BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 3940924 · Received July 17, 2014

    Report

    Report Number
    2029214-2014-00409
    Event Type
    Death
    Date Received
    July 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    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

    INFORMATION RECEIVED FROM THE ARTICLE: MONTEITH SJ, M.D., TSIMPAS A, M.D., M.SC., DUMONT AS, MD., ET AL. ENDOVASCULAR TREATMENT OF FUSIFORM CEREBRAL ANEURYSMS WITH THE PIPELINE EMBOLIZATION DEVICE. J NEUROSURG 120. 2014:945-954. A TOTAL OF 146 PATIENT WERE TREATED WITH PIPELINE EMBOLIZATION DEVICE (PED). 24 OF THE 144 WERE IDENTIFIED AS HAVING FUSIFORM ANEURYSMS (9 MEN AND 15 WOMEN) WITH A MEAN AGE OF 59 YEARS. ALL THE PATIENTS WERE GIVEN ANTI-PLATELET THERAPY. 23 OF THE 24 HAD NO PROCEDURAL COMPLICATIONS. ONE HAD A GROIN PSEUDOANEURYSM THAT WAS MANAGED CONSERVATIVELY. 4 OF THE 24 HAD MAJOR COMPLICATIONS RELATED TO THE ANEURYSM TREATMENT AND THERE WAS ONE DEATH. CASE (B)(4): TREATMENT OF A LARGE ANEURYSM MEASURING 22MM X 23MM X 20MM LOCATED IN THE BASILAR TRUNK. THE PATIENT PRESENTED WITH ATAXIA AND CRANIAL NERVE PALSY VI UNDERWENT PIPELINE (5MM X 30MM) EMBOLIZATION TREATMENT INVOLVING ONE PIPELINE WITHOUT ISSUES. THE PATIENT HAD A VP SHUNT PLACED IN PREPARATION FOR THE PREDICTED SWELLING AND AQUEDUCTAL CLOSURE RESULTING FROM THE ANEURYSM THROMBOSIS. THE PATIENT DID WELL. 7 MONTHS POST PROCEDURE, THE PATIENT SUFFERED A SUBARACHNOID HEMORRHAGE AND CARE WAS WITHDRAWN BY THE FAMILY AND HE SUBSEQUENTLY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420150 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-71500-30 NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death