BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 4233658 · Received November 6, 2014

    Report

    Report Number
    2029214-2014-00620
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    October 7, 2014
    Report Date
    October 8, 2014
    Manufacturer
    COVIDIEN
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 WIDE NECK ANEURYSM MEASURING 10MM LOCATED IN THE P-COMM (POSTERIOR COMMUNICATING) ARTERY. FETAL TYPE RIGHT P1 SEGMENT. THE PATIENT WAS SENSITIVE TO ASPIRIN AND CLOPIDOGREL PRIOR TO AND POST PROCEDURE. THE PATIENT UNDERWENT PIPELINE (4.50MM X 25MM) EMBOLIZATION TREATMENT ON AN UNSPECIFIED DATE WITHOUT ISSUES. POST PIPELINE PROCEDURE ((B)(6) 2014), THE PATIENT EXPERIENCED LEFT SIDE WEAKNESS WHICH WAS BELIEVED TO BE CAUSED BY THE DEPLOYMENT OF THE PIPELINE ACROSS THE CAROTID TERMINUS (M1 TO CAROTID), WATERSHED TERRITORY INFARCT AND EMBOLI, AND TORTUOSITY OF THE ARCH. THE PATIENT WENT THROUGH ACUTE REHAB AND WAS DISCHARGED TO A NURSING HOME. THE PATIENT¿S CONDITION IMPROVED, BUT THERE WAS STILL WEAKNESS ON THE LEFT SIDE. THE PATIENT WAS TRANSITIONING HOME DUE TO DEPRESSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714431 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT COVIDIEN FA-71450-25 9944472

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Disability