BEUDAMED
    FDA Adverse Event Death Summary report: N

    GELFOAM

    MDR report key: 16817298 · Received April 26, 2023

    Report

    Report Number
    1810189-2023-00077
    Event Type
    Death
    Date Received
    April 26, 2023
    Report Date
    April 13, 2023
    Manufacturer
    PFIZER, INC. (DEVICE)
    Product Code
    LMF
    PMA / PMN Number
    18-286
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT QUALITY GROUP PROVIDED INVESTIGATIONAL RESULTS ON 08DEC2023 FOR ABSORBABLE GELATIN: UDI# (B)(4). CONCLUSION: THE COMPLAINT FOR 'ADVERSE EVENT MD/MDCP' FOR AN UNKNOWN BATCH OF GELFOAM SPONGE 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: PARTIAL SPLENIC EMBOLIZATION [OFF LABEL USE], INDICATION: PARTIAL SPLENIC EMBOLIZATION [DEVICE USE ISSUE], GASTROINTESTINAL BLEEDING (ESOPHAHEAL VARICEAL BLEEDING) [GASTROINTESTINAL HAEMORRHAGE], NARRATIVE: THIS IS A LITERATURE REPORT FROM PRODUCT QUALITY GROUP FOR THE FOLLOWING LITERATURE SOURCE(S): "CLINICAL APPLICATION OF KELP MICRO GELATION (KMG) IN PARTIAL SPLENIC EMBOLIZATION", EUROPEAN REVIEW FOR MEDICAL AND PHARMACOLOGICAL SCIENCES, 2018; VOL:22, PGS:1776-1781. A PATIENT (NO QUALIFIERS PROVIDED) RECEIVED ABSORBABLE GELATIN (GELFOAM), AT GELFOAM PARTICLES (50-500 UM), OTHER FOR SPLENIC ARTERY EMBOLISATION. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED: "HYPERSPLENISM" (UNSPECIFIED IF ONGOING); "SPLEEN ENLARGEMENT" (UNSPECIFIED IF ONGOING); "LIVER CIRRHOSIS" (UNSPECIFIED IF ONGOING); "LEUKOPENIA" (UNSPECIFIED IF ONGOING); "THROMBOCYTOPENIA" (UNSPECIFIED IF ONGOING). THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE FOLLOWING INFORMATION WAS REPORTED: OFF LABEL USE (DEATH, MEDICALLY SIGNIFICANT), DEVICE USE ISSUE (DEATH, MEDICALLY SIGNIFICANT), OUTCOME "FATAL" AND ALL DESCRIBED AS "INDICATION: PARTIAL SPLENIC EMBOLIZATION"; GASTROINTESTINAL HAEMORRHAGE (DEATH, MEDICALLY SIGNIFICANT), OUTCOME "FATAL", DESCRIBED AS "GASTROINTESTINAL BLEEDING (ESOPHAHEAL VARICEAL BLEEDING)". THE PATIENT UNDERWENT THE FOLLOWING LABORATORY TESTS AND PROCEDURES: COMPUTERISED TOMOGRAM: UNKNOWN RESULTS; MAGNETIC RESONANCE IMAGING: UNKNOWN RESULTS; PLATELET COUNT: UNKNOWN RESULTS; RED BLOOD CELL COUNT: UNKNOWN RESULTS; WHITE BLOOD CELL COUNT: UNKNOWN RESULTS. THE ACTION TAKEN FOR ABSORBABLE GELATIN WAS UNKNOWN. THE PATIENT DATE OF DEATH WAS UNKNOWN. REPORTED CAUSE OF DEATH: "GASTROINTESTINAL BLEEDING". IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. PRODUCT QUALITY GROUP PROVIDED INVESTIGATIONAL RESULTS ON 08DEC2023 FOR ABSORBABLE GELATIN: UDI# (B)(4). CONCLUSION: THE COMPLAINT FOR 'ADVERSE EVENT MD/MDCP' FOR AN UNKNOWN BATCH OF GELFOAM SPONGE 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. FOLLOW-UP (08DEC2023): THIS IS A FOLLOW-UP REPORT FROM PRODUCT QUALITY GROUP PROVIDING INVESTIGATION RESULTS., COMMENT: THE EVENT FATAL GASTROINTESTINAL BLEEDING (ESOPHAGEAL VARICEAL BLEEDING) IS 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 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 · 0

    EVENT VERBATIM [PREFERRED TERM] GASTROINTESTINAL BLEEDING (ESOPHAHEAL VARICEAL BLEEDING) [GASTROINTESTINAL HAEMORRHAGE].NARRATIVE: THIS IS A LITERATURE REPORT FOR THE FOLLOWING LITERATURE SOURCE: "CLINICAL APPLICATION OF KELP MICRO GELATION (KMG) IN PARTIAL SPLENIC EMBOLIZATION", EUROPEAN REVIEW FOR MEDICAL AND PHARMACOLOGICAL SCIENCES, 2018; VOL:22, PGS:1776-1781. A PATIENT (NO QUALIFIERS PROVIDED) RECEIVED ABSORBABLE GELATIN (GELFOAM), OTHER FOR SPLENIC ARTERY EMBOLISATION. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED: "HYPERSPLENISM" (UNSPECIFIED IF ONGOING); "SPLEEN ENLARGEMENT" (UNSPECIFIED IF ONGOING); "LIVER CIRRHOSIS" (UNSPECIFIED IF ONGOING); "LEUKOPENIA" (UNSPECIFIED IF ONGOING); "THROMBOCYTOPENIA" (UNSPECIFIED IF ONGOING). THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE FOLLOWING INFORMATION WAS REPORTED: GASTROINTESTINAL HAEMORRHAGE (DEATH, MEDICALLY SIGNIFICANT), OUTCOME "FATAL", DESCRIBED AS "GASTROINTESTINAL BLEEDING (ESOPHAHEAL VARICEAL BLEEDING)". CLINICAL COURSE: THIS SUBJECT WAS IDENTIFIED IN GELFOAM-PSE GROUP AFTER PSE FOR 1 MONTH AS HAVING DIED FROM GASTROINTESTINAL BLEEDING (ESOPHAHEAL VARICEAL BLEEDING). THE SUBJECT UNDERWENT THE FOLLOWING LABORATORY TESTS AND PROCEDURES: COMPUTERISED TOMOGRAM: UNKNOWN RESULTS; MAGNETIC RESONANCE IMAGING: UNKNOWN RESULTS; PLATELET COUNT: UNKNOWN RESULTS; RED BLOOD CELL COUNT: UNKNOWN RESULTS; WHITE BLOOD CELL COUNT: UNKNOWN RESULTS. THE ACTION TAKEN FOR ABSORBABLE GELATIN WAS UNKNOWN. THE PATIENT DATE OF DEATH WAS UNKNOWN. REPORTED CAUSE OF DEATH: "GASTROINTESTINAL BLEEDING". IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. NO FOLLOW-UP ATTEMPTS POSSIBLE. NO FURTHER INFORMATION EXPECTED., COMMENT: THE EVENT FATAL GASTROINTESTINAL BLEEDING (ESOPHAGEAL VARICEAL BLEEDING) IS 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 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490208 GELFOAM SPONGE, STERILE; CLASS III LMF PFIZER, INC. (DEVICE)

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| O| D