BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 2972638 · Received February 21, 2013

    Report

    Report Number
    2029214-2013-00126
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    December 10, 2011
    Report Date
    January 29, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    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 HAS NOT BEEN RETURNED FOR EVALUATION.(B)(4).

    Description of Event or Problem · 1

    TREATMENT OF A LEFT UNRUPTURED OPHTHALMIC ICA (INTERNAL CAROTID ARTERY) SIDEWALL ANEURYSM MEASURING 16.4MM X 4.4MM. FOUR DAYS POST PIPELINE PROCEDURE, IT WAS REPORTED THAT THE PATIENT BEGAN TO LOSE VISION IN HER LEFT EYE WHICH PROGRESSED TO BLINDNESS. IMAGING ON THE PATIENT SHOWED AN IN-STENT STENOSIS AND A PATENT OPHTHALMIC ARTERY.IT WAS REPORTED THAT THE PATIENT STILL HAD BLINDNESS IN HER LEFT EYE PER FOLLOW-UP ON (B)(6) 2012 AND HER CONDITION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77175 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77450-16 NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Disability