BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 2403376 · Received January 8, 2012

    Report

    Report Number
    1058196-2012-00006
    Event Type
    Injury
    Date Received
    January 8, 2012
    Date of Event
    December 14, 2011
    Report Date
    December 14, 2011
    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

    DURING AN ENTERPRISE VRD STENT ASSISTED COIL EMBOLIZATION, AN ANGIOGRAM DEMONSTRATED SOME THROMBUS THAT DISAPPEARED AFTER A SHORT TIME. THE PATIENT WAS ASYMPTOMATIC AND NO INTERVENTION WAS PERFORMED AS A RESULT. THE TARGET LESION WAS AN ANEURYSM OF THE MIDDLE CEREBRAL ARTERY AT THE BIFURCATION OF THE M1-M2 SEGMENT. THE TARGET LESION WAS NOT CALCIFIED OR TORTUOUS. THERE IS NO INFORMATION REGARDING THE ANEURYSM/PARENT VESSEL CHARACTERISTICS OR ANTIPLATELET THERAPY. THERE WAS NO REPORTED PRODUCT ISSUE WITH THE ENTERPRISE VRD OR DELIVERY SYSTEM OR WITH ANY ADDITIONAL EQUIPMENT USED. NO ADDITIONAL INFORMATION IS AVAILABLE. THE DEVICE REMAINS IMPLANTED AND PROCEDURAL IMAGES ARE NOT AVAILABLE FOR EVALUATION. THE PRODUCT WAS NOT RETURNED FOR INSPECTION. NOTE: CORDIS LOT # 10010226 IS LAKE REGION LOT # 10010226. PER LAKE REGION REPORT (B)(4): LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 10010226. 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. THIS PACKAGING LOT CONTAINED 50 UNITS, WHICH WERE SHIPPED FROM LAKE REGION MEDICAL ON MAY 10, 2011. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. THROMBOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF THE CORDIS ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM AS OUTLINED IN THE INSTRUCTIONS FOR USE. BASED ON THE LACK OF CLINICAL/PROCEDURAL INFORMATION NO CONCLUSION CAN BE MADE REGARDING POSSIBLE PATIENT, PROCEDURAL OR PHARMACOLOGICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THE EVENT. THERE IS NO INDICATION OF ANY DEVICE PERFORMANCE OR MANUFACTURING ISSUES RELATED TO THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    SUPERSHEATH/MEDIKIT, ROADMASTER/GOODMAN, AND EXCELSIOR SL10/STRYKER. THE DEVICE REMAINS IMPLANTED IN THE PATIENT AND IS NOT AVAILABLE FOR INSPECTION. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT DURING A STENT ASSISTED COIL EMBOLIZATION, THE PHYSICIAN DEPLOYED AN ENTERPRISE VRD AND DELIVERY STENT. DURING THE PROCEDURE, AN ANGIOGRAM DEMONSTRATED SOME THROMBUS THAT DISAPPEARED AFTER A SHORT TIME. THE PATIENT WAS ASYMPTOMATIC AND NO INTERVENTION WAS PERFORMED AS A RESULT. THE TARGET LESION WAS AN ANEURYSM OF THE MID CEREBRAL ARTERY AT THE BIFURCATION OF THE M1-M2 SEGMENT. THE TARGET LESION WAS NOT CALCIFIED OR TORTUOUS. THERE WAS NO REPORTED PRODUCT ISSUE WITH THE ENTERPRISE VRD AND DELIVERY STENT OR WITH ANY ADDITIONAL EQUIPMENT USED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    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 Life Threatening