BEUDAMED
    FDA Adverse Event Death Summary report: N

    GELFOAM

    MDR report key: 16807428 · Received April 25, 2023

    Report

    Report Number
    1810189-2023-00060
    Event Type
    Death
    Date Received
    April 25, 2023
    Report Date
    April 12, 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
    OTHER
    Health Professional
    N

    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: HAEMOPTYSIS/BRONCHIAL ARTERY EMBOLIZATION [OFF LABEL USE]. INDICATION: HAEMOPTYSIS/BRONCHIAL ARTERY EMBOLIZATION [DEVICE USE ISSUE]. INDICATION: HAEMOPTYSIS/BRONCHIAL ARTERY EMBOLIZATION/RE-BLEEDING/RECURRENT HAEMOPTYSIS [DRUG INEFFECTIVE FOR UNAPPROVED INDICATION]. NARRATIVE: THIS IS A LITERATURE REPORT FOR THE FOLLOWING LITERATURE SOURCE(S): "LONG TERM EFFECTS OF BRONCHIAL ARTERY EMBOLIZATION IN KOREAN PATIENTS WITH HAEMOPTYSIS", RESPIROLOGY, 2006; VOL:11 (6), PGS:776-781, DOI:10.1111/J.1400-1843.2006.00946.X. A PATIENT (AGE AND GENDER NOT PROVIDED) RECEIVED ABSORBABLE GELATIN (GELFOAM), FOR BRONCHIAL ARTERY EMBOLISATION. THE PATIENT'S RELEVANT MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE FOLLOWING INFORMATION WAS REPORTED: OFF LABEL USE (DEATH, HOSPITALIZATION, MEDICALLY SIGNIFICANT), DEVICE USE ISSUE (DEATH, HOSPITALIZATION, MEDICALLY SIGNIFICANT), OUTCOME "FATAL" AND ALL DESCRIBED AS "INDICATION: HAEMOPTYSIS/BRONCHIAL ARTERY EMBOLIZATION"; DRUG INEFFECTIVE FOR UNAPPROVED INDICATION (DEATH, HOSPITALIZATION, MEDICALLY SIGNIFICANT), OUTCOME "FATAL", DESCRIBED AS "INDICATION: HAEMOPTYSIS/BRONCHIAL ARTERY EMBOLIZATION/RE-BLEEDING/RECURRENT HAEMOPTYSIS". THE PATIENT UNDERWENT THE FOLLOWING LABORATORY TESTS AND PROCEDURES: ANGIOGRAM: UNKNOWN RESULTS; ASPERGILLUS INFECTION: UNKNOWN RESULTS; BRONCHOSCOPY: UNKNOWN RESULTS, NOTES: PERFORMED TO HELP IDENTIFY THE BLEEDING FOCI; COMPUTERISED TOMOGRAM THORAX: UNKNOWN RESULTS, NOTES: PERFORMED TO HELP IDENTIFY THE BLEEDING FOCI; AMOUNT OF HAEMOPTYSIS: UNKNOWN RESULTS, NOTES: UNITS: ML/24H; PULMONARY FUNCTION TEST: UNKNOWN RESULTS. THE PATIENT DATE OF DEATH WAS UNKNOWN. REPORTED CAUSE OF DEATH: "INDICATION: HAEMOPTYSIS/BRONCHIAL ARTERY EMBOLIZATION", "RE-BLEEDING/RECURRENT HAEMOPTYSIS". IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. CLINICAL COURSE: PATIENTS WERE SEPARATED INTO A RE-BLEEDING GROUP, DEFINED AS THOSE WHO REQUIRED READMISSION TO CONTROL RECURRENT HAEMOPTYSIS, AND A NON-REBLEEDING GROUP. NO FOLLOW-UP ATTEMPTS ARE POSSIBLE. NO FURTHER INFORMATION IS EXPECTED. FOLLOW-UP (21NOV2023): THIS IS A FOLLOW-UP REPORT FROM PRODUCT QUALITY GROUP PROVIDING INVESTIGATION RESULTS. PRODUCT QUALITY GROUP PROVIDED INVESTIGATIONAL RESULTS ON 21NOV2023 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. COMMENT: THE EVENTS OF THERAPEUTIC PRODUCT INEFFECTIVE FOR UNAPPROVED INDICATION AND OFF LABEL USE , DEVICE USE ISSUE 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 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] INDICATION: HAEMOPTYSIS/BRONCHIAL ARTERY EMBOLIZATION [OFF LABEL USE], INDICATION: HAEMOPTYSIS/BRONCHIAL ARTERY EMBOLIZATION/RE-BLEEDING/RECURRENT HAEMOPTYSIS [DRUG INEFFECTIVE FOR UNAPPROVED INDICATION], , NARRATIVE: THIS IS A LITERATURE REPORT FOR THE FOLLOWING LITERATURE SOURCE(S): "LONG TERM EFFECTS OF BRONCHIAL ARTERY EMBOLIZATION IN KOREAN PATIENTS WITH HAEMOPTYSIS", RESPIROLOGY, 2006; VOL:11 (6), PGS:776-781, DOI:10.1111/J.1400-1843.2006.00946.X. A PATIENT (NO QUALIFIERS PROVIDED) RECEIVED ABSORBABLE GELATIN (GELFOAM), FOR BRONCHIAL ARTERY EMBOLISATION. THE PATIENT'S RELEVANT MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE FOLLOWING INFORMATION WAS REPORTED: OFF LABEL USE (DEATH, HOSPITALIZATION, MEDICALLY SIGNIFICANT), OUTCOME "FATAL", DESCRIBED AS "INDICATION: HAEMOPTYSIS/BRONCHIAL ARTERY EMBOLIZATION"; DRUG INEFFECTIVE FOR UNAPPROVED INDICATION (DEATH, HOSPITALIZATION, MEDICALLY SIGNIFICANT), OUTCOME "FATAL", DESCRIBED AS "INDICATION: HAEMOPTYSIS/BRONCHIAL ARTERY EMBOLIZATION/RE-BLEEDING/RECURRENT HAEMOPTYSIS". THE PATIENT UNDERWENT THE FOLLOWING LABORATORY TESTS AND PROCEDURES: ANGIOGRAM: UNKNOWN RESULTS; ASPERGILLUS INFECTION: UNKNOWN RESULTS; BRONCHOSCOPY: UNKNOWN RESULTS, NOTES: PERFORMED TO HELP IDENTIFY THE BLEEDING FOCI; COMPUTERISED TOMOGRAM THORAX: UNKNOWN RESULTS, NOTES: PERFORMED TO HELP IDENTIFY THE BLEEDING FOCI; AMOUNT OF HAEMOPTYSIS: UNKNOWN RESULTS, NOTES: UNITS: ML/24H; PULMONARY FUNCTION TEST: UNKNOWN RESULTS. THE PATIENT DATE OF DEATH WAS UNKNOWN. REPORTED CAUSE OF DEATH: "INDICATION: HAEMOPTYSIS/BRONCHIAL ARTERY EMBOLIZATION", "RE-BLEEDING/RECURRENT HAEMOPTYSIS". IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. CLINICAL COURSE: PATIENTS WERE SEPARATED INTO A RE-BLEEDING GROUP, DEFINED AS THOSE WHO REQUIRED READMISSION TO CONTROL RECURRENT HAEMOPTYSIS, AND A NON-REBLEEDING GROUP. NO FOLLOW-UP ATTEMPTS ARE POSSIBLE. NO FURTHER INFORMATION IS EXPECTED., COMMENT: THE EVENTS OF THERAPEUTIC PRODUCT INEFFECTIVE FOR UNAPPROVED INDICATION AND OFF LABEL USE 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
    1092466 GELFOAM SPONGE, STERILE; CLASS III LMF PFIZER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other| H| D