BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 3000540 · Received March 12, 2013

    Report

    Report Number
    2029214-2013-00221
    Event Type
    Death
    Date Received
    March 12, 2013
    Date of Event
    October 16, 2011
    Report Date
    February 18, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS THEY WERE IMPLANTED IN THE PATIENT.THE OTHER DEVICE INVOLVED IN THE EVENT IS AS FOLLOWS:MODEL: FA-71450-35 / LOT: NOT REPORTED / DOM: N/A / EXP: N/A.(B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4): IT WAS REPORTED THAT THE PATIENT HAD A MODERATE TIA (TRANSIENT ISCHEMIC ATTACK) ON (B)(6) 2011 THAT WAS UNLIKELY RELATED TO THE DEVICE. FOLLOWING THE PROCEDURE, THE PATIENT HAD HEMIPARESIS AND APHASIA WHICH ALREADY RESOLVED. THIS WAS PROBABLY DUE TO EDEMA. THE APHASIA SLIGHTLY IMPROVED ACCORDING TO THE FOLLOW-UP VISIT ON (B)(6) 2011. (B)(4).

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE (B)(6) CLINICAL DATABASE. TREATMENT OF A LEFT UNRUPTURED FUSIFORM MCA (MIDDLE CEREBRAL ARTERY) ANEURYSM MEASURING 55MM X 50MM. IT WAS REPORTED THAT THE PATIENT UNDERWENT PIPELINE EMBOLIZATION TREATMENT ON (B)(6) 2011 INVOLVING TWO TELESCOPING PIPELINES. THE PATIENT HAD A LEFT MCA TERRITORY ISCHEMIC STROKE 7 MONTHS AFTER THE PROCEDURE WHILE STILL ON ASA AND CLOPIDOGREL. SUBSEQUENTLY, THE PATIENT EXPIRED ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103367 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-71350-35 NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death