BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 2860991 · Received December 6, 2012

    Report

    Report Number
    2029214-2012-00691
    Event Type
    Injury
    Date Received
    December 6, 2012
    Date of Event
    August 11, 2010
    Report Date
    November 8, 2012
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES WILL NOT BE RETURNED FOR EVALUATION AS THEY WERE IMPLANTED IN THE PATIENT.THE OTHER DEVICE INVOLVED IN THE EVENT WAS:MODEL#: FA-77325-12 / LOT#: NOT REPORTED / DOM: N/A / DOM: N/A.(B)(4).

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE (B)(6) CLINICAL DATABASE.TREATMENT OF A MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM. IT WAS REPORTED THAT THE PATIENT UNDERWENT PIPELINE EMBOLIZATION PROCEDURE IN 2010 AND SUBSEQUENTLY DEVELOPED RIGHT SIDED PARALYSIS AND DIFFICULTY WITH WORDS FROM AN ISCHEMIC STROKE. IT WAS REPORTED THE PATIENT'S CONDITION WAS RESOLVED ON (B)(6) 2010 WITH NO OTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77325-16 NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Disability