BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 4232435 · Received November 6, 2014

    Report

    Report Number
    2029214-2014-00610
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    October 7, 2014
    Report Date
    October 7, 2014
    Manufacturer
    COVIDIEN
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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

    THE PATIENT PRESENTED WITH A RUPTURED PERI-OPHTHALMIC ANEURYSM AND SAH (SUBARACHNOID HEMORRHAGE). ON THE FOLLOWING DAY ((B)(6) 2014), THE PATIENT UNDERWENT PIPELINE EMBOLIZATION TREATMENT. DURING THE PROCEDURE, IT WAS REPORTED THE PIPELINE (3.75MM X 14MM) WAS DELIVERED WITHOUT ISSUES; HOWEVER, THE PROXIMAL END OF THE PIPELINE APPEARED TO BE VERY SLIGHTLY NARROWED. A HYPERFORM BALLOON WAS PREPARED TO ANGIOPLASTY (AN OPTION PRESENTED IN THE INSTRUCTIONS FOR USE, U.S.) THE PROXIMAL PIPELINE OPEN AND IT WAS DISCOVERED THAT THE PIPELINE HAD DEVELOPED SMALL CLOT PARTICLES DURING THIS TIME. THE BALLOON WAS THEN ADVANCED AND THE PROXIMAL END OF THE PIPELINE WAS ANGIOPLASTIED TO ACHIEVE FULL WALL APPOSITION AND GAIN BETTER POSITION. AGRISTAT WAS ADMINISTERED AND 20 MINUTES WAS ALLOWED TO ELAPSE TO GIVE TIME FOR THE CLOT TO RESOLVE. ON THE FOLLOWING DAY, THE PATIENT WAS REPORTED TO BE DOING FINE WITHOUT RESIDUAL EFFECTS OF THE CLOT. THE PATIENT WAS REPORTED TO BE STILL IN THE HOSPITAL THE FOLLOWING MORNING WHICH WAS NORMAL FOLLOWING A SUBARACHNOID HEMORRHAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715348 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT COVIDIEN FA-77375-14 9939295

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention