BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STARCLOSE VASCULAR CLOSURE SYSTEM

    MDR report key: 1161286 · Received September 15, 2008

    Report

    Report Number
    2953144-2008-01484
    Event Type
    Injury
    Date Received
    September 15, 2008
    Date of Event
    August 19, 2008
    Report Date
    August 20, 2008
    Manufacturer
    ABBOTT VASCULAR REDWOOD CITY
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. A POWER POINT SLIDE SET OF 5 ANGIOGRAM IMAGES WAS PROVIDED AND WERE REVIEWED BY ABBOTT VASCULAR IN-HOUSE MEDICAL MONITOR. BASED ON THE FINDINGS, THE IMAGES SHOW DIMINISHED FLOW AT THE LEVEL OF THE CLIP; HOWEVER, THE CAUSE CANNOT BE SEEN FROM THE IMAGES PROVIDED. THESE IMAGES DO NOT RULE OUT NOR CONFIRM THAT THE CLIP WAS ATTACHED TO THE ANTERIOR AND POSTERIOR ARTERY WALLS AND THE ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 1

    DEVICE ISSUE: CLIP MISLOCATION. TIME OF DEVICE ISSUE: DURING VESSEL CLOSURE. SYMPTOMS/AE: FAILURE TO ACHIEVE HEMOSTASIS, PSEUDOANEURYSM, ISCHEMIA, DISSECTION, ENDARTERECTOMY AND THROMBECTOMY. IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE RIGHT COMMON FEMORAL ARTERY (CFA) AFTER AN INTERVENTIONAL PROCEDURE. REPORTEDLY, ANGIOGRAPHY SHOWED A TIGHT "STENOSIS" IN THE DISTAL RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) UNDERLYING THE SITE OF THE STARCLOSE WITH PROBABLE DISSECTION. ADDITIONALLY, AN OCCLUDED MID-DISTAL POPLITEAL ARTERY WITH NO TIBIAL RUN OFF WAS FOUND CONSISTENT WITH ACUTE THROMBUS. THE PT WAS TAKEN TO SURGERY. REPORTEDLY, THE CLIP WAS FOUND ATTACHED TO THE ANTERIOR AND POSTERIOR WALL. THE PT EXHIBITED A COLD, PALE, PULSELESS RIGHT FOOT (ABSENT DORSALIS PEDIS AND POPLITEAL ARTERY PULSES.) A PSEUDOANEURYSM WAS FOUND AT THE RIGHT COMMON FEMORAL ARTERY. THROMBECTOMY WAS PERFORMED FOLLOWED BY A COMMON FEMORAL ENDARTERECTOMY AND VEIN GRAFT REPAIR. THERE WERE NO REPORTED ADVERSE PT SEQUELAE. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention