BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 3770768 · Received April 24, 2014

    Report

    Report Number
    2029214-2014-00229
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    March 27, 2014
    Report Date
    March 27, 2014
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PIPELINE, MARKSMAN, AND PUSHWIRE WERE RETURNED FOR EVALUATION. THE EVALUATION COULD NOT DETERMINE THE CAUSE OF THE EVENT AS THE PIPELINE WAS FOUND RELEASED FROM THE CAPTURE COIL AND FULLY OPENED; HOWEVER, THE BRAID AND CAPTURE COIL WERE FOUND DAMAGED WHICH MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE. ALL DEVICES ARE 100% INSPECTED FOR DAMAGES AND IRREGULARITIES DURING MANUFACTURE. (B)(4).

    Description of Event or Problem · 1

    TREATMENT OF SMALL UNRUPTURED SACCULAR ANEURYSM MEASURING 4MM LOCATED IN THE P-COMM (POSTERIOR COMMUNICATING) ARTERY. THE LOCATION OF THE ANEURYSM WAS STATED TO BE OFF-LABEL. THE PATIENT'S ANATOMY WAS TORTUOUS. THE PATIENT WAS GIVEN HEPARIN AND PLAVIX. ON (B)(6) 2014, THE PATIENT UNDERWENT PIPELINE EMBOLIZATION TREATMENT. DURING THE PROCEDURE, IT WAS REPORTED THE PIPELINE (4MM X 12MM) COULD NOT BE RELEASED FROM THE CAPTURE COIL AND IT WAS REMOVED FROM THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248787 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77400-12 9806941

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR