BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 3182095 · Received June 21, 2013

    Report

    Report Number
    2029214-2013-00566
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 27, 2013
    Report Date
    May 31, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE PIPELINE, PUSHWIRE, AND MARKSMAN CATHETER WERE RETURNED FOR EVALUATION. THE PIPELINE WAS FOUND TO BE OPENED AND RELEASED FROM THE CAPTURE COIL; THEREFORE, THE EVENT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    TREATMENT OF A LEFT CAROTID OPHTHALMIC SEGMENT, COMMUNICATING, DISSECTING ANEURYSM. DURING THE PROCEDURE, IT WAS REPORTED THAT THE FIRST PIPELINE COULD NOT BE RELEASED AND THE ENTIRE SYSTEM WAS REMOVED FROM THE PATIENT. THE SECOND PIPELINE DID NOT FULLY OPEN DISTALLY DESPITE GUIDEWIRE MANIPULATION AND BALLOON ANGIOPLASTY. AN OCCLUSIVE THROMBUS WAS FORMED IN THE ARTERY SO THE PHYSICIAN PERFORMED A CONTROL FROM THE RIGHT CAROTID TO DISCOVER THAT THERE WAS FLOW COMING FROM THE A-COMM (ANTERIOR COMMUNICATING) ARTERY; THEREFORE, THE PROCEDURE WAS CONCLUDED. IT WAS REPORTED THAT THE PATIENT HAD VIGIL, APHASIA, AND MODERATE TO SEVERE HEMIPARESIS.SAME EVENT AS MDR# 2029214-2013-00567.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282182 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77375-20 9669568

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR