BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 2910936 · Received January 11, 2013

    Report

    Report Number
    1058196-2013-00012
    Event Type
    Death
    Date Received
    January 11, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 19, 2012
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT REMAINS IMPLANTED, AND WILL NOT BE RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. THIS IS ONE OF MULTIPLE PRODUCTS INVOLVED WITH THIS ADVERSE EVENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2013-00011 AND 1058196-2013-00013. THE CATALOG AND LOT NUMBER FOR THE DEVICES WERE NOT PROVIDED, THEREFORE THE DEVICE NOTED (UNK ENTERPRISE ENC) REPRESENTS AN ENTERPRISE VRD THAT THE CATALOG NUMBER BEGINS WITH ENC. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: TWO UNKNOWN PROWLER PLUS MICROCATHETER; ENTERPRISE STENT: ENC452212/(B)(4).

    Description of Event or Problem · 1

    THE PATIENT HAD A WIDE-NECK ANEURYSM. WHEN THE PHYSICIAN WITHDREW THE PROWLER PLUS MICROCATHETER TO DEPLOY THE STENT, THE MICROCATHETER COULD NOT BE MOVED. THEN HE PUSHED THE MICROCATHETER FORWARD AND IT STILL COULD NOT BE MOVED. THE PHYSICIAN WITHDREW THE MICROCATHETER AND THE STENT TOGETHER AND CHANGED TO ANOTHER SIMILAR STENT AND ANOTHER PROWLER PLUS MICROCATHETER TO COMPLETE THE PROCEDURE. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH BOTH MICROCATHETERS. THERE WERE NO DAMAGES NOTED ON BOTH MICROCATHETERS AND THE FIRST STENT PRIOR TO AND AFTER USE. THE FIRST STENT WAS ABLE TO BE REMOVED FROM THE MICROCATHETER, OUTSIDE OF THE PATIENT. THE PHYSICIAN USED GREAT FORCE TO EXPOSE THE STENT OUT OF THE MICRO-CATHETER OUTSIDE PATIENT BODY. DUE TO THE PROBLEM THAT OCCURRED, THE PATIENT SUFFERED THROMBOSIS AND WAS IN A COMA. THROMBOLYSIS MEDICATION TREATMENT WAS USED TO TREAT THE THROMBOSIS. THE PATIENT IS DECEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17806 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM CNV ENTERPRISE SES (NJE) NJE CORDIS NEUROVASCULAR, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death| L