BEUDAMED
    FDA Adverse Event Death Summary report: N

    STARCLOSE SE VASCULAR CLOSURE SYSTEM

    MDR report key: 2011256 · Received March 8, 2011

    Report

    Report Number
    2024168-2011-01535
    Event Type
    Death
    Date Received
    March 8, 2011
    Date of Event
    February 7, 2011
    Report Date
    February 11, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P050007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS NOT PROVIDED, THEREFORE, REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE STARCLOSE SE ACHIEVED ARTERIOTOMY CLOSURE OF THE COMMON FEMORAL ARTERY AFTER AN ENDOVASCULAR ANEURYSM COILING PROCEDURE. REPORTEDLY, NOT LONG AFTER UNEVENTFUL ARTERIOTOMY CLOSURE, THE PATIENT BECAME HYPOTENSIVE. IT WAS DETERMINED THE PATIENT DEVELOPED A RETROPERITONEAL BLEED. TREATMENT WAS NOT SPECIFIED. AN UNSPECIFIED TIME LATER, THE PATIENT EXPIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STARCLOSE SE VASCULAR CLOSURE SYSTEM IMPLANTABLE CLIP MGB AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death