BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 3864440 · Received June 10, 2014

    Report

    Report Number
    2029214-2014-00338
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    April 23, 2014
    Report Date
    May 13, 2014
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 SMALL UNRUPTURED ANEURYSM MEASURING 4.7MM X 3.5MM X 2.4MM LOCATED IN OPHTHALMIC SEGMENT OF THE LEFT ICA (INTERNAL CAROTID ARTERY). THE PATIENT'S ANATOMY WAS TORTUOUS. THE PATIENT WAS GIVEN PLAVIX. ON (B)(6) 2014, THE PATIENT UNDERWENT PIPELINE EMBOLIZATION TREATMENT. DURING THE PROCEDURE, IT WAS REPORTED THE FIRST PIPELINE (4.50MM X 14MM) BROKE AND IT WAS REMOVED FROM THE PATIENT BY TRAPPING THE BRAID BETWEEN THE CAPTURE COIL AND CATHETER. ANOTHER PIPELINE (4.50MM X 12MM) WAS DEPLOYED, BUT IT DID NOT OPEN DESPITE THREE ATTEMPTS SO IT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT PIPELINE. SAME EVENT AS MDR # 2029214-2014-00337.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339220 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77450-14 9534426

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR