BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 3872234 · Received June 13, 2014

    Report

    Report Number
    2029214-2014-00324
    Event Type
    Death
    Date Received
    June 13, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 20, 2014
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    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

    TREATMENT OF A SMALL UNRUPTURED ANEURYSM MEASURING APPROXIMATELY 4MM LOCATED IN THE OPHTHALMIC SEGMENT OF THE LEFT ICA (INTERNAL CAROTID ARTERY). ON (B)(6) 2014, THE PATIENT UNDERWENT PIPELINE (4.25MM X 12MM) EMBOLIZATION TREATMENT AND WAS DISCHARGED WITHOUT ISSUES. APPROXIMATELY FIVE DAYS AFTER THE PROCEDURE, THE PATIENT FELT ILL AND WENT TO THE ER (EMERGENCY ROOM). A CT (COMPUTED TOMOGRAPHY) SCAN WAS PERFORMED AND WAS NEGATIVE. ON (B)(6) 2014, THE PATIENT WENT BACK TO THE ER STILL FEELING ILL AND ANOTHER CT SCAN REVEALED A MASSIVE INTRAPARENCHYMAL AND INTRAVENTRICULAR HEMORRHAGE. THE PATIENT WAS TRANSFERRED TO (B)(6) AND ADMITTED IN THE ICU (INTENSIVE CARE UNIT). A VENTRICULAR DRAIN WAS PLACED IN THE PATIENT. THE PHYSICIAN SUSPECTS THE HEMORRHAGE MAY HAVE BEEN CAUSED BY ASPIRIN/PLAVIX. THE PRU (P2Y12 REACTION UNITS) WAS TESTED (ON AN UNSPECIFIED DATE) AND THE LEVELS WERE AT 110. ON (B)(6) 2014, THE PATIENT WAS REPORTED TO HAVE ENTERED A MEDICALLY-INDUCED COMA. ON (B)(6) 2014, IT WAS REPORTED THE PATIENT HAD EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350213 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77425-12 9670896

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death