BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 2950739 · Received February 8, 2013

    Report

    Report Number
    2029214-2013-00109
    Event Type
    Injury
    Date Received
    February 8, 2013
    Date of Event
    October 19, 2012
    Report Date
    January 22, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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.THE OTHER DEVICES INVOLVED IN THE EVENT ARE AS FOLLOWS:MODEL: FA-77450-12 / LOT: NOT REPORTED / DOM: N/A / EXP: N/A.MODEL: FA-77350-16 / LOT: NOT REPORTED / DOM: N/A / EXP: N/A.(B)(4).

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE (B)(6) CLINICAL DATABASE. TREATMENT OF THREE RIGHT UNRUPTURED ICA (INTERNAL CAROTID ARTERY) ANEURYSMS MEASURING 3.6MM X 2.4MM, 4.8MM X 4.2MM, AND 7.4MM X 4MM. IT WAS REPORTED THAT THE PATIENT UNDERWENT PIPELINE EMBOLIZATION ON (B)(6) 2011 IN WHICH THREE PIPELINES WERE IMPLANTED. UPON FOLLOW-UP ON (B)(6) 2012, THE PATIENT HAD LEFT HEMIPARESIA, LEFT FACIAL DROOP, AND LEFT HEMIANOPSIA. ANOTHER FOLLOW-UP ON (B)(6) 2012 SHOWED THE PATIENT'S LEFT HEMIPARESI AND LEFT FACIAL DROOP HAD IMPROVED; HOWEVER, THE LEFT HEMIANOPSIA REMAINED THE SAME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54908 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77350-20 NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Disability