BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERA VERITAS INTERWOVEN

    MDR report key: 2522607 · Received April 6, 2012

    Report

    Report Number
    MW5024900
    Event Type
    Injury
    Date Received
    April 6, 2012
    Date of Event
    March 20, 2012
    Report Date
    March 20, 2012
    Manufacturer
    IDEV TECHNOLOGIES INC.
    Product Code
    FGE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    STENT POSITIONED AND DEPLOYED IN THE RETROGENICULATE POPLITEAL ARTERY ACCORDING TO MANUFACTURERS INSTRUCTIONS FOR USE. DEVICE REPRESENTATIVE PRESENT AND CONFIRMED EACH STEP OF DEPLOYMENT. DISTAL TIP OF THE DELIVERY CATHETER WAS BROKEN OFF AND REMAINED AS A RETAINED FOREIGN BODY IN THE PT'S POPLITEAL ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPTIC BILIARY SYSTEM FGE IDEV TECHNOLOGIES INC. S-04-100-120-6F 01190054

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Hospitalization| R