BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 3525799 · Received December 18, 2013

    Report

    Report Number
    2029214-2013-00991
    Event Type
    Death
    Date Received
    December 18, 2013
    Report Date
    November 19, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    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 DEVICES INVOLVED IN THE EVENT ARE AS FOLLOWS: MODEL#: FA-71500-35; LOT#: NOT REPORTED DOM: N/A EXP: N/A (QTY. 2). (B)(4).

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM ARTICLE JOURNAL OF NEUROSURGERY JUN 2012 / VOL. 116 / NO. 6 / PAGES 1258-1266 "PANACEA OR PROBLEM: FLOW DIVERTERS IN THE TREATMENT OF SYMPTOMATIC LARGE OR GIANT FUSIFORM VERTEBROBASILAR ANEURYSMS." A RETROSPECTIVE REVIEW WAS PERFORMED ON THE PROSPECTIVE ENDOVASCULAR DATABASE AT MILLARD FILLMORE GATES CIRCLE HOSPITAL AND IT WAS DETERMINED THAT 25 PATIENTS HAD BEEN TREATED TO DATE WITH THE PIPELINE EMBOLIZATION DEVICE, EITHER AS A PART OF THE PIPELINE FOR UNCOILABLE OR FAILED ANEURYSMS STUDY OR SUBSEQUENT TO FDA APPROVAL OF THIS DEVICE. ALL OF THE PATIENTS WERE ROUTINELY PLACED ON ASPIRIN AND CLOPIDOGREL PRIOR TO THE PIPELINE PLACEMENT. RESPONSE TESTING TO BOTH MEDICATIONS WAS ALSO PERFORMED. AMONG THE 25 PATIENTS TREATED WITH PIPELINE, 6 PATIENTS HAD FUSIFORM VERTEBROBASILAR ANEURYSMS. OUT OF THESE 6 PATIENTS, 5 OF THEM HAD COMPLICATIONS. TREATMENT OF A GIANT FUSIFORM HOLOBASILAR ANEURYSM MEASURING 8.5MM X 56MM LOCATED IN THE PONS REGION. THE PATIENT PRESENTED WITH DYSARTHRIA, DYSPHAGIA, AND SEVERE LEFT HEMIPARESIS. THE MRS (MODIFIED RANKIN SCALE) 4 = (MODERATELY SEVERE DISABILITY, UNABLE TO ATTEND TO OWN BODILY NEEDS WITHOUT ASSISTANCE, AND UNABLE TO WALK UNASSISTED). THE PATIENT UNDERWENT EMBOLIZATION TREATMENT WITH THREE PIPELINES (5.00MM X 35MM, QTY. 2; 5.00MM X 30MM, QTY. 1) USING THE OVERLAPPING METHOD AND COILS. THE PATIENT WAS THEN TRANSFERRED TO A HOSPICE FACILITY. THE PATIENT'S CONDITION DID NOT IMPROVE TWO WEEKS POST PROCEDURE AND SUBSEQUENTLY THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661272 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-71500-30 NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death