BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 2744087 · Received September 13, 2012

    Report

    Report Number
    2029214-2012-00475
    Event Type
    Injury
    Date Received
    September 13, 2012
    Date of Event
    December 12, 2011
    Report Date
    August 16, 2012
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES WILL NOT BE RETURNED FOR EVALUATION AS THEY WERE IMPLANTED IN THE PATIENT. MODEL# AND LOT# OF OTHER INVOLVED PIPELINES: MODEL: FA-71450-35; LOT: 9497394; DOM: 10/04/2001; EXP: 01/31/2014. MODEL: FA-71450-35, LOT: JA11-043 - DOM: 01/27/2011; EXP: 01/31/2014. MODEL: FA-77500-20, LOT: OC11-048 - DOM: 10/24/2011; EXP: 10/24/2014. MODEL: FA-71500-30, LOT: AU11-084 - DOM: 08/26/2011; EXP: 08/26/2014. MODEL: FA-71500-35, LOT: NV11-007 - DOM: 11/03/2011; EXP: 11/03/2014. (B)(4).

    Description of Event or Problem · 1

    TREATMENT OF A LEFT CAVERNOUS ICA ANEURYSM. IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH 6 PIPELINES AND A BALLOON WAS USED TO ENSURE THE CENTER OF CONSTRUCT OPEN. TWO DAYS POST PROCEDURE, THE PATIENT EXPERIENCED INTRAPARENCHYMAL HEMORRHAGE. THE PATIENT WAS PLACED ON PRASAGREL AND DISCHARGED UPON IMPROVING CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77475-20 AU11-034

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability