BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESTENT VASCULAR STENT

    MDR report key: 3801888 · Received February 11, 2014

    Report

    Report Number
    9681442-2014-00026
    Event Type
    Malfunction
    Date Received
    February 11, 2014
    Date of Event
    January 2, 2014
    Report Date
    January 15, 2014
    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 21 CFR 803 AS IT INVOLVES A SIMILAR DEVICE TO A PMA APPROVED DEVICE SOLD IN THE U.S. UNDER NUMBER 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 AFTER DEPLOYMENT OF THE VASCULAR STENT, DURING REMOVAL OF THE DELIVERY SYSTEM THE USER NOTICED THAT THE DISTAL PART OF THE DELIVERY SYSTEM HAD DETACHED. THE FRAGMENT REMAINS IN THE LOW POPLITEAL ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90056 LIFESTENT VASCULAR STENT VASCULAR STENT NIP ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANXJ0248

    Patients

    Seq Age Sex Outcome Treatment
    1