BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 3983075 · Received August 6, 2014

    Report

    Report Number
    2029214-2014-00450
    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. TEN PATIENTS WITH LARGE OR GIANT COMPLEX VERTEBROBASILAR JUNCTION ANEURYSMS WERE TREATED WITH FDS (FLOW DIVERTING STENTS). NINE 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 5: TREATMENT OF A GIANT FUSIFORM ANEURYSM. THE PATIENT WAS PLACED ON ASPIRIN 100 MG/D PLUS CLOPIDOGREL 75 TO 150 MG/D FOR 3 TO 7 DAYS BEFORE THE TREATMENT. THREE MONTHS PRIOR TO THE FDS PROCEDURE, AN INITIAL ATTEMPT OF STENT ASSISTED COILING EMBOLIZATION WITH DETACHMENT OF 1 SOLITAIRE STENT HAD FAILED. THE PATIENT UNDERWENT FDS EMBOLIZATION TREATMENT ON AN UNSPECIFIED DATE. DURING THE PROCEDURE, A TOTAL OF 9 PEDS WERE IMPLANTED IN THE PATIENT OVERLAPPING EACH OTHER WITHOUT ISSUES. DUAL ANTIPLATELET THERAPY WITH CLOPIDOGREL (75-150 MG/D) AND ASPIRIN (81-325 MG/D) WAS CONTINUED. A DOUBLE DOSE OF CLOPIDOGREL (150 MG/D) WAS INITIATED AS A RESULT OF LOW RESPONSE TESTING. ELEVEN MONTHS POST PROCEDURE, ANGIOGRAPHY REVEALED MINIMAL RESIDUAL FILLING AND A DELAYED IN-STENT THROMBOSIS OCCURRED IN THE GIANT FUSIFORM ANEURYSM. TWO WEEKS PRIOR TO THIS, CONTROL DSA (DIGITAL SUBTRACTION ANGIOGRAPHY) REVEALED A LARGELY THROMBOSED ANEURYSM WITH MINIMAL RESIDUAL INFLOW AND CLOPIDOGREL HAD BEEN DISCONTINUED. THE PATIENT ULTIMATELY EXPIRED DUE TO LARGE POSTERIOR CIRCULATION INFARCTS DESPITE SUCCESSFUL INTRAVENOUS (EPTIFIBATIDE), INTRA-ARTERIAL (RECOMBINANT TISSUE-TYPE PLASMINOGEN ACTIVATOR) THROMBOLYSIS, MECHANICAL THROMBECTOMY AND SURGICAL POSTERIOR FOSSA DECOMPRESSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461589 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR NOT REPORTED NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Death