BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 2980163 · Received February 27, 2013

    Report

    Report Number
    2029214-2013-00161
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    September 17, 2011
    Report Date
    February 14, 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-77450-16 / LOT: NOT REPORTED / DOM: N/A / EXP: N/A; MODEL: FA-77500-14 / LOT: NOT REPORTED / DOM: N/A / EXP: N/A. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (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 10.8MM X 8.1MM. IT WAS REPORTED THAT THE PATIENT UNDER PIPELINE EMBOLIZATION TREATMENT ON (B)(6) 2011 INVOLVING THREE OVERLAPPING PIPELINES AND EXPERIENCED TEMPORARY VISION LOSS ON (B)(6) 2011. IT WAS REPORTED THAT THE PATIENT'S CONDITION RESOLVED ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85407 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77450-14 NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Disability