BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 3983511 · Received August 6, 2014

    Report

    Report Number
    2029214-2014-00451
    Event Type
    Death
    Date Received
    August 6, 2014
    Report Date
    July 11, 2014
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 PIPELINE DEVICES INVOLVED IN THE EVENT ARE AS FOLLOWS: MODEL: NOT REPORTED / LOT: NOT REPORTED / DOM: N/A / EXP: N/A (QTY. UNKNOWN). (B)(4).

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE ARTICLE: MECKEL S, MCAULIFFE W, FIORELLA D, ET AL. ENDOVASCULAR TREATMENT OF COMPLEX ANEURYSMS AT THE VERTEBROBASILAR JUNCTION WITH FLOW DIVERTING STENTS: INITIAL EXPERIENCE. NEUROSURGERY. 2013 SEP;73(3):386-394. 10 PATIENTS WITH LARGE OR GIANT COMPLEX VERTEBROBASILAR JUNCTION ANEURYSMS WERE TREATED WITH FDS (FLOW DIVERTING STENTS). 9 PATIENTS WERE TREATED USING PED (PIPELINE EMBOLIZATION DEVICE) AND 1 PATIENT WAS TREATED WITH A SILK STENT. EACH PATIENT WAS PLACED ON ANTIPLATELET THERAPY ACCORDING TO EACH PHYSICIAN. OUT OF THE 10 PATIENTS TREATED WITH AN FDS, FOUR PATIENTS EXPIRED. CASE 4: TREATMENT OF A RUPTURED GIANT FUSIFORM DISSECTING ANEURYSM. THE PATIENT PRESENTED WITH AN SAH (SUBARACHNOID HEMORRHAGE) DUE TO A RUPTURED ANEURYSM. THE PATIENT WAS NOT PRELOADED WITH DAPT (DUAL ANTIPLATELET THERAPY); HOWEVER, THE PATIENT RECEIVED AN INTRAVENOUS BOLUS OF HEPARIN (5000 IU) AND ASPIRIN (500 MG) AT THE START OF THE PROCEDURE. AN EPTIFIBATIDE (GLYCOPROTEIN IIB/IIIA ANTAGONIST) INFUSION WAS INITIATED DURING THE PROCEDURE AND CONTINUED FOR 2 DAYS. THE PATIENT UNDERWENT FDS EMBOLIZATION TREATMENT ON AN UNSPECIFIED DATE. DURING THE PROCEDURE, NINE FDS DEVICES WERE IMPLANTED IN THE PATIENT OVERLAPPING EACH OTHER WITH A CONCOMITANT COILING PROCEDURE. THE POSTERIOR INFERIOR CEREBELLAR ARTERY ORIGIN WAS SECURED WITH A SOLITAIRE STENT. ANGIOGRAPHY REVEALED MINIMAL RESIDUAL FILLING. THE SAH RAISED INTRACRANIAL PRESSURE AND SUBSEQUENTLY THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459746 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR NOT REPORTED NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death