , NARRATIVE: THIS IS A LITERATURE REPORT FOR THE FOLLOWING LITERATURE SOURCE(S): "LIVER ABSCESS AFTER TRANSCATHETER OILY CHEMOEMBOLIZATION FOR HEPATIC TUMORS: INCIDENCE, PREDISPOSING FACTORS, AND CLINICAL OUTCOME", JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY, 2001; VOL:12 (3), PGS:313-320. A 43-YEAR-OLD MALE PATIENT RECEIVED ABSORBABLE GELATIN (GELFOAM), FOR HEPATIC NEOPLASM. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED: "LIVER TUMORS" (UNSPECIFIED IF ONGOING); "HEPATOCELLULAR CARCINOMA" (UNSPECIFIED IF ONGOING); "PORTAL VEIN OCCLUSION" (UNSPECIFIED IF ONGOING); "TRANSCATHETER OILY CHEMOEMBOLIZATION" (UNSPECIFIED IF ONGOING); "DIABETES MELLITUS" (UNSPECIFIED IF ONGOING); "EMPYEMA" (UNSPECIFIED IF ONGOING). THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE FOLLOWING INFORMATION WAS REPORTED: OFF LABEL USE (DEATH, HOSPITALIZATION, INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), DEVICE USE ISSUE (DEATH, HOSPITALIZATION, INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "FATAL" AND ALL DESCRIBED AS "GELFOAM FOR LIVER TUMORS/TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION"; LIVER ABSCESS (DEATH, HOSPITALIZATION, INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "FATAL", DESCRIBED AS "GELFOAM PARTICLES WAS CONSIDERED AS A RISK FACTOR FOR LIVER ABSCESS FORMATION AFTER TACE"; ACUTE HEPATIC FAILURE (DEATH, HOSPITALIZATION, INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "FATAL", DESCRIBED AS "UNCONTROLLABLE ACUTE HEPATIC FAILURE WAS". THE PATIENT UNDERWENT THE FOLLOWING LABORATORY TESTS AND PROCEDURES: COMPUTERISED TOMOGRAM: COMMUNICATION BETWEEN EMPYEMA, NOTES: AND LIVER ABSCESS THROUGH A DIAPHRAGMATIC DEFECT SEEN; CULTURE: UNKNOWN RESULT; HISTOLOGY: UNKNOWN RESULT; BILARY STATUS: INTACT; 10, NOTES: CM; LIVER FUNCTION TEST: UNKNOWN RESULT. THE ACTION TAKEN FOR ABSORBABLE GELATIN WAS UNKNOWN. THERAPEUTIC MEASURES WERE TAKEN AS A RESULT OF OFF LABEL USE, DEVICE USE ISSUE, LIVER ABSCESS, ACUTE HEPATIC FAILURE. THE PATIENT DATE OF DEATH WAS UNKNOWN. REPORTED CAUSE OF DEATH: "ACUTE HEPATIC FAILURE", "LIVER ABSCESS ". IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. CLINICAL COURSE: PATIENT DIED WITHIN 4 MONTHS OF HOSPITAL ADMISSION. UNCONTROLLABLE ACUTE HEPATIC FAILURE WAS THE CAUSE OF DEATH, WHO DIED 61 DAYS AFTER THE DIAGNOSIS OF LIVER ABSCESS. NO FOLLOW-UP ATTEMPTS ARE POSSIBLE. NO FURTHER INFORMATION IS EXPECTED., COMMENT: THE EVENT OFF LABEL USE, DEVICE USE ISSUES, LIVER ABSCESS AND ACUTE HEPATIC FAILURE ARE ASSESSED AS SERIOUS, ASSOCIATED WITH THE PRODUCT ABSORBABLE GELATIN (GELFOAM), 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 · 0

    EVENT VERBATIM [PREFERRED TERM] GELFOAM FOR LIVER TUMORS/TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION [OFF LABEL USE], GELFOAM FOR LIVER TUMORS/TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION [DEVICE USE ISSUE], GELFOAM PARTICLES WAS CONSIDERED AS A RISK FACTOR FOR LIVER ABSCESS FORMATION AFTER TACE [LIVER ABSCESS], ACUTE HEPATIC FAILURE [ACUTE HEPATIC FAILURE], , NARRATIVE: THIS IS A LITERATURE REPORT FOR THE FOLLOWING LITERATURE SOURCE(S): "LIVER ABSCESS AFTER TRANSCATHETER OILY CHEMOEMBOLIZATION FOR HEPATIC TUMORS: INCIDENCE, PREDISPOSING FACTORS, AND CLINICAL OUTCOME", JOURNAL OF VASCULAR AND INTERVENTIONAL RADIOLOGY, 2001; VOL:12 (3), PGS:313-320. A 43-YEAR-OLD MALE PATIENT RECEIVED ABSORBABLE GELATIN (GELFOAM), FOR HEPATIC NEOPLASM. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED: "LIVER TUMORS" (UNSPECIFIED IF ONGOING); "HEPATOCELLULAR CARCINOMA" (UNSPECIFIED IF ONGOING); "PORTAL VEIN OCCLUSION" (UNSPECIFIED IF ONGOING); "TRANSCATHETER OILY CHEMOEMBOLIZATION" (UNSPECIFIED IF ONGOING); "DIABETES MELLITUS" (UNSPECIFIED IF ONGOING); "EMPYEMA" (UNSPECIFIED IF ONGOING). THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE FOLLOWING INFORMATION WAS REPORTED: OFF LABEL USE (DEATH, HOSPITALIZATION, INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), DEVICE USE ISSUE (DEATH, HOSPITALIZATION, INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "FATAL" AND ALL DESCRIBED AS "GELFOAM FOR LIVER TUMORS/TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION"; LIVER ABSCESS (DEATH, HOSPITALIZATION, INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "FATAL", DESCRIBED AS "GELFOAM PARTICLES WAS CONSIDERED AS A RISK FACTOR FOR LIVER ABSCESS FORMATION AFTER TACE"; ACUTE HEPATIC FAILURE (DEATH, HOSPITALIZATION, INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "FATAL". THE PATIENT UNDERWENT THE FOLLOWING LABORATORY TESTS AND PROCEDURES: COMPUTERISED TOMOGRAM: COMMUNICATION BETWEEN EMPYEMA, NOTES: AND LIVER ABSCESS THROUGH A DIAPHRAGMATIC DEFECT SEEN; CULTURE: UNKNOWN RESULT; HISTOLOGY: UNKNOWN RESULT; BILARY STATUS: INTACT; 10, NOTES: CM; LIVER FUNCTION TEST: UNKNOWN RESULT. THE ACTION TAKEN FOR ABSORBABLE GELATIN WAS UNKNOWN. THERAPEUTIC MEASURES WERE TAKEN AS A RESULT OF OFF LABEL USE, DEVICE USE ISSUE, LIVER ABSCESS, ACUTE HEPATIC FAILURE. THE PATIENT DATE OF DEATH WAS UNKNOWN. REPORTED CAUSE OF DEATH: "ACUTE HEPATIC FAILURE", "LIVER ABSCESS". IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. CLINICAL COURSE: PATIENT DIED WITHIN 4 MONTHS OF HOSPITAL ADMISSION. THE PATIENT DIED OF DEVELOPMENT OF INTRAVENOUS CHEMOTHERAPY-INDUCED ACUTE HEPATIC FAILURE. HIS HEPATIC FUNCTION HAD RECOVERED TO THE PREEMBOLIZATION LEVEL 10 DAYS AFTER PCD. NO FOLLOW-UP ATTEMPTS ARE POSSIBLE. NO FURTHER INFORMATION IS EXPECTED. AMENDMENT: THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO ALLOW APPROPRIATE REPORTING TO HEALTH AUTHORITIES., COMMENT: THE EVENT OFF LABEL USE, DEVICE USE ISSUES, LIVER ABSCESS AND ACUTE HEPATIC FAILURE ARE ASSESSED AS SERIOUS, ASSOCIATED WITH THE PRODUCT ABSORBABLE GELATIN (GELFOAM), AND UNLISTED IN THE CDS OF THE PFIZER SUSPECT PRODUCT ABSORBABLE GELATIN. THIS CASE WILL BE REASSESSED WHEN ADDITIONAL INFORMATION IS RECEIVED. THE FOLLOW-UP INFORMATION RECEIVED DOES NOT ALTER THE PREVIOUS COMPANY CLINICAL EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475230 GELFOAM SPONGE, STERILE; CLASS III LMF PFIZER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Male Other| R| D| H