BEUDAMED
    FDA Adverse Event Death Summary report: N

    GELFOAM

    MDR report key: 16877399 · Received May 5, 2023

    Report

    Report Number
    1810189-2023-00148
    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] . INDICATION: LIVER TUMORS/TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION [OFF LABEL USE], INDICATION: LIVER TUMORS/TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION [DEVICE USE ISSUE], SPONTANEOUS BACTERIAL PERITONITIS WITH SEPSIS [SPONTANEOUS BACTERIAL PERITONITIS], SPONTANEOUS BACTERIAL PERITONITIS WITH SEPSIS [SEPSIS], GELFOAM PARTICLES WAS CONSIDERED AS A RISK FACTOR FOR LIVER ABSCESS FORMATION AFTER TACE [LIVER ABSCESS], 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 63-YEAR-OLD MALE PATIENT RECEIVED ABSORBABLE GELATIN (GELFOAM), FOR TRANSCATHETER ARTERIAL CHEMOEMBOLISATION. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED: "LIVER TUMORS" (UNSPECIFIED IF ONGOING); "HEPATOCELLULAR CARCINOMA" (UNSPECIFIED IF ONGOING), NOTES: SOLITARY NODULE; SIZE 2 CM; "TRANSCATHETER OILY CHEMOEMBOLIZATION" (UNSPECIFIED IF ONGOING), NOTES: RIGHT HEPATIC ARTERY. THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE FOLLOWING INFORMATION WAS REPORTED: SPONTANEOUS BACTERIAL PERITONITIS (DEATH, HOSPITALIZATION, INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), SEPSIS (DEATH, HOSPITALIZATION, INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "FATAL" AND ALL DESCRIBED AS "SPONTANEOUS BACTERIAL PERITONITIS WITH SEPSIS"; LIVER ABSCESS (HOSPITALIZATION, INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "RECOVERED", DESCRIBED AS "GELFOAM PARTICLES WAS CONSIDERED AS A RISK FACTOR FOR LIVER ABSCESS FORMATION AFTER TACE"; OFF LABEL USE (DEATH, HOSPITALIZATION, INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), DEVICE USE ISSUE (DEATH, HOSPITALIZATION, INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "UNKNOWN" AND ALL DESCRIBED AS "INDICATION: LIVER TUMORS/TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION". THE PATIENT UNDERWENT THE FOLLOWING LABORATORY TESTS AND PROCEDURES: CULTURE: UNKNOWN RESULT; HISTOLOGY: UNKNOWN RESULT; BILARY STATUS: UNKNOWN RESULT; LIVER FUNCTION TEST: UNKNOWN RESULT. THE ACTION TAKEN FOR ABSORBABLE GELATIN WAS UNKNOWN. THERAPEUTIC MEASURES WERE TAKEN AS A RESULT OF LIVER ABSCESS. THE PATIENT DATE OF DEATH WAS UNKNOWN. REPORTED CAUSE OF DEATH: "SPONTANEOUS BACTERIAL PERITONITIS", "SEPSIS". IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. CLINICAL COURSE DETAILS: FOUR PATIENTS (PATIENTS 2, 7, 8, AND 11) DIED WITHIN 4 MONTHS OF HOSPITAL ADMISSION. THE REMAINING TWO PATIENTS SUCCESSFULLY RECOVERED FROM THE LIVER ABSCESS WITH PARENTERAL ANTIBIOTICS AND PCD. HOWEVER, BOTH EVENTUALLY DIED OF SPONTANEOUS BACTERIAL PERITONITIS WITH SEPSIS (PATIENT 11) 2 MONTHS AFTER THE DIAGNOSIS OF LIVER ABSCESS. 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. FOLLOW-UP (30NOV2023): THIS IS A FOLLOW-UP REPORT FROM PRODUCT QUALITY GROUP PROVIDING INVESTIGATION RESULTS. , COMMENT: THE EVENTS OFF LABEL USE, DEVICE USE ISSUES AND LIVER ABSCESS, SPONTANEOUS BACTERIAL PERITONITIS WITH SEPSIS 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] . INDICATION: LIVER TUMORS/TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION [OFF LABEL USE], INDICATION: LIVER TUMORS/TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION [DEVICE USE ISSUE], SPONTANEOUS BACTERIAL PERITONITIS WITH SEPSIS [SPONTANEOUS BACTERIAL PERITONITIS], SPONTANEOUS BACTERIAL PERITONITIS WITH SEPSIS [SEPSIS], GELFOAM PARTICLES WAS CONSIDERED AS A RISK FACTOR FOR LIVER ABSCESS FORMATION AFTER TACE [LIVER ABSCESS], , 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 63-YEAR-OLD MALE PATIENT RECEIVED ABSORBABLE GELATIN (GELFOAM), FOR TRANSCATHETER ARTERIAL CHEMOEMBOLISATION. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED: "LIVER TUMORS" (UNSPECIFIED IF ONGOING); "HEPATOCELLULAR CARCINOMA" (UNSPECIFIED IF ONGOING), NOTES: SOLITARY NODULE; SIZE 2 CM; "TRANSCATHETER OILY CHEMOEMBOLIZATION" (UNSPECIFIED IF ONGOING), NOTES: RIGHT HEPATIC ARTERY. THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE FOLLOWING INFORMATION WAS REPORTED: SPONTANEOUS BACTERIAL PERITONITIS (DEATH, HOSPITALIZATION, INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), SEPSIS (DEATH, HOSPITALIZATION, INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "FATAL" AND ALL DESCRIBED AS "SPONTANEOUS BACTERIAL PERITONITIS WITH SEPSIS"; LIVER ABSCESS (HOSPITALIZATION, INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "RECOVERED", DESCRIBED AS "GELFOAM PARTICLES WAS CONSIDERED AS A RISK FACTOR FOR LIVER ABSCESS FORMATION AFTER TACE"; OFF LABEL USE (DEATH, HOSPITALIZATION, INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), DEVICE USE ISSUE (DEATH, HOSPITALIZATION, INTERVENTION REQUIRED, MEDICALLY SIGNIFICANT), OUTCOME "UNKNOWN" AND ALL DESCRIBED AS "INDICATION: LIVER TUMORS/TRANSCATHETER ARTERIAL CHEMOEMBOLIZATION". THE PATIENT UNDERWENT THE FOLLOWING LABORATORY TESTS AND PROCEDURES: CULTURE: UNKNOWN RESULT; HISTOLOGY: UNKNOWN RESULT; BILARY STATUS: UNKNOWN RESULT; LIVER FUNCTION TEST: UNKNOWN RESULT. THE ACTION TAKEN FOR ABSORBABLE GELATIN WAS UNKNOWN. THERAPEUTIC MEASURES WERE TAKEN AS A RESULT OF LIVER ABSCESS. THE PATIENT DATE OF DEATH WAS UNKNOWN. REPORTED CAUSE OF DEATH: "SPONTANEOUS BACTERIAL PERITONITIS", "SEPSIS". IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. CLINICAL COURSE DETAILS: FOUR PATIENTS (PATIENTS 2, 7, 8, AND 11) DIED WITHIN 4 MONTHS OF HOSPITAL ADMISSION. THE REMAINING TWO PATIENTS SUCCESSFULLY RECOVERED FROM THE LIVER ABSCESS WITH PARENTERAL ANTIBIOTICS AND PCD. HOWEVER, BOTH EVENTUALLY DIED OF SPONTANEOUS BACTERIAL PERITONITIS WITH SEPSIS (PATIENT 11) 2 MONTHS AFTER THE DIAGNOSIS OF LIVER ABSCESS. NO FOLLOW-UP ATTEMPTS ARE POSSIBLE. NO FURTHER INFORMATION IS EXPECTED., COMMENT: THE EVENTS OFF LABEL USE, DEVICE USE ISSUES AND LIVER ABSCESS, SPONTANEOUS BACTERIAL PERITONITIS WITH SEPSIS 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474260 GELFOAM SPONGE, STERILE; CLASS III LMF PFIZER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Other| R| H| D