BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 2902206 · Received January 8, 2013

    Report

    Report Number
    2029214-2013-00017
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 11, 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 HAS BEEN RETURNED AND EVALUATED. THE PIPELINE WAS FOUND DETACHED FROM THE CAPTURE COIL. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT HAS NOT BEEN RETURNED FOR EVALUATION. (B)(4).

    Description of Event or Problem · 1

    TREATMENT OF A LEFT OPHTHALMIC ANEURYSM MEASURING 8MM X 10MM. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PIPELINE WOULD NOT RELEASE FROM THE CAPTURE COIL AND IT WAS REMOVED FROM THE PATIENT. NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9313 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77475-18 9527606

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR