BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESTENT FLEXSTAR VASCULAR STENT SYSTEM

    MDR report key: 2142540 · Received June 20, 2011

    Report

    Report Number
    9681442-2011-00034
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    May 25, 2011
    Report Date
    May 25, 2011
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK
    Product Code
    NIP
    PMA / PMN Number
    P070014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THE DEVICE IS UNK. THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. THE STENT REMAINS IMPLANTED. THE DELIVERY SYS HAS NOT BEEN RETURNED TO THE MFR FOR EVAL TO DATE. THIS EVENT IS BEING REPORTED BECAUSE THIS DEVICE IS THE SAME OR SIMILAR TO ONE MARKETED IN THE UNITED STATES PMA # (B)(4). THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER SUCCESSFUL DEPLOYMENT IN THE PROXIMAL POPLITEAL ARTERY, DURING RETRACTION FROM THE 6F INTRODUCER SHEATH, THE DISTAL PORTION OF THE DELIVERY SYS DETACHED FROM THE REST OF THE CATHETER. REPORTEDLY, THE DETACHED PORTION WAS OBSERVED TO BE PARTIALLY OUTSIDE OF THE SHEATH, BUT STILL LOADED OVER THE .035 INCH GUIDEWIRE. THE PHYSICIAN WAS ABLE TO REMOVE THE ENTIRE DELIVERY SYSTEM FROM THE INTRODUCER SHEATH WITHOUT FURTHER INCIDENT. FINAL ANGIOGRAPHY DEMONSTRATED SUITABLE PATENCY RESULTS OF THE TREATMENT SITE. IMAGES ARE NOT AVAILABLE. NO REPORT OF PT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1