BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 1880887 · Received October 25, 2010

    Report

    Report Number
    1058196-2010-00307
    Event Type
    Death
    Date Received
    October 25, 2010
    Date of Event
    June 11, 2010
    Report Date
    October 15, 2010
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    HDE H60001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE (B)(4) STUDY INDICATED THAT THE PATIENT WAS ADMITTED WITH AN ACUTELY RUPTURE ANEURYSM OF THE RIGHT SUPRACLINOID CAROTID ARTERY (SAC HEIGHT 4MM, SAC WIDTH 8 AND NECK 8MM). THE WFNS SCALE WAS III, AND THE MODIFIED RANKIN SCALE (MRS) WAS 2. NO BALLOON WAS USED FOR THE PROCEDURE. A 14MM ENTERPRISE VRD WAS PLACED AT THE ANEURYSM NECK. IT WAS INDICATED THAT THERE WAS DIFFICULT COIL PLACEMENT VIA A JAILED MICROCATHETER TECHNIQUE. THIS WAS INDICATED AS UNRELATED TO THE STENT AND NOT CLINICALLY SIGNIFICANT. IT WAS INDICATED THAT THE PROCEDURE WAS STOPPED DUE TO TREATMENT WAS ACHIEVED AND NO TECHNICAL ADVERSE EVENT WAS NOTED. THERE WAS NO DISSECTION, THROMBUS, COIL PROTRUSION, OR VESSEL OCCLUSION. THE ANGIOGRAPHIC RESULT INDICATED THAT THERE WAS RESIDUAL ANEURYSM. HEPARIN WAS GIVEN INTRA-PROCEDURE, AND POST PROCEDURE ASPIRIN. APPROXIMATELY SEVEN DAYS AFTER THE INDEX PROCEDURE, THERE WAS SUDDEN DEGRADATION OF THE PATIENT'S CONDITION RELATED TO MAJOR AND DIFFUSE VASOSPASM CAUSING MULTIPLE CEREBRAL INFARCTIONS. INTRA-VENOUS AND INTRA-ARTERIAL MEDICAL TREATMENT WAS GIVEN. THE MODIFIED RANKIN SCALE (MRS) WAS 6 WHICH INDICATES DEATH. NO FURTHER INFORMATION IS AVAILABLE. THE ENTERPRISE VRD REMAINS IMPLANTED. THE LOT NUMBER IS NOT KNOWN; THEREFORE, A DEVICE HISTORY RECORD REVIEW CANNOT BE COMPLETED. A COMMON COMPLICATION OF SUBARACHNOID HEMORRHAGE (SAH) IS VASOSPASM, WHICH IS A NARROWING (SPASM) OF AN ARTERY. VASOSPASM IS REPORTED TO OCCUR IN AS MANY AS 70% OF PATIENTS WITH SAH AND IS CLINICALLY SYMPTOMATIC IN AS MANY AS 30% OF PATIENTS. MOST COMMONLY, THIS OCCURS 4-14 DAYS AFTER THE HEMORRHAGE. VASOSPASM CAN LEAD TO IMPAIRED CEREBRAL AUTOREGULATION AND MAY PROGRESS TO CEREBRAL ISCHEMIA AND INFARCTION. ISCHEMIC SYMPTOMS FROM VASOSPASM OCCUR IN ABOUT ONE-THIRD OF ALL PATIENTS WITH SUBARACHNOID HEMORRHAGE. ALTHOUGH A DEFINITIVE CONCLUSION CANNOT BE MADE, IT APPEARS THE POST PROCEDURE MAJOR AND DIFFUSE VASOSPASM RESULTING IN MULTIPLE CEREBRAL INFARCTIONS WAS LIKELY DUE TO THE PRE-PROCEDURE SAH. THERE IS NO INDICATION OF ANY DEVICE PERFORMANCE ISSUES OR RELATIONSHIP ANY ENTERPRISE DESIGN OR MANUFACTURING ISSUES. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE (B)(4) STUDY INDICATED THAT PATIENT 4-2 WAS ADMITTED WITH AN ACUTELY RUPTURE ANEURYSM OF THE RIGHT SUPRACLINOID CAROTID ARTERY (SAC HEIGHT 4MM, SAC WIDTH 8 AND NECK 8MM), AND AN ENTERPRISE 14MM STENT WAS PLACED AT THE ANEURYSM NECK. DURING THE INDEX PROCEDURE, THERE WAS DIFFICULT COIL PLACEMENT. APPROXIMATELY SEVEN DAYS AFTER THE INDEX PROCEDURE, SUDDEN DEGRADATION RELATED TO MAJOR AND DIFFUSE VASOSPASM CAUSING MULTIPLE CEREBRAL INFARCTION AND THE MODIFIED RANKIN SCALE (MRS) WAS 6 (DEAD). THE PATIENT'S DID NOT HAVE PREVIOUS SUBARACHNOID HEMORRHAGE FROM ANOTHER ANEURYSM. THE (B)(6) SCALE WAS III, AND THE MODIFIED RANKIN SCALE (MRS) WAS 2. A JAILED TECHNIQUE WAS UTILIZED. NO BALLOON WAS USED FOR THE PROCEDURE. THE TREATMENT WAS ACHIEVED AND NO TECHNICAL ADVERSE EVENT WAS NOTED. THE ANGIOGRAPHIC RESULT INDICATED THAT THERE WAS RESIDUAL ANEURYSM. HEPARIN WAS GIVEN INTRA-PROCEDURE, AND POST PROCEDURE ASPIRIN.

    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. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Death COILS