BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFESTENT VASCULAR STENT

    MDR report key: 2103747 · Received May 17, 2011

    Report

    Report Number
    9681442-2011-00023
    Event Type
    Injury
    Date Received
    May 17, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 22, 2011
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK
    Product Code
    NIP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT IS BEING REPORTED BECAUSE THIS DEVICE IS THE SAME OR SIMILAR TO PMA #P070014, MARKETED IN THE UNITED STATES. THE DEVICE HISTORY RECORDS ARE BEING REVIEWED. THE SAMPLE HAS BEEN RECEIVED AND IS BEING EVALUATED. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STENT COULD ONLY BE PARTIALLY DEPLOYED. AFTER AN OPEN SURGICAL PROCEDURE TO PLACE A VASCULAR ARTERIAL PATCH, THE PHYSICIAN DECIDED TO SUPPORT THE VESSEL BY INSERTING A STENT. REPORTEDLY, DURING DEPLOYMENT, THE DELIVERY SYSTEM JAMMED. THE STENT COULD ONLY BE PARTIALLY RELEASED, AND COULD NOT BE RETRACTED INTO THE CATHETER. IN ADDITION, THE DELIVERY SYSTEM COULD NOT BE REMOVED. THE ARTERIAL PATCH WAS RE-OPENED, THE STENT WAS RESECTED, AND THE DELIVERY SYSTEM WAS SUCCESSFULLY REMOVED. ANOTHER STENT WAS PLACED, AND THE PATCH WAS RE-CLOSED. THERE WERE NO RESIDUAL CLINICAL CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESTENT VASCULAR STENT NIP ANGIOMED GMBH & CO. MEDIZINTECHNIK ANUF0759

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention