BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 3000499 · Received March 12, 2013

    Report

    Report Number
    2029214-2013-00225
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    January 25, 2013
    Report Date
    February 12, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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

    TREATMENT OF AN ANEURYSM. DURING PIPELINE DEPLOYMENT, IT WAS REPORTED THAT THE PHYSICIAN HAD A DIFFICULT TIME OPENING THE PIPELINE AND RELEASING IT FROM THE CAPTURE COIL. THE PIPELINE DID NOT FULLY COVER THE ANEURYSM NECK AFTER IT WAS DEPLOYED; THEREFORE, ANOTHER PIPELINE WAS DEPLOYED FOR FULL COVERAGE. NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103855 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77425-18 9434292

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability