BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 2803002 · Received October 24, 2012

    Report

    Report Number
    2029214-2012-00561
    Event Type
    Injury
    Date Received
    October 24, 2012
    Date of Event
    April 30, 2012
    Report Date
    September 25, 2012
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    INFORMATION FROM (B)(4) FROM CLINICAL DATABASE. TREATMENT OF AN ANEURYSM. IT WAS REPORTED THAT THE PATIENT UNDERWENT PIPELINE EMBOLIZATION PROCEDURE AND WAS FOUND TO HAVE A MILD STENT STENOSIS DURING FOLLOW UP ANGIOGRAPHY. NO OTHER COMPLICATIONS WERE REPORTED WITH THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77275-16 NOT REPORTED

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female