BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 2497549 · Received March 20, 2012

    Report

    Report Number
    1058196-2012-00126
    Event Type
    Injury
    Date Received
    March 20, 2012
    Date of Event
    April 27, 2011
    Report Date
    March 1, 2012
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER LAKE REGION REPORT (B)(4) LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01425457. 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. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    ANTIPLATELET THERAPY INCLUDED ASPIRIN 100MG/DAY: (B)(6) 2011-, CLOPIDOGREL SULFATE 75MG/DAY: (B)(6) 2011-. ARGATROBAN HYDRATE 60MG: (B)(6) 2011. PRIOR TO IMPLANTING THE VRD, SLIMGUIDE/MEDIKIT, CHIKAI/ASAHI INTECC, PROWLER SELECT PLUS MICROCATHETER (606-S255X/LOT#UNKNOWN) WERE UTILIZED. OTHER DEVICES UTILIZED DURING THE PROCEDURE WERE, EXCELSIOR SL10/STRYKER, CHIKAI/ASAHI INTECC, TRANSEND EX/STRYKER, 637CF0925(LOT# UNKNOWN), 637CF0721(LOT# UNKNOWN), CDF100515-30(LOT# UNKNOWN), GDC/STRYKER(TOTAL2), ED/KANEKA(TOTAL5), 640CX2535(LOT# UNKNOWN), 640CX3575(LOT# UNKNOWN)(TOTAL3), 640CX0306(LOT# UNKNOWN). NO FURTHER INFORMATION IS AVAILABLE AND PROCEDURAL IMAGES ARE NOT AVAILABLE. THE PRODUCT REMAINS IMPLANTED AND IS NOT AVAILABLE FOR ANALYSIS, ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT AFTER FURTHER REVIEW OF THE FILE, THE EVENT DOES NOT MEET THE CRITERIA FOR REPORTING. THEREFORE, NO FURTHER INFORMATION WILL BE SUBMITTED FOR THIS REPORT.

    Description of Event or Problem · 1

    THE REPORT FROM CLINICAL STUDY (B)(4) FOR PATIENT WITH ID# (B)(6) INDICATED THAT THE PROCEDURE WAS COIL EMBOLIZATION ASSISTED WITH AN ENTERPRISE VRD (ENC452812/01425457) OF THE RIGHT CAVERNOUS SINUS, AND DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED GREAT DIFFICULTIES IN DELIVERING AND PLACING THE GUIDING 6FR/95CM SLIM GUIDE CATHETER (MEDIKIT) IN THE VERTEBRAL ARTERY, BUT EVENTUALLY THE GUIDING CATHETER WAS PLACED. HOWEVER, THE PATIENT COMPLAINED OF A LEFT-SIDED PARALYSIS AND GAIT DISORDER ASSOCIATED WITH CONVERGENCE INSUFFICIENCY, THEREFORE, THE PROCEDURE WAS CONTINUED UNDER MILD SEDATION. WHEN THE PROCEDURE WAS COMPLETED, MRI REVEALED CEREBELLAR INFARCTION AS WELL AS MEDULLARY INFARCT. ACTION TAKEN WAS ADMINISTRATION OF EDARAVONE. OTHER THAN WHAT WAS REPORTED, THERE WERE NO OTHER COMPLICATIONS DURING THE PROCEDURE THAT MAY HAVE CONTRIBUTED TO THE EVENT. THERE WAS NO SPASM NOTED AT THE SITE. AFTER THE COILS WERE PLACE, NO COILS PROTRUDE FROM THE TARGET ANEURYSM, AND THERE WAS NO THROMBUS PRESENT DURING INITIAL ANGIOGRAPHY. DURING THE EVENT, THE ENTERPRISE STENT WAS PATENT, AND THE ENTERPRISE STENT WAS FULLY EXPANDED, APPOSED TO THE VESSEL WALL AND IN A STABLE POSITION. THE EVENT OUTCOME AS OF FOUR MONTHS FROM ONSET WAS ONGOING, IMPROVED. ACCORDING TO THE PHYSICIAN, THE POSSIBLE CAUSE OF THE EVENT WAS BECAUSE THE PROCEDURE WAS CONTINUED WHILE THE CATHETER WAS WEDGED. THE RELATIONSHIP OF THE EVENT TO THE PROCEDURE WAS HIGHLY PROBABLE AND TO THE VRD WAS UNKNOWN. THE PATIENT HAS A MEDICAL HISTORY OF HYPERGLYCEMIA. THE UNRUPTURED SACCULAR ANEURYSM NECK WAS 6.0MM, AND THE NECK TO SAC RATIO WAS 6.0MM: 11.0MM. THE PARENT VESSEL SIZE DIAMETER PROXIMAL WAS 3.1MM AND DISTALLY WAS 2.8MM. MRS ON (B)(6) 2011 WAS 1, ON (B)(6) 2011 WAS 4, AND ON (B)(6) 2011 WAS 2. THE ACT WAS 160 SECONDS PRE ANTICOAGULATION AND 275 SECONDS POST ANTICOAGULATION. HEPARIN 12000U WAS ADMINISTERED INTRA-PROCEDURALLY. THE OCCLUSION RATE OF ANEURYSM WAS 95%.

    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 01425457

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention