BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 1810791 · Received August 23, 2010

    Report

    Report Number
    1058196-2010-00228
    Event Type
    Injury
    Date Received
    August 23, 2010
    Date of Event
    July 7, 2010
    Report Date
    July 27, 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 11MM NECK OF A PREVIOUSLY CLIPPED VERTEBRAL ARTERY (VA) ANEURYSM COULD NOT BE COVERED WITH THE FIRST ENTERPRISE VRD, SO A SECOND OVERLAPPING ENTERPRISE VRD WAS PLACED WITH FULL COVERAGE OF THE NECK ACHIEVED. THERE IS NO INFORMATION REGARDING THE CIRCUMSTANCES CONTRIBUTING TO THE DELIVERY/PLACEMENT OF THESE TWO ENTERPRISE VRDS OR CIRCUMSTANCES LEADING TO THE PLACEMENT OF THE SECOND ONE. DURING INSERTION OF THE 10TH COIL ENGAGEMENT OF THE NON-CORDIS (SL10/BOSTON SCIENTIFIC) MICROCATHETER WAS LOST. SINCE THE PROXIMAL PART OF THE ANEURYSM WAS NOT EMBOLIZED COMPLETELY BY THE COILS, ANOTHER ENTERPRISE VRD WAS PLACED IN THE PROXIMAL PART OF THE ANEURYSM NECK INSIDE OF THE PREVIOUSLY PLACED STENTS AND THE PROCEDURE WAS COMPLETED. TWO HOURS AFTER THE PROCEDURE THROMBUS WAS OBSERVED INSIDE THE VRD AND COMPLETE OCCLUSION WAS CONFIRMED FROM VA UNION TO VRD PROXIMAL EDGE BY ANGIOGRAPHY. PTA WAS CONDUCTED WITH ARTERIAL INJECTION OF FASUDIL HYDROCHLORIDE TO TREAT THE THROMBUS. ANOTHER ENTERPRISE VRD WAS PLACED; HOWEVER NO IMPROVEMENT OF BLOOD FLOW WAS NOTED. THIS WAS FOLLOWED BY PLACEMENT OF ANOTHER ENTERPRISE VRD, UROKINASE ADMINISTRATION, AND PLACEMENT OF A NON-CORDIS DRIVER STENT AT THE PROXIMAL EDGE OF ANEURYSM. SOME IMPROVEMENT OF BLOOD FLOW WAS NOTED AND THE PROCEDURE WAS COMPLETED. THE ANEURYSM DIMENSIONS WERE 9X10MM, AND THE NECK WAS APPROXIMATELY 11MM. IT WAS REPORTED THAT THERE IS NO INFORMATION AVAILABLE REGARDING PRE OR INTRA PROCEDURAL ANTIPLATELET THERAPY, ANTICOAGULATION, OR MEASUREMENT OF EFFECTIVENESS. PROCEDURAL FILMS ARE NOT AVAILABLE. NO SPECIFICS REGARDING THE PATIENT'S NEUROLOGICAL STATUS IS AVAILABLE, IT WAS REPORTED THAT HE IS "STILL BEING FOLLOWED." LAKE REGION MEDICAL REVIEWED THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01420433 WHICH CORRESPONDS TO CORDIS LOT 13471845. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. ADDITIONAL REVIEW OF THE SUBCOMPONENT STENT LOT BY (B)(4) FOUND NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. THROMBOTIC EVENTS ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THIS TYPE OF PROCEDURE AS OUTLINED IN THE INSTRUCTIONS FOR USE (IFU). DUE TO THE LACK OF INFORMATION PERTAINING TO THE PLACEMENT OF THE ENTERPRISE STENTS, NO CONCLUSION CAN BE MADE REGARDING FACTORS THAT MAY HAVE CONTRIBUTED TO THE SECOND ENTERPRISE BEING PLACED. IT APPEARS THAT THE THIRD ENTERPRISE STENT MAY HAVE BEEN PLACED FOR DIVERSION OF FLOW INTO THE ANEURYSM. IN ADDITION, TWO ENTERPRISE VRDS WERE PLACED TO TREAT THE POST PROCEDURE THROMBUS. AS OUTLINED IN THE IFU, THE INDICATED USE OF THE ENTERPRISE VRD IS TO PREVENT COILS FROM PROTRUDING OUT OF THE ANEURYSM INTO THE PARENT ARTERY. IN ADDITION, IT PRECAUTIONS THAT THE PERFORMANCE AND SAFETY OF TWO OR MORE OVERLAPPED STENTS HAS NOT BEEN ESTABLISHED. USAGE OTHER THAN THE APPROVED LABELING MAY INVOLVE RISKS NOT DESCRIBED IN THE LABELING. THE STENTS REMAIN IMPLANTED AND FILMS ARE NOT AVAILABLE. WITH REVIEW OF THE LIMITED AVAILABLE INFORMATION, ALTHOUGH NO CONCLUSION CAN BE MADE REGARDING THE REPORTED EVENTS, PATIENT, PROCEDURAL, AND PHARMACOLOGICAL FACTORS MAY HAVE CONTRIBUTED. THERE IS NO INDICATION OF ANY DEVICE MANUFACTURING ISSUES CONTRIBUTING TO THE EVENTS. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS ONE OF FIVE PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2010-00228, 1058196-2010-00229, 1058196-2010-00230, AND 1058196-2010-00231.

    Additional Manufacturer Narrative · 1

    CORDIS LOT NUMBER 01420433. PER LAKE REGION REPORT (B)(4): LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01420433. (B)(4). THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. MANUFACTURING RECORDS FOR LOT 01420433 WERE REVIEWED AND PRODUCT MET ALL QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. A DHR REVIEW WAS REQUESTED TO (B)(4), AND THE RESULTS INDICATE THAT THE STENT SHIPPED MEETS SPECIFIED RELEASE REQUIREMENTS. THIS ONE OF FIVE PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2010-00228, 1058196-2010-00229, 1058196-2010-00230, AND 1058196-2010-00231. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE PROCEDURE WAS COIL EMBOLIZATION FOR VA-AN AFTER CLIPPING. THE VESSEL WAS SLIGHTLY CALCIFIED. AFTER TWO VRD WERE PLACED IN THE CLIPPING OF VA-AN, COIL EMBOLIZATION WAS DONE. WHILE THE 10TH COIL WAS BEING INSERTED IN THE ANEURYSM, ENGAGEMENT OF MICROCATHETER (SL10, BOSTON SCIENTIFIC) CAME OFF. SINCE THE PROXIMAL PART OF THE ANEURYSM WAS NOT EMBOLIZED COMPLETELY BY THE COILS, ANOTHER VRD WAS PLACED IN THE PROXIMAL PART OF THE ANEURYSM NECK AND PROCEDURE WAS COMPLETED. TWO HOURS AFTER THE SURGERY, THROMBUS WAS OBSERVED INSIDE VRD AND COMPLETE OCCLUSION WAS CONFIRMED FROM VA UNION TO VRD PROXIMAL EDGE BY ANGIOGRAPHY. TO TREAT THE THROMBUS, PTA WAS CONDUCTED, ARTERIAL INJECTION OF FASUDIL HYDROCHLORIDE WAS CONDUCTED AND ANOTHER VRD WAS PLACED. HOWEVER NO IMPROVEMENT NOTED WITH BLOODSTREAM. ANOTHER VRD WAS PLACED, AND UROKINASE ADMINISTRATION WAS DONE INTRAVENOUSLY, AND THEN DRIVER STENT AS PLACED IN THE PROXIMAL EDGE OF ANEURYSM. SOME IMPROVEMENT NOTED WITH BLOODSTREAM. THE PROCEDURE WAS COMPLETED. THE LOT NUMBERS OF THE COMPLAINT PRODUCT ARE 13471845, 13471863 AND 13471845. THE ENTERPRISE STENTS WERE PLACED IN THE FOLLOWING ORDER 2ND VRD WAS OVERLAPPED WITH 1ST VRD (ENC453712). THIRD VRD WAS PLACED INSIDE 1ST VRD AND 2ND VRD. TWO ENTERPRISE VRD STENTS WERE PLACE BECAUSE THE ANEURYSM NECK COULD NOT BE COVERED WITH THE 1ST VRD. AFTER PLACEMENT OF THE TWO VRD STENTS, THE NECK WAS COVERED. THE ANEURYSM DIMENSIONS WERE 9X10MM, AND THE NECK WAS APPROXIMATELY 11MM. THE PATIENT IS FOLLOWING-UP.

    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 13471845

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Life Threatening| R SL 10, COILS, AND VRD