BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 3851619 · Received June 5, 2014

    Report

    Report Number
    2029214-2014-00315
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 9, 2014
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS IT WAS DISCARDED. (B)(4).

    Description of Event or Problem · 1

    TREATMENT OF A SMALL UNRUPTURED SACCULAR ANEURYSM MEASURING 10MM X 4MM LOCATED IN THE CAVERNOUS SEGMENT OF THE RIGHT ICA (INTERNAL CAROTID ARTERY). THE PATIENT WAS GIVEN DUAL ANTIPLATELET THERAPY. ON (B)(6) 2014, THE PATIENT UNDERWENT PIPELINE (4MM X 20MM) EMBOLIZATION TREATMENT. DURING THE PROCEDURE, IT WAS REPORTED THE PIPELINE COULD NOT BE OPENED DESPITE MANIPULATION OF THE WIRE AND MICROCATHETER. THE PIPELINE WAS REMOVED FROM THE PATIENT BY TRAPPING THE BRAID BETWEEN THE CAPTURE COIL AND MICROCATHETER. A SHORTER DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER ISSUES. POST PROCEDURAL IMAGING REVEALED AN ECLIPSE. THE PATIENT'S CONDITION WAS REPORTED TO BE STABLE. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328472 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77400-20 9902774

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR