BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 3231818 · Received December 6, 2012

    Report

    Report Number
    2029214-2012-00684
    Event Type
    Malfunction
    Date Received
    December 6, 2012
    Date of Event
    October 30, 2012
    Report Date
    November 6, 2012
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT WAS DISCARDED. (B)(4).

    Description of Event or Problem · 1

    TREATMENT OF AN ANEURYSM. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PIPELINE IT DID NOT OPEN DISTALLY AND WAS REMOVED FROM THE PATIENT. ANOTHER PIPELINE WAS USED IN ITS PLACE TO COMPLETE THE PROCEDURE. NO INJURY WAS REPORTED WITH THE PT AS A RESULT OF THE PROCEDURE. SAME EVENT AS MDR # 2029214-2012-00683.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77400-16 9422456

    Patients

    Seq Age Sex Outcome Treatment
    1