BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 2080550 · Received May 6, 2011

    Report

    Report Number
    1058196-2011-00208
    Event Type
    Death
    Date Received
    May 6, 2011
    Date of Event
    December 13, 2009
    Report Date
    April 11, 2011
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE REPORT INDICATED THE OFF-LABEL USE OF THE ENTERPRISE VRD SYSTEM WITH SUCCESSFUL RECANALIZATION OF THE LEFT VERTEBRAL ARTERY OCCLUSION WITH TPA THROMBOLYSIS AND ASPIRATION THROMBECTOMY USING THE PENUMBRA ASPIRATION DEVICE. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT EXPIRED, AND THE DIAGNOSES AT THE TIME OF DEATH WERE ACUTE CEREBRAL AND CEREBELLAR INFARCTIONS, CEREBRAL EDEMA, COMA, ACUTE RESPIRATORY FAILURE, AND VERTEBRAL DISSECTION. THE SITE INDICATED THAT THE CAUSE OF DEATH WAS UNRELATED TO THE DEVICE AND PROCEDURE. THERE WAS AN UNDERLYING HIGH GRADE CALCIFIED STENOSIS OF THE LEFT DISTAL VERTEBRAL ARTERY WHICH WAS SUCCESSFULLY TREATED WITH ANGIOPLASTY AND STENTING. THERE IS AN OCCLUSION OF THE DISTAL LEFT PCA THAT WAS IMPROVING WITH TPA AND REOPRO. AFTER THE (LVA) WAS TREATED WITH AN ENTERPRISE SYSTEM THE (LVA) LEFT VERTEBRAL ARTERY, THERE IS A HIGH GRADE STENOSIS OF THE LEFT DISTAL VERTEBRAL ARTERY. THE RIGHT PI IS HYPOPLASTIC. THERE HAS BEEN RECANALIZATION OF THE LEFT PI AND P2 PCA, HOWEVER, THERE IS AN OCCLUSION OF THE LEFT P3 SEGMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death