BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFESTENT SOLO VASCULAR STENT SYSTEM

    MDR report key: 3761004 · Received April 9, 2014

    Report

    Report Number
    9681442-2014-00061
    Event Type
    Injury
    Date Received
    April 9, 2014
    Date of Event
    March 4, 2014
    Report Date
    March 12, 2014
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    NIP
    PMA / PMN Number
    P070014/S042
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS REPORTED TO THE FDA VIA USER FACILITY MEDWATCH REPORT # (B)(4) DATED (B)(6), 2014. THE LOT HISTORY RECORDS HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THIS PRODUCT AND THE PRODUCT WAS FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. THERE IS NO INDICATION FOR A MANUFACTURING-RELATED FAILURE. 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 WAS RETURNED. ON THE BASIS OF THE IMAGES PROVIDED IT CAN BE CONFIRMED THAT THE STENT WAS TWISTED. DUE TO POOR CONTRAST AND IMAGE RESOLUTION, A STENT FRACTURE COULD NOT BE CONFIRMED. POTENTIAL FACTORS THAT COULD HAVE LED OR CONTRIBUTED TO THE REPORTED EVENT HAVE BEEN EVALUATED. PREVIOUS INVESTIGATIONS OF SIMILAR COMPLAINTS HAVE BEEN REVIEWED. A TWISTING OF THIS KIND OF STENT MAY BE CAUSED BY INTERACTIONS OF VARIOUS USE-RELATED AND ANATOMICAL FACTORS WITH THE GIVEN STENT DESIGN. THERE ARE ALSO VARIOUS PHYSICAL FORCES INCLUDING INDIVIDUAL PATIENT FACTORS THAT MAY CONTRIBUTE TO THE TWISTING OF A STENT IN THIS REGION. IN THIS CASE, NO ADD'L PROCEDURAL INFORMATION WAS PROVIDED. BASED ON THE INFO AVAILABLE, A DEFINITE ROOT CAUSE FOR THE EVENT REPORTED COULD NOT BE DETERMINED. THE IFU SUFFICIENTLY DESCRIBES THE CORRECT APPLICATION OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY THREE WEEKS POST IMPLANTATION OF THE VASCULAR STENT IN THE POPLITEAL ARTERY, IT WAS DISCOVERED THAT THE STENT WAS FRACTURED AND CONTAINED CLOT THAT WAS INHIBITING THE BLOOD FLOW. ANGIOPLASTY WAS PERFORMED AND A NEW VASCULAR STENT WAS PLACED ACROSS THE FRACTURED STENT SUCCESSFULLY. THERE IS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213305 LIFESTENT SOLO VASCULAR STENT SYSTEM NIP ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANXE2970

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention