BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 1962196 · Received January 17, 2011

    Report

    Report Number
    1058196-2011-00030
    Event Type
    Death
    Date Received
    January 17, 2011
    Date of Event
    October 4, 2010
    Report Date
    December 20, 2010
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    HDE H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    BASED ON ADDITIONAL INFORMATION RECEIVED, THE ADVERSE EVENT OF SUBARACHNOID HEMORRHAGE/DEATH IS BEING CHANGED FROM A SERIOUS INJURY/DEATH REPORTABLE COMPLAINT TO A NON-COMPLAINT FILE. THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT THE PATIENT WAS ENROLLED IN A CLINICAL STUDY '(B)(4) PMS ENTERPRISE.' THE EMERGENT STUDY INDEX PROCEDURE WAS FOR A STENT ASSISTED COIL EMBOLIZATION FOR A RUPTURED ANEURYSM (BA-SCA). AN ENTERPRISE VRD STENT WAS DEPLOYED. THE PATIENT WAS ADMITTED FOR AN ACUTE STAGE SUBARACHNOID HEMORRHAGE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY ISSUES. HOWEVER, FIVE DAYS LATER THE PATIENT EXPIRED WITHOUT RECOVERY. THE PHYSICIAN REPORTED THAT THE DEATH WAS DUE TO THE ACUTE SUBARACHNOID HEMORRHAGE AND THERE WAS NO CASUAL RELATIONSHIP TO THE ENTERPRISE VRD DEVICE OR ANY DEVICES USED IN THE PROCEDURE. ADDITIONAL INFORMATION RECEIVED INDICATED THE SAME LESION WAS TREATED TWICE PREVIOUSLY. THERE IS NO INFORMATION AVAILABLE REGARDING THE PREVIOUS TREATMENT OF THE ANEURYSM. A RUPTURED CEREBRAL ANEURYSM IS AN INTRACRANIAL CATASTROPHE, ASSOCIATED WITH VERY HIGH MORBIDITY AND MORTALITY. ANEURISMAL SUBARACHNOID HEMORRHAGE IS ASSOCIATED WITH MORTALITY RATES REPORTED BETWEEN 25 AND 50 PERCENT FROM THE CONSEQUENCES OF THE INITIAL BLEEDING. BASED ON THE PHYSICIAN'S REPORT THAT THE PATIENT'S DEATH WAS DUE TO HER BASELINE SAH WITH NO CASUAL RELATIONSHIP TO ANY OF THE DEVICES USED IN THE PROCEDURE, THIS WILL BE CONSIDERED A NON-COMPLAINT AND PROCESSED ACCORDINGLY. PLEASE NOTE THAT THIS IS THE FINAL REPORT FOR THIS PRODUCT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT THE PATIENT WAS ENROLLED IN A CLINICAL STUDY (B)(4). THE EMERGENT STUDY INDEX PROCEDURE WAS FOR A STENT ASSISTED COIL EMBOLIZATION FOR A RUPTURED ANEURYSM (BA-SCA). AN ENTERPRISE VRD STENT WAS DEPLOYED. THE PATIENT WAS ADMITTED FOR AN ACUTE STAGE SUBARACHNOID HEMORRHAGE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY ISSUES. HOWEVER, FIVE DAYS LATER, THE PATIENT EXPIRED WITHOUT RECOVERY. THE PHYSICIAN COMMENTED THAT THE DEATH WAS DUE TO THE SUBARACHNOID HEMORRHAGE AND THERE WAS NO CASUAL RELATIONSHIP TO THE ENTERPRISE VRD DEVICE. ADDITIONAL INFORMATION RECEIVED INDICATED THE SAME LESION WAS TREATED TWICE PREVIOUSLY. THERE WAS NO CASUAL RELATIONSHIP TO ANY OF THE DEVICES USED FOR THE PROCEDURES. THE CAUSE OF DEATH WAS REPORTED TO BE ACUTE STAGE SUBARACHNOID HEMORRHAGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    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 01421603

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death