BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT VASCULAR

    MDR report key: 3525235 · Received December 12, 2013

    Report

    Report Number
    MW5033484
    Event Type
    Malfunction
    Date Received
    December 12, 2013
    Date of Event
    December 6, 2013
    Report Date
    December 12, 2013
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    STENT DID NOT FULLY DEPLOY IN ARTERY. AFTER THIS, ATTEMPTED TO REMOVE STENT DELIVERY SYSTEM AT WHICH TIME THE STENT GOT STUCK ON THE END OF THE SHUTTLE SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650232 ABBOTT VASCULAR ACCULINK NIM ABBOTT VASCULAR 1011343-40 3030461

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR