BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESTENT VASCULAR STEN SYSTEM

    MDR report key: 3022961 · Received March 21, 2013

    Report

    Report Number
    9681442-2013-00026
    Event Type
    Malfunction
    Date Received
    March 21, 2013
    Date of Event
    February 23, 2013
    Report Date
    February 24, 2013
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    NIP
    PMA / PMN Number
    P070014/S035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS PROVIDED AND THE DEVICE HISTORY RECORDS ARE BEING REVIEWED. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A STENT WAS FOUND CONSTRICTED AFTER IMPLANTATION, WHICH APPEARS TO BE FRACTURED. A BALLOON WAS USED TO EXPAND THE STENT BUT THE BALLOON COULD NOT GO THROUGH THE STENT. SO THE BALLOON WAS REMOVED AND THE PROCEDURE WAS CLOSED. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117471 LIFESTENT VASCULAR STEN SYSTEM NIP ANGIOMED GMBH & CO. MEDIZINTECHNIK KG 03/31/2014

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR