BEUDAMED
    FDA Adverse Event Death Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 2902170 · Received January 8, 2013

    Report

    Report Number
    2029214-2013-00005
    Event Type
    Death
    Date Received
    January 8, 2013
    Date of Event
    July 13, 2011
    Report Date
    December 10, 2012
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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-77400-16 (QTY 2); LOT#: NOT REPORETED; DOM: N/A; EXP: N/A. (B)(4).

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM THE INTREPED CLINICAL DATABASE. TREATMENT OF A RIGHT UNRUPTURED INTERNAL CAROTID ARTERY (ICA) ANEURYSM MEASURING 8.71MM X 3.5MM. A TOTAL OF THREE PIPELINES WERE USED IN THE PATIENT. POST PIPELINE PROCEDURE, IT WAS REPORTED THAT THE PATIENT WAS PRESENTED WITH AN ACUTE RIGHT ICA STROKE AND WAS PUT ON HEPARIN TO PREVENT FURTHER STROKES. A COMPUTER TOMOGRAPHY ANGIOGRAPHY (CTA) AND MAGNETIC RESONANCE ANGIOGRAM (MRA) WAS PERFORMED ON (B)(6) 2011 THAT SHOWED A HIGH GRADE STENOSIS WITH PSEUDO ANEURYSM AND DISSECTION. THE PATIENT PRESENTED AGAIN ON (B)(6) 2011 WITH AN INTRACRANIAL HEMORRHAGE AND SUBSEQUENTLY EXPIRED THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8697 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77400-18 NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death