BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 3070815 · Received April 22, 2013

    Report

    Report Number
    2029214-2013-00383
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    March 29, 2013
    Report Date
    March 29, 2013
    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 PUSHWIRES WERE RETURNED WITHOUT THE PIPELINES ATTACHED AND WITH NO DEFECTS; THEREFORE, THE EVENT CAUSES COULD NOT BE DETERMINED.(B)(4).

    Additional Manufacturer Narrative · 1

    THE PUSHWIRE INVOLVED IN THE EVENT HAS NOT BEEN RETURNED FOR EVALUATION.(B)(4).

    Description of Event or Problem · 1

    TREATMENT OF A LEFT UNRUPTURED CAV (CAVERNOUS) FUSIFORM ANEURYSM MEASURING 25MM X 35MM. DURING THE PIPELINE DEPLOYMENT, IT WAS REPORTED THAT THE PHYSICIAN NEEDED TO MANIPULATE THE MARKSMAN CATHETER IN ORDER TO RELEASE IT FROM THE CAPTURE COIL. NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173037 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-71500-35 9650469

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Disability