BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 2981277 · Received February 27, 2013

    Report

    Report Number
    2029214-2013-00172
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    July 29, 2009
    Report Date
    February 19, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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

    INFORMATION RECEIVED FROM THE INTREPED CLINICAL DATABASE. TREATMENT OF A RIGHT UNRUPTURED ICA (INTERNAL CAROTID ARTERY) / OTHER PARAOPHTHALMIC ANEURYSM MEASURING 11.7MM X 5.0MM. IT WAS REPORTED THAT THE PATIENT UNDERWENT PIPELINE EMBOLIZATION TREATMENT ON 07/21/2009 AND HER VISUAL ACUITY DECREASED ON (B)(6) 2009. IT WAS REPORTED THAT THE PATIENT'S CONDITION RESOLVED ON (B)(6) 2010. WITH STEROID MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83990 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77375-18 NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Disability