BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 2770726 · Received October 3, 2012

    Report

    Report Number
    2029214-2012-00522
    Event Type
    Injury
    Date Received
    October 3, 2012
    Date of Event
    August 30, 2012
    Report Date
    September 9, 2012
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE PROCEDURE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS IMPLANTED IN THE PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH ONE PIPELINE ON (B)(6) 2012 WITH NO COMPLICATIONS. ON (B)(6) 2012, THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL AND FOUND TO HAVE A STROKE DUE TO AN OCCLUDED VESSEL. THEY SPECULATE THE PATIENT DID NOT TAKE PLAVIX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77400-20 MA12-025

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability