BEUDAMED
    FDA Adverse Event Death Summary report: N

    ABBOTT VASCULAR PROGLIDE PERCLOSE VASCULAR DEVICE

    MDR report key: 10355728 · Received July 31, 2020

    Report

    Report Number
    MW5095838
    Event Type
    Death
    Date Received
    July 31, 2020
    Date of Event
    November 12, 2019
    Report Date
    July 29, 2020
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    BREAKAGE OF ABBOTT PROGLIDE PERCLOSE VASCULAR CLOSURE DEVICE AFTER SUCCESSFUL ANGIOPLASTY OF LEFT TIBIAL ARTERY STENOSIS. BREAKAGE RESULTED IN MASSIVE HEMORRHAGING, ABDOMINAL HEMATOMA, AND ADDITIONAL 4 HOURS OF SURGERY TO RETRIEVE DEVICE AND REPAIR THE FEMORAL ARTERY. HEMORRHAGIC SHOCK REQUIRED INITIAL TRANSFUSION OF 5 UNITS OF PRBC'S, PLASMA AND PLATELETS. (B)(6) (PATIENT) REQUIRED EMERGENT INTUBATION, EPI BOLUSES EVERY 2 MIN FOR 4 HOURS, AND WAS TRANSPORTED TO THE CICU ON 5 PRESSORS AND 12 IV LINES AND ON A VENTILATOR. HE REMAINED IN INTENSIVE CARE UNTIL THE TIME OF HIS DEATH ON (B)(6) 2019. CAUSE OF DEATH WAS HEMORRHAGIC SHOCK. DR. (B)(6) WAS THE INTERVENTIONIST UTILIZING THE DEVICE AT (B)(6) MEDICAL CENTER IN (B)(6) AND HE DOCUMENTED IN THE MEDICAL RECORD THAT THE DEVICE WAS SENT TO ABBOTT FOR ANALYSIS AND THAT BOTH THE ANALYSIS AND THE BROKEN DEVICE WERE FORWARDED TO THE FDA BY ABBOTT VASCULAR. NO INFORMATION FROM THE REPORT WAS SHARED WITH FAMILY MEMBERS. THERE APPEAR TO BE 3 MAUDE REPORTS THAT MAY RELATE TO THIS CASE. REPORT NUMBERS 2024168-2019-14027; 2024168-2019-14043; AND 2024168-2019-14045. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817491 ABBOTT VASCULAR PROGLIDE PERCLOSE VASCULAR DEVICE DEVICE, HEMOSTASIS, VASCULAR MGB ABBOTT VASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death| H| L| R| S