BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 4232982 · Received November 6, 2014

    Report

    Report Number
    2029214-2014-00621
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    October 8, 2014
    Report Date
    October 8, 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

    THE DEVICES INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS THEY WERE IMPLANTED IN THE PATIENT. (B)(4). THE OTHER DEVICE INVOLVED IN THE EVENT IS AS FOLLOWS: MODEL: FA-77500-14, LOT: 9944462, DOM: 30 APR 2012, EXP: 30 APR 2015.

    Description of Event or Problem · 1

    THE PATIENT PRESENTED WITH A RUPTURED RIGHT ICA (INTERNAL CAROTID ARTERY) ANEURYSM AND AN SA (SUBARACHNOID HEMORRHAGE). THE PATIENT WAS ON DUAL ANTIPLATELET THERAPY (ASPIRIN AND PLAVIX). ON THE FOLLOWING DAY ((B)(6) 2014), THE PATIENT UNDERWENT PIPELINE EMBOLIZATION TREATMENT INVOLVING TWO PIPELINES (4.25MM X 16MM / 5MM X 14MM). DURING POST PROCEDURAL ANGIOGRAPHY, IT WAS DISCOVERED THAT THE PIPELINES HAD DEVELOPED SMALL UNSPECIFIED CLOT PARTICLES DURING THIS TIME. IT WAS UNKNOWN WHAT THE CLOT WAS MADE OF. A BALLOON WAS THEN ADVANCED AND THE ENTIRE CONSTRUCT OF BOTH PIPELINES 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
    715742 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT COVIDIEN FA-77425-16 9952987

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention