BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFESTENT FLEXSTAR XL VASCULAR STENT SYSTEM

    MDR report key: 1931609 · Received December 10, 2010

    Report

    Report Number
    9681442-2010-00116
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    November 18, 2010
    Report Date
    November 18, 2010
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK
    Product Code
    NIP
    PMA / PMN Number
    P070014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTEDLY THREE STENTS WERE IMPLANTED, A 7X60MM, A 7X170MM AND A 7X150MM, THE INFORMATION AVAILABLE INDICATES THAT ONE OF THE LONG STENTS (LONGER THAN 100MM) WAS FRACTURED; HOWEVER, IT IS NOT KNOWN WHICH OF THE TWO LONG STENTS WAS INVOLVED. THEREFORE, THE LOT HISTORY RECORDS, FOR BOTH LOTS HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THIS PRODUCT AND THE PRODUCT WAS FOUND TO HAVE MEET ALL SPECIFICATIONS PRIOR TO SHIPMENT. THE EVENT INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO WEEKS POST-IMPLANT, A VASCULAR STENT APPEARED TO BE FRACTURED. REPORTEDLY, THE PATIENT PRESENTED WITH LEFT LEG PAIN AND HAD DEEP VEIN THROMBOSIS. THREE OVERLAPPING STENTS WERE PREVIOUSLY PLACED FROM THE SFA TO THE DISTAL POPLITEAL ARTERY; TWO LONGER AND ONE SHORTER STENT. ANGIOGRAPHY DEMONSTRATED THAT THE LEG WAS THROMBOSED AND ONE OF THE TWO LONGER OVERLAPPING STENTS IN THE LEFT SUPERFICIAL ARTERY (SFA) APPEARED TO BE FRACTURED. A LASER ATHERECTOMY WAS PERFORMED WITHIN THE SFA AND WITHIN THE STENTS. ASPIRATION THROMBECTOMY WAS SUCCESSFUL, REMOVING A LARGE AMOUNT OF CLOT. FOLLOWING DILATION, ANOTHER STENT (6X80) WAS IMPLANTED WITHIN THE FRACTURED STENT. FINAL ANGIOGRAMS REPORTEDLY DEMONSTRATED GOOD RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention MFG DATE: 0/22/2010,| MFG DATE: 03/10/2010| EXP DATE: 02/2011| EXP DATE: 03/2011| CATALOG #: EX071503CSM, LOT# ANUB1908| CATALOG #: EX071703CS, LOT#: ANUC0498