BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 2001597 · Received February 25, 2011

    Report

    Report Number
    1058196-2011-00073
    Event Type
    Injury
    Date Received
    February 25, 2011
    Date of Event
    September 16, 2010
    Report Date
    February 2, 2011
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONALLY, THE FOLLOW-UP ANGIOGRAM DID NOT REVEAL ANY FACTORS WITH THE DEVICE OR VESSEL THAT MAY HAVE CONTRIBUTED TO THE EVENT. AFTER THE STENT AND COILING PROCEDURE WAS COMPLETED, THE VESSEL AND STENTED AREA WAS PATENT, AND THE ENTERPRISE WAS FULLY EXPANDED AND OPPOSED TO THE VESSEL WALL AFTER INITIAL PLACEMENT. THERE WAS NO INDICATION OF ANY CONDITIONS CAUSING HYPERCOAGULABLE STATE. THE VESSEL SIZE PROXIMAL DIAMETER WAS 3.0MM AND DISTALLY WAS 2.6MM. THE ANEURYSM NECK 8.8MM, AND THE NECK TO SAC RATIO WAS 8.8MM/28.0MM. MEDICATION GIVEN PRE-PROCEDURE CONSISTED OF PLAVIX, ASPIRIN, AND INTRA-PROCEDURE AND POST PROCEDURE HEPARIN. THE ACT MEASUREMENT WAS 112 SECONDS AND 243 SECONDS. THE ENTERPRISE VRD REMAINS IMPLANTED AND THEREFORE IS NOT AVAILABLE FOR ANALYSIS. LAKE REGION MEDICAL REVIEWED THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01422127. THE DEVICE HISTORY RECORD REVIEW ALSO INCLUDED A REVIEW OF THE CERTIFICATE OF CONFORMANCE RECEIVED FROM (B)(4), ALONG WITH LAKE REGION MEDICAL'S INTERNAL RECEIVING INSPECTION RECORDS FOR THE STENTS ISSUED TO THE COMPLAINT LOT. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. NEUROLOGICAL DEFICITS ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THIS TYPE OF PROCEDURE AS LISTED IN THE INSTRUCTIONS FOR USE. ALTHOUGH NO DEFINITIVE CONCLUSION CAN BE MADE, BASED ON THE REPORTED INFORMATION AND AS REPORTED BY THE PHYSICIAN THE PATIENT'S POST PROCEDURE NEUROLOGICAL CHANGES APPEAR TO BE RELATED TO THE MASS EFFECT OF THE COILED ANEURYSM. CLINICAL FACTORS INCLUDING ANEURYSM SIZE AND LOCATION APPEAR TO HAVE CONTRIBUTED TO THE EVENT WITH NO INDICATION OF ANY RELATED DEVICE DESIGN, MANUFACTURING OR PERFORMANCE ISSUES. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS ONE OF MULTIPLE PRODUCTS INVOLVED WITH THIS ADVERSE EVENT, WHICH IS ASSOCIATED WITH MFR REPORT # 1058196-2011-00073, 1058196-2011-00074, 1058196-2011-00075, 1058196-2011-00076, 1058196-2011-00077, 1058196-2011-00078, 1058196-2011-00079, 1058196-2011-00080, AND 1058196-2011-00081.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE CLINICAL STUDY (B)(4), INDICATED THAT THE PROCEDURE WAS COIL EMBOLIZATION ASSISTED WITH AN ENTERPRISE VRD (ENC452812) FOR AN ANEURYSM IN THE (BA) BASILAR ARTERY-TOP. THE DAY AFTER THE PROCEDURE THE PATIENT HAD OCULOMOTOR PARALYSIS OF THE LEFT SIDE ADDITIONALLY PREEXISTENT HEMIPLEGIA OF THE RIGHT SIDE HAD WORSENED. MEDICAL TREATMENT WAS PERFORMED USING HEPARIN, STEROIDS, AND GLYSEOL. APPROXIMATELY 5 DAYS AFTER THE EVENT, THE PATIENT RECOVERY WAS CONFIRMED AND WAS IN STABLE CONDITION. THE PHYSICIAN COMMENTED THAT INCREASE OF MASS EFFECT BY THE COIL EMBOLIZATION WAS SUSPECTED. THE COILS UTILIZED FOR THE PROCEDURE CONSISTED OF CODMAN COILS (CATALOG AND LOT NUMBERS UNKNOWN) ORBIT CF 8X24MM (X2), 9X25MM (X2), 6X15MM (1), 4X10MM (X5), 3.5X9MM (X2), 3X6MM (X4), 2.5X4.5 (X3), 2X2 (X3), AND HYDRO COIL (X3). ANGIOGRAMS WERE PERFORMED DURING THE EVENT, AND THE ENTERPRISE WAS FULLY EXPANDED, PATENT, APPOSED TO THE VESSEL WALL AND IN A STABLE POSITION AS COMPARED TO POSITION AFTER PLACEMENT.

    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 01422127

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention| S COILS