BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 2112098 · Received June 2, 2011

    Report

    Report Number
    2029214-2011-00128
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 3, 2011
    Report Date
    May 3, 2011
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    HCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PIPELINE WAS RETURNED INSIDE THE CATHETER. A LARGE AMOUNT OF BLOOD WAS FOUND INSIDE THE CATHETER AND PIPELINE WHICH POSSIBLY CAUSE THE PIPELINE NOT TO OPEN.(B)(4)

    Description of Event or Problem · 1

    TREATMENT OF AN ANEURYSM. IT WAS REPORTED THE PIPELINE DID NOT OPEN DURING DELIVERY. THE SYSTEM WAS REMOVED FROM THE PATIENT WAS ANOTHER ONE WAS USED TO COMPLETE THE PROCEDURE.NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIPELINE EMBOLIZATION DEVICE EMBOLIZATION DEVICE HCG EV3 NEUROVASCULAR FA-77475-16 SE09-050

    Patients

    Seq Age Sex Outcome Treatment
    1