BEUDAMED
    FDA Adverse Event Other Summary report: N

    STARCLOSE

    MDR report key: 855112 · Received May 18, 2007

    Report

    Report Number
    MW5001936
    Event Type
    Other
    Date Received
    May 18, 2007
    Date of Event
    September 19, 2006
    Report Date
    May 18, 2007
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A LADY WHO HAS A HISTORY OF PERIPHERAL VASCULAR DISEASE. SHE HAD A PERCUTANEOUS INTERVENTION DONE ON HER LEFT SUPERFICIAL FEMORAL ARTERY VIA THE RIGHT GROIN IN 2006. AFTER SUCCESSFUL COMPLETION OF HER PROCEDURE, A SELECTIVE RIGHT FEMORAL ANGIOGRAM CONFIRMED THAT THE ARTERY WAS FREE OF ANY SIGNIFICANT DISEASE. THEREFORE, A STARCLOSE DEVICE WAS USED TO CLOSE THE RIGHT FEMORAL ARTERY ACCESS SITE. DEVICE WAS UNSUCCESSFUL WITH DEVELOPMENT OF A HEMATOME WHICH REQUIRED COMPRESSION WITH FEMSTOP TO ACHIEVE HEMOSTASIS. SUBSEQUENT FOLLOW UP ARTERIAL DUPLEX SCAN SHOWED A SEVERE STENOSIS IN THE RIGHT FEMORAL ARTERY AT THE SITE OF CLOSURE WITH THE DEVICE WITH A PEAK SYSTOLIC VELOCITY OF 531 CM/SEC WITH ABNORMAL ABI. A SELECTIVE ANGIOGRAM DONE IN 2007, SHOWED A SEVERE GREATER THAN 80% STENOSIS AT THE SITE OF THE STARCLOSE DEVICE IMPLANT. SHE CURRENTLY HAS SIGNIFICANT CLAUDICATION TO HER RIGHT LOWER EXTREMITY DUE TO THIS AND IS BEING CONSIDERED FOR SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE STARCLOSE MGB ABBOTT VASCULAR M13614677010

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other