BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 3526425 · Received December 18, 2013

    Report

    Report Number
    2029214-2013-00980
    Event Type
    Injury
    Date Received
    December 18, 2013
    Date of Event
    November 18, 2013
    Report Date
    November 19, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    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 DEVICES INVOLVED IN THE EVENT ARE AS FOLLOWS:MODEL: FA-71450-30, LOT: 9625577, DOM: 04-AUG-2012, EXP: 04-AUG-2015; MODEL: FA-71475-30, LOT: 9690266, DOM: 09-JAN-2013, EXP: 09-JAN-2016;MODEL: FA-71500-35, LOT: 9722777, DOM: 20-MAR-2013, EXP: 19-MAR-2016;MODEL: FA-71500-30, LOT: 9727936, DOM: 01-APR-2013, EXP: 31-MAR-2016.(B)(4).

    Description of Event or Problem · 1

    TREATMENT OF A GIANT UNRUPTURED ANEURYSM MEASURING 30MM X 10MM LOCATED IN THE CAVERNOUS SEGMENT OF THE LEFT ICA (INTERNAL CAROTID ARTERY). THE ANEURYSM WAS PREVIOUSLY TREATED WITH COILS AND RECANALIZED. DUAL ANTI-PLATELET THERAPY WAS GIVEN TO THE PATIENT. ON (B)(6) 2013, THE PATIENT UNDERWENT PIPELINE EMBOLIZATION TREATMENT IN WHICH FIVE PIPELINES (4.00MM X 35MM; 4.50MM X 30MM; 4.75MM X 30MM; 5.00MM X 35MM; AND 5.00MM X 30MM) WERE IMPLANTED. THE PATIENT HAD MULTIPLE ISCHEMIC STROKES POST PROCEDURE THAT CAUSED HER TO BECOME APHASIC. POST PROCEDURE ANGIOGRAPHY SHOWED AN ECLIPSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661507 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-71400-35 9702790

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Disability