BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 3033017 · Received April 3, 2013

    Report

    Report Number
    2029214-2013-00315
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    September 13, 2011
    Report Date
    March 7, 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 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 (B)(6) CLINICAL DATABASE. TREATMENT OF A LEFT UNRUPTURED ICA (INTERNAL CAROTID ARTERY) SIDEWALL ANEURYSM MEASURING 11.87MM. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH RIGHT SIDED WEAKNESS, NUMBNESS, AND GAIT DIFFICULTY UNDERWENT PIPELINE EMBOLIZATION TREATMENT ON (B)(6) 2012. THE PATIENT EXPERIENCED WORSENED DIZZINESS SINCE BASELINE ON (B)(6) 2011. IT WAS REPORTED THAT THE RIGHT SIDED WEAKNESS, NUMBNESS, AND GAIT DIFFICULTY IMPROVED ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136006 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77350-20 NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Disability