BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PIPELINE EMBOLIZATION DEVICE

    MDR report key: 3033745 · Received April 3, 2013

    Report

    Report Number
    2029214-2013-00322
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 11, 2013
    Manufacturer
    EV3 NEUROVASCULAR
    Product Code
    OUT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE EVENT WILL NOT BE RETURNED FOR EVALUATION AS IT WAS IMPLANTED IN THE PATIENT. (B)(4).

    Description of Event or Problem · 1

    TREATMENT OF A LEFT UNRUPTURED CAV (CAVERNOUS) ANEURYSM MEASURING 14MM X 7MM. DURING PIPELINE DEPLOYMENT, IT WAS REPORTED THAT THE PROXIMAL END DID NOT FULLY OPEN DESPITE MANIPULATING THE MARKSMAN CATHETER. THE PHYSICIAN ATTEMPTED TO OPEN THE PIPELINE BY PULLING THE CAPTURE COIL THROUGH IT, BUT WITHOUT SUCCESS. CLOT BEGAN TO FORM IN THE PIPELINE; THEREFORE, INTEGRILIN WAS ADMINISTERED TO THE PATIENT AND HIGH BLOOD FLOW WAS RESTORED. A J WIRE WAS ADVANCED AROUND THE ACOM (ANTERIOR COMMUNICATING ARTERY) TO THE PIPELINE AND MANAGED TO OPEN IT A LITTLE MORE. THE CASE CONCLUDED WITH THE PIPELINE APPROXIMATELY 55% OPEN, BUT THERE WAS FULL BLOOD FLOW TO ALL THE BRANCHES AND STAGNATION IN THE ANEURYSM. NO INJURY WAS REPORTED WITH THE PATIENT AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135770 PIPELINE EMBOLIZATION DEVICE FLOW DIVERSION OUT EV3 NEUROVASCULAR FA-77350-16 9663130

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention| S