BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 3033762 · Received April 3, 2013

    Report

    Report Number
    2029214-2013-00325
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 12, 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 WILL NOT BE RETURNED FOR EVALUATION. (B)(4).

    Description of Event or Problem · 1

    TREATMENT OF A LEFT CAV (CAVERNOUS) ANEURYSM MEASURING 28MM WITH A NECK OF 4MM. DURING PIPELINE DEPLOYMENT, IT WAS REPORTED THAT THE PROXIMAL END DID NOT OPEN AND WAS REMOVED FROM THE PATIENT WITH A SNARE. NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136614 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77475-16 9623921

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention| S