BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESTENT LASCULAR STENT

    MDR report key: 3727351 · Received January 29, 2014

    Report

    Report Number
    9681442-2014-00019
    Event Type
    Malfunction
    Date Received
    January 29, 2014
    Date of Event
    December 10, 2013
    Report Date
    December 12, 2013
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    NIP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THIS PRODUCT IS NOT SOLD IN THE U.S., THIS EVENT IS BEING REPORTED UNDER REGULATION 21CFR PART 803 AS IT INVOLVES A SIMILAR DEVICE TO A PMA APPROVED DEVICE SOLD IN THE U.S. UNDER #P070014. THE LOT NUMBER HAS BEEN PROVIDED. THE DEVICE HISTORY RECORDS ARE BEING REVIEWED. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VASCULAR STENT COULD NOT BE DEPLOYED AND A PIECE OF THE HANDLE OF THE DELIVERY SYSTEM DETACHED. UPON RECEIPT OF THE COMPLAINT SAMPLE THE STENT WAS FOUND TO BE PARTIALLY RELEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63728 LIFESTENT LASCULAR STENT VASCULAR STENT NIP ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANX13374

    Patients

    Seq Age Sex Outcome Treatment
    1