BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 2220668 · Received August 23, 2011

    Report

    Report Number
    1058196-2011-00421
    Event Type
    Death
    Date Received
    August 23, 2011
    Report Date
    July 28, 2011
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT DEVELOPED (SAH) SUBARACHNOID HEMORRHAGE AS A COMPLICATION DURING ENTERPRISE STENT ASSISTED EMBOLIZATION OF AN ANEURYSM. THE PATIENT SUBSEQUENTLY DIED. THE SAH WAS UNRELATED TO THE STENT PROCEDURE. DESPITE MULTIPLE ATTEMPTS, NO FURTHER INFORMATION HAS BEEN AVAILABLE TO DATE. THERE IS NO STERILE LOT NUMBER INFORMATION AVAILABLE THUS NO DHR COULD BE PERFORMED. HEMORRHAGIC STROKE IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH STENT ASSISTED ANEURYSM COIL EMBOLIZATION PROCEDURES AND IS LISTED IN THE ENTERPRISE IFU AS SUCH. THE INHERENT RISK OF INTRODUCING DEVICES INTO THE DELICATE CEREBRAL VESSELS AS WELL AS THE CHANGES IN INTRACRANIAL PRESSURES AND ANATOMY POST COIL PLACEMENT WITHIN THE ANEURYSM CAN CONTRIBUTE TO THE OCCURRENCE OF INTRACRANIAL AND ANEURISMAL BLEEDING COMPLICATIONS. COIL EMBOLIZATION PATIENTS ARE STARTED AND MAINTAINED ON ANTICOAGULANT AND ANTI-PLATELET MEDICATION REGIMENS THAT CAN CONTRIBUTE TO THE LIKELY HOOD OF BLEEDING IN THE PERI AND POST OPERATIVE PHASES. ALL PRODUCTS UNDERGO A 100% INSPECTION PRIOR TO RELEASE FOR MARKETING. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. REVIEW OF THE VERY LIMITED INFORMATION DOES NOT SUGGEST WHAT FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    EVENT DATE IS UNKNOWN AT THIS TIME. PLEASE NOTE: THE CATALOG (UNK ENTERPRISE ENF) REPRESENTS AN UNKNOWN ENTERPRISE VRD. THE CATALOG AND LOT NUMBER FOR THE ACTUAL PRODUCT USED IN THE PATIENT IS UNKNOWN. AN INVESTIGATION IS IN PROCESS TO RETRIEVE THIS INFORMATION. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE PATIENT DEVELOPED (SAH) SUBARACHNOID HEMORRHAGE AS A COMPLICATION DURING ENTERPRISE STENT ASSISTED EMBOLIZATION OF AN ANEURYSM. THE PATIENT SUBSEQUENTLY DIED. THE SAH WAS UNRELATED TO THE STENT PROCEDURE.

    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 Death