BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERA VERITAS TRANSHEPATIC BILIARY SYSTEM

    MDR report key: 2490982 · Received March 9, 2012

    Report

    Report Number
    MW5024600
    Event Type
    Injury
    Date Received
    March 9, 2012
    Date of Event
    February 21, 2012
    Report Date
    February 27, 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

    DELIVERY CATHETER OF THE IDEV SUPERA STENT DISTAL TIP DISLODGED, WITH THE FINAL POSITION IN THE PROXIMAL PERONEAL ARTERY. THE PHYSICIAN FELT "THAT THE MARGINAL BENEFIT OF OPEN RETRIEVAL SURGICALLY IS RELATIVELY LOW GIVEN HIS PRESENT FLOW IN THE LOW EXTREMITY." THE FAMILY (WIFE) AND PHYSICIAN AGREED THAT HE WOULD BE TREATED CONSERVATIVELY AT THIS POINT AND MONITOR FOR WOUND HEALING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUPERA VERITAS TRANSHEPATIC BILIARY SYSTEM SELF-EXPANDING NITINOL STENT 40 MM X 120 X 120 CM FGE IDEV TECHNOLOGIES, INC. S-04-120-120-G3 01126061

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention