BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 4905722 · Received July 6, 2015

    Report

    Report Number
    MW5043906
    Event Type
    Death
    Date Received
    July 6, 2015
    Date of Event
    June 24, 2015
    Report Date
    July 6, 2015
    Manufacturer
    COVIDIEN/MEDTRONIC
    Product Code
    OUT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT WITH RIGHT VERTEBRAL ARTERY ANEURYSM THAT HAS GROWN SINCE 2010. ELECTIVE PROCEDURE PLANNED FOR (B)(6) 2015 PIPELINE FLOW-DIVERTER. PATIENT ADMITTED ON (B)(6) FOR PIPELINE DEVICE PLACEMENT. THE DEVICE FAILED TO OPEN DURING THE PROCEDURE. HEPARIN WAS STARTED IN ORDER TO KEEP THE DEVICE PATENT. PATIENT STARTED HAVING EPISTAXIS AND NASAL PACKS WERE PLACED. PATIENT RETURNED TO OPERATING ROOM TO ATTEMPT RETRIEVAL OF THE PIPELINE DEVICE ON (B)(6) AND WAS UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436086 PIPELINE EMBOLIZATION DEVICE PIPELINE DEVICE OUT COVIDIEN/MEDTRONIC FA-77500-16 A041511

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death