BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 3955916 · Received July 24, 2014

    Report

    Report Number
    2029214-2014-00423
    Event Type
    Injury
    Date Received
    July 24, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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 AN UNRUPTURED AMORPHOUS ANEURYSM LOCATED IN THE LEFT PCA (POSTERIOR CEREBRAL ARTERY). THE PATIENT WAS GIVEN DUAL ANTIPLATELET THERAPY. ON (B)(6) 2014, THE PATIENT UNDERWENT PIPELINE EMBOLIZATION TREATMENT. DURING THE PROCEDURE AFTER THE PIPELINE WAS DEPLOYED SUCCESSFULLY, IT WAS REPORTED THE PHYSICIAN NOTICED STAGNANT CONTRAST OUTSIDE OF THE VESSELS ON THE LAST RUN. THE ANEURYSM HAD RUPTURED AND A VENTRICULOSTOMY WAS PERFORMED ON THE PATIENT. THE AMOUNT OF BLOOD DRAINED WAS VERY SMALL. THE PHYSICIAN THINKS THAT THE SYNCHRO 2 WIRE MAY HAVE RUPTURED THE ANEURYSM UPON THE INITIAL ACCESS. POST PROCEDURAL ANGIOGRAM SHOWED AN ECLIPSE. THE PATIENT WOKE UP FOLLOWING COMMANDS AND WAS REPORTED TO BE AT HOME DOING FINE ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433822 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77350-18 9927729

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention| S