BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFESTENT SOL OVASCULAR STENT SYSTEM

    MDR report key: 4142574 · Received September 30, 2014

    Report

    Report Number
    9681442-2014-00128
    Event Type
    Injury
    Date Received
    September 30, 2014
    Date of Event
    April 9, 2014
    Report Date
    September 4, 2014
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    NIP
    PMA / PMN Number
    P070014/S046
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS REPORTED TO THE FDA VIA VOLUNTARY USER FACILITY MEDWATCH #(B)(4). THE LOT HISTORY RECORDS HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MFG AND INSPECTION OF THIS PRODUCT AND THE PRODUCT WAS FOUND TO HAVE MET ALL SPECS PRIOR TO SHIPMENT. AS PART OF ALL COMPLAINT INVESTIGATIONS, AN ATTEMPT WAS MADE TO EVALUATE THE SUBJECT DEVICE AS WELL AS THE DEVICE USAGE. IN THIS CASE, NO SAMPLE AND NO IMAGES WERE PROVIDED. THEREFORE, THE ALLEGED STENT FRACTURE COULD NOT BE CONFIRMED. POTENTIAL FACTORS THAT COULD HAVE LED OR CONTRIBUTED TO THE REPORTED EVENT HAVE BEEN CONSIDERED. PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS HAVE BEEN REVIEWED. AN INADVERTENT MOVEMENT OF THE HAND OR INCORRECT HOLDING OF THE DELIVERY SYSTEM DURING STENT RELEASE, AN INSUFFICIENT PRE OR POST DILATION, HIGHLY CALCIFIED VESSELS, THE PT'S CONDITION OR THE VESSEL ANATOMY MAY RESULT IN AN IRREGULAR STENT PLACEMENT AND SUBSEQUENT STENT FRACTURE. IN THIS CASE, ONLY LIMITED INFO WAS PROVIDED. ON THE BASIS OF THE INFO AVAILABLE, A DEFINITE ROOT CAUSE FOR THE REPORTED EVENT REPORTED COULD NOT BE DETERMINED. THE IFU SUPPLIED WITH THIS DEVICE STATES THAT STENT FRACTURE IS A POTENTIAL ADVERSE EVENT THAT MAY OCCUR. FURTHERMORE, THE IFU SUFFICIENTLY DESCRIBED THE CORRECT APPLICATION OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REOIRTED THAT APPROX 11 MONTHS POST IMPLANTATION OF THE VASCULAR STENT IN THE SFA, A STENT FRACTURE WAS IDENTIFIED. THE FRACTURE WAS REPAIRED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608126 LIFESTENT SOL OVASCULAR STENT SYSTEM NIP ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANWL2439

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention