BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 3350947 · Received September 16, 2013

    Report

    Report Number
    1058196-2013-00250
    Event Type
    Death
    Date Received
    September 16, 2013
    Date of Event
    June 10, 2013
    Report Date
    September 16, 2013
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS, AND ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    DUMONT ET AL, J NEUROINTERVENTION SURGERY, PUBLISHED ONLINE JULY 2, 2013, DOI: 10.1136/NEURINTSURG-2013-010794 FOR CASE 9 INDICATED THAT PATIENT WITH A HISTORY OF DIABETES MELLITUS AND SMOKING DIED OF VENTRICULAR FIBRILLATION SECONDARY TO MYOCARDIAL INFARCTION FOLLOWING THROMBECTOMY PROCEDURE FOR ISCHEMIC STROKE USING AN ENTERPRISE STENT (ENF452812/LOT UNK) USED OFF LABELED. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, AND THE LOT NUMBER WAS NOT PROVIDED TO CONDUCT DHR REVIEW. MYOCARDIAL INFARCTION REPORTED AFTER THE THROMBECTOMY PROCEDURE COULD NOT BE CONFIRMED. HOWEVER, THE PATIENT HAD PREDISPOSITION TO FACTORS THAT MAY HAVE CONTRIBUTED TO THE EVENT. ADDITIONALLY, WITH THE LIMITER INFORMATION IT IS NOT POSSIBLE TO DETERMINE THE CAUSE. NO DHR WAS CONDUCTED BECAUSE THE LOT WAS NOT PROVIDED. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    DUMONT ET AL, J NEUROINTERVENTION SURGERY, PUBLISHED ONLINE JULY 2, 2013, DOI: 10.1136/NEURINTSURG-2013-010794 FOR CASE 9 INDICATED THAT PATIENT WITH A HISTORY OF DIABETES MELLITUS AND SMOKING DIED OF VENTRICULAR FIBRILLATION SECONDARY TO MYOCARDIAL INFARCTION FOLLOWING THROMBECTOMY PROCEDURE FOR ISCHEMIC STROKE USING AN ENTERPRISE STENT (ENF452812/LOT UNK) OFF LABELED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463715 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM CNV ENTERPRISE SES (NJE) NJE CORDIS NEUROVASCULAR, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death