BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 2992658 · Received March 7, 2013

    Report

    Report Number
    2029214-2013-00202
    Event Type
    Death
    Date Received
    March 7, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 6, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS IT WAS IMPLANTED IN THE PATIENT. (B)(4).

    Description of Event or Problem · 1

    TREATMENT OF A PARTIALLY THROMBOSED BA (BASILAR ARTERY) ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH HEADACHE AND PARTIALLY THROMBOSED BA ANEURYSM UNDERWENT PIPELINE EMBOLIZATION TREATMENT ON (B)(6) 2013. AFTER PIPELINE PLACEMENT, THE PHYSICIAN IMPLANTED 6 GDC COILS (MANUFACTURED BY BOSTON SCIENTIFIC) AND 6 TARGET COILS (MANUFACTURED BY STRYKER) TO FINISH FILLING THE ANEURYSM SAC. THE PATIENT DID NOT WAKE FROM THE GENERAL ANESTHESIA AND ENTERED INTO A COMA. DOUBLE ANTI-AGGREGATION THERAPY WAS DONE THROUGH A CATHETER AND IT PASSED THE LESION, PIPELINE, AND ANEURYSM NECK WITHOUT ANY PROBLEMS. SUBSEQUENTLY, THE PATIENT EXPIRED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97794 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-71325-25 MA11-041

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Death