BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE VASCULAR CLOSURE SYSTEM

    MDR report key: 1202868 · Received October 17, 2008

    Report

    Report Number
    2953144-2008-01703
    Event Type
    Injury
    Date Received
    October 17, 2008
    Date of Event
    June 1, 2008
    Report Date
    September 24, 2008
    Manufacturer
    ABBOTT VASCULAR -VASCULAR SOLUTIONS
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT INVOLVES A CASE IN AN ARTICLE. THE DEVICE IS NOT AVAILABLE FOR ANALYSIS. THE LOT NUMBER WAS NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. THE STARCLOSE INSTRUCTIONS FOR USE (IFU) STATE: "THE STARCLOSE VASCULAR SYS IS INDICATED FOR THE PERCUTANEOUS DELIVER OF AN EXTRAVASCULAR CLIP FOR CLOSURE OF FEMORAL ARTERY ACCESS SITES FOLLOWING CATHETER-BASED PROCEDURES."

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: NONE. TIME OF SYMPTOMS/AE: AFTER VESSEL CLOSURE. SYMPTOMS/AE: POPLITEAL ARTERY OCCLUSION TREATED WITH BALLOON ANGIOPLASTY. THE FOLLOWING EVENT WAS NOTED THROUGH A PERIODIC ARTICLE REVIEW. A STUDY WAS CONDUCTED IN A TOTAL PTS TO EVALUATE THE SAFETY AND EFFICACY OF THE STARCLOSE CLIP DEVICE TO CLOSE POPLITEAL ARTERY PUNCTURES AFTER SUPERFICIAL FEMORAL ARTERY (SFA) RECANALIZATION. REPORTEDLY, THERE WAS ONLY ONE MAJOR COMPLICATION, A TRANSIENT POPLITEAL ARTERY OCCLUSION POSSIBLY INDUCED BY PLAQUE SHIFT DURING DEVICE REMOVAL OCCURRED IN A PREVIOUSLY UNDILATED, BUT DIFFUSELY DISEASED POPLITEAL ARTERY SEGMENT, WHICH WAS TREATED WITH BALLOON ANGIOPLASTY. THE ARTICLE STATES THAT THE ARTERIOTOMIES USING THE STARCLOSE DEVICE WERE PERFORMED OFF-LABEL DUE TO THE SFA'S BEING CHRONICALLY OCCLUDED AND MODERATELY TO SEVERELY CALCIFIED. NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE VASCULAR CLOSURE SYSTEM MGB ABBOTT VASCULAR -VASCULAR SOLUTIONS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention| S SHEATH: 1 X 7FR| HEPARIN