BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESTENT FLEXSTAR VASCULAR STENT SYSTEM

    MDR report key: 1974735 · Received December 28, 2010

    Report

    Report Number
    9681442-2010-00119
    Event Type
    Malfunction
    Date Received
    December 28, 2010
    Date of Event
    November 10, 2010
    Report Date
    December 2, 2010
    Manufacturer
    ANGIOMED GMBH & CO., MEDIZINTECHNIK
    Product Code
    NIP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED FOR EVALUATION. THE EVENT INVESTIGATION IS CURRENTLY UNDERWAY. THIS EVENT IS BEING REPORTED BECAUSE, THIS DEVICE IS THE SAME OR SIMILAR TO ONE MARKETED IN THE UNITED STATES. PMA#: P070014.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER RELEASE, "THE STENT DID NOT OPEN COMPLETELY AND REMAINED ADHERENT TO THE WIDTH". THE STENT WAS PARTIALLY TORN. THE PHYSICIAN PLACED A SECOND STENT. THERE WAS NO CLINICAL CONSEQUENCE FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESTENT FLEXSTAR VASCULAR STENT SYSTEM NIP ANGIOMED GMBH & CO., MEDIZINTECHNIK ANUE0570

    Patients

    Seq Age Sex Outcome Treatment
    1