BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 3824766 · Received May 21, 2014

    Report

    Report Number
    2029214-2014-00290
    Event Type
    Death
    Date Received
    May 21, 2014
    Date of Event
    May 3, 2014
    Report Date
    May 7, 2014
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 LARGE UNRUPTURED SACCULAR ANEURYSM MEASURING 13MM X 7MM LOCATED IN THE OPHTHALMIC SEGMENT OF THE RIGHT ICA (INTERNAL CAROTID ARTERY). THE PATIENT WAS GIVEN DUAL ANTI-PLATELET THERAPY. ON (B)(6) 2014, THE PATIENT UNDERWENT PIPELINE (4.25MM X 18MM) EMBOLIZATION TREATMENT WITHOUT ISSUES. THE PATIENT'S PLATELET REACTIVITY AT THE TIME OF THE PROCEDURE WAS ABOUT 60 PERCENT. POST PROCEDURAL ANGIOGRAM SHOWED AN ECLIPSE. THE PATIENT WAS DISCHARGED HOME WITHOUT ISSUES. TWO DAYS POST PROCEDURE (B)(6) 2014, THE PATIENT'S PLATELET REACTIVITY WAS 100 PERCENT INHIBITED. THE PATIENT EXPERIENCED AN INTRAPARENCHYMAL HEMORRHAGE AND EXPIRED (DATE UNKNOWN). THE CAUSALITY WAS UNKNOWN. THE PHYSICIAN WAS UNWILLING TO GIVE ANY FURTHER INFORMATION REGARDING THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301626 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77425-18 9902803

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death