BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 4232417 · Received November 6, 2014

    Report

    Report Number
    2029214-2014-00609
    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
    MI, US
    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 LARGE UNRUPTURED SACCULAR ANEURYSM MEASURING 17MM X 6MM LOCATED IN THE CAVERNOUS SEGMENT OF THE RIGHT ICA (INTERNAL CAROTID ARTERY). THE PATIENT WAS ON DUAL ANTIPLATELET THERAPY. ON (B)(6) 2014, THE PATIENT UNDERWENT PIPELINE EMBOLIZATION TREATMENT. DURING THE PROCEDURE, IT WAS REPORTED THE PIPELINE (4.25MM X 35MM) DID NOT OPEN IN THE MIDDLE AND REQUIRED BALLOON ANGIOPLASTY (AN OPTION PRESENTED IN THE INSTRUCTIONS FOR USE, U.S.) WITH A HYPERFORM BALLOON TO ACHIEVE FULL WALL APPOSITION. POST PROCEDURAL ANGIOGRAM SHOWED AN ECLIPSE. THE PATIENT WAS DISCHARGED THE NEXT DAY AND WAS DOING WELL. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715318 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT COVIDIEN FA-71425-35 9625172

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention