BEUDAMED
    FDA Adverse Event Death Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 1790924 · Received July 30, 2010

    Report

    Report Number
    2953144-2010-01532
    Event Type
    Death
    Date Received
    July 30, 2010
    Date of Event
    January 1, 2010
    Report Date
    July 6, 2010
    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
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED, THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT IDENTIFIED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    DEVICE ISSUE: DID NOT FUNCTION AS EXPECTED - CLIP. TIME OF DEVICE ISSUE: DURING VESSEL CLOSURE. ADVERSE EVENT: FAILURE TO ACHIEVE HEMOSTASIS, BRUISING, PSEUDOANEURYSM, PULMONARY EMBOLISM, DEATH. IT WAS REPORTED THA A PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE SE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF THE RIGHT FEMORAL ARTERY AFTER A DIAGNOSTIC PROCEDURE. REPORTEDLY, THE DEVICE DID NOT DEPLOY ADEQUATELY AND IT WAS BELIEVED THAT THE CLIP FAILED TO CATCH THE ARTERY. MANUAL COMPRESSION WAS APPLIED TO ACHIEVE HEMOSTASIS. THE PATIENT WAS DISCHARGED; HOWEVER, A FEW DAYS LATER RETURNED TO THE HOSPITAL WITH BRUISING THAT HAD DEVELOPED INTO A FALSE ANEURYSM. THIS WAS COMPRESSED, BUT A FEW HOURS LATER, THE PATIENT HAD A MASSIVE PULMONARY EMBOLISM (PE) AND EXPIRED. THE PHYSICIAN REPORTED THAT THE CAUSE OF DEATH WAS RELATED TO THE PE WHICH WAS SECONDARY TO A CARDIAC PROCEDURE AND BLEEDING AFTER THE FAILED CLOSER. ALTHOUGH, A COPY OF THE AUTOPSY REPORT WAS NOT PROVIDED, THE REPORT INDICATED THAT THE CAUSE OF DEATH WAS RELATED TO THE PE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death