BEUDAMED
    FDA Adverse Event Death Summary report: N

    GELWEAVE

    MDR report key: 5070230 · Received September 11, 2015

    Report

    Report Number
    9612515-2015-00024
    Event Type
    Death
    Date Received
    September 11, 2015
    Date of Event
    May 25, 2015
    Report Date
    September 30, 2015
    Manufacturer
    VASCUTEK LTD.
    Product Code
    DSY
    PMA / PMN Number
    K013022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PROCESS EVALUATION- REVIEW OF RETAINED QC AND MANUFACTURING RECORDS CARRIED OUT.RESULT CODE -FAILURE DETECTED - BATCH MANUFACTURED TO DESIGN SPECIFICATIONCONCLUSION CODE- CONCLUSION NOT YET AVAILABLE - EVALUATION OF RETURNED EXPLANT IN PROGRESS.

    Additional Manufacturer Narrative · 1

    METHOD: SECTION OF ACTUAL DEVICE EVALUATED. METHOD: VISUAL INSPECTION OF RETURNED SAMPLE CARRIED OUT. METHOD: SCANNING ELECTRON MICROSCOPE(SEM) EXAMINATION OF RETURNED SAMPLE CARRIED OUT. RESULT: NO FAILURE DETECTED, NO FLAWS OR DEFECTS FOUND ON RETURNED SAMPLE. CONCLUSION: UNABLE TO CONFIRM COMPLAINT. RETURNED SECTION FREE FROM DEFECTS. CONCLUSION: NO FAILURE OR INSUFFICIENCY WAS FOUND WITH THE SAMPLE TESTED. THIS ISSUE WILL BE TRACKED AND TRENDED AS PART OF THE ROUTINE COMPLAINTS MONITORING AND REPORTING PROCESS. IF AN ADVERSE TREND DEVELOPS, ACTION MAY BE TAKEN AT THAT TIME. VASCUTEK NOW CONSIDERS THIS COMPLAINT AS CLOSED.

    Description of Event or Problem · 1

    THE EVENT WAS DESCRIBED TO VASCUTEK (B)(4); PATIENT DIED SUDDENLY DURING THE NIGHT BETWEEN 4TH AND 5TH POST-OPERATIVE DAYS AFTER A BENTAL PROCEDURE. GELWEAVE VALSALVA WAS USED WITH PERIMOUNT MAGNA EASE EDWARDS LIFSCIENCES VALVE. IN MEDICO-LEGAL POSTMORTUM FOUND THROMBUS MASS AT THE OSTIA OF BOTH CORONARIES AND ISCHEMIA IN MYOCARDIAL TISSUE. AT THE MOMENT IT SEEMS THAT THE PATIENT DIED OF ACUTE MYOCARDIAL ISCHEMIA CAUSED BY THROMBUS BLOCKING BOTH CORONARY OSTIA. THE FINAL MEDICO-LEGAL REPORT IS NOT AVAILABLE YET. POST-OPERATIVE PHASE GOING WELL. PATIENT WAS GETTING BETTER. 3 HOURS BEFORE DEATH PATIENT HAD REPORTED SHOULDER AND CHEST PAIN WHICH PROBABLY PASSED WITH MEDICATION "

    Description of Event or Problem · 1

    THIS REPORT IS BEING SUBMITTED AS A FOLLOW UP #1 FOR MFG REPORT NO. 9612515-2015-00024 TO PROVIDE NEW INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602682 GELWEAVE GELWEAVE VALSALVA DSY VASCUTEK LTD. GELWEAVE VALSALVA 345531

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death