BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 1915175 · Received December 6, 2010

    Report

    Report Number
    1058196-2010-00358
    Event Type
    Injury
    Date Received
    December 6, 2010
    Date of Event
    August 12, 2010
    Report Date
    November 9, 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

    CONCOMITANT PRODUCTS: CHIKAI GUIDEWIRE, LAUNCHER GUIDING CATHETER, ECHELON, PROWLER SELECT PLUS MICRO-CATHETER. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE. PLEASE REFERENCE MFR REPORT # 1058196-2010-00357.

    Additional Manufacturer Narrative · 1

    INFORMATION WAS RECEIVED VIA THE (B)(6) THAT THE DAY AFTER AN UNEVENTFUL ENTERPRISE VRD ASSISTED COIL EMBOLIZATION, THE PATIENT HAD AN ASYMPTOMATIC CEREBRAL INFARCTION BASED ON IMAGING RESULTS. THE PATIENT WAS ASYMPTOMATIC AND NO TREATMENT WAS PERFORMED. THE PHYSICIAN COMMENTED THAT IT WAS NOT KNOWN IF THE EVENT WAS CAUSED BY THE CATHETER MANIPULATION OR THE ENTERPRISE VRD DEVICE. THE PATIENT WAS REPORTED TO BE CURRENTLY IN STABLE CONDITION. THE INDEX PROCEDURE WAS FOR A COIL EMBOLIZATION OF A CEREBRAL ANEURYSM ASSISTED BY IMPLANTATION OF AN ENTERPRISE VRD STENT. NO TARGET LESION INFORMATION IS AVAILABLE. OTHER IDENTIFIED DEVICES USED DURING THE PROCEDURE INCLUDE A NONCORDIS (CHIKAI) LAUNCHER GUIDING CATHETER, PROWLER SELECT PLUS MICROCATHETER, AND NONCORDIS ECHELON MICROCATHETER WERE USED DURING THE PROCEDURE. THERE IS NO FURTHER PROCEDURAL INFORMATION AVAILABLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY REPORTED PROBLEMS. THERE WERE NO REPORTED PRODUCT ISSUES, PROCEDURAL COMPLICATIONS OR ADVERSE EVENTS DURING THE PROCEDURE. THE PATIENT HAD NO NEUROLOGICAL DEFICIT UPON LEAVING THE ANGIOGRAPHY SUITE. THE DAY AFTER THE PROCEDURE, THE PATIENT WAS FOUND TO HAVE TWO SPOTS OF PUNCTUATE HIGH INTENSITY AREAS (HIA) IN THE LEFT OCCIPITAL LOBE. IT WAS REPORTED AS AN ASYMPTOMATIC CEREBRAL INFARCTION. THE ENTERPRISE VRD REMAINS IMPLANTED AND THE PROWLER MICROCATHETER IS NOT AVAILABLE FOR ANALYSIS. (B)(4) REVIEWED THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01419843 WHICH CORRESPONDS TO FINAL LOT 13471872. THE DEVICE HISTORY RECORD REVIEW ALSO INCLUDED A REVIEW OF THE CERTIFICATE OF CONFORMANCE RECEIVED FROM (B)(4), ALONG WITH (B)(4) INTERNAL RECEIVING INSPECTION RECORDS FOR THE STENTS ISSUED TO THE COMPLAINT LOT. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT (B)(4) AND WAS DETERMINED TO BE ACCEPTABLE. CEREBRAL INFARCTION (STROKE) IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THIS TYPE OF PROCEDURE AS OUTLINED IN THE INSTRUCTIONS FOR USE. BASED ON THE REPORTED INFORMATION IT IS NOT POSSIBLE TO DRAW A CONCLUSION REGARDING THE CLINICAL RELATIONSHIP BETWEEN THE DEVICES AND THE EVENT. PATIENT, PROCEDURAL, AND PHARMACOLOGICAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. THERE IS NO INDICATION OF A RELATIONSHIP TO ANY DEVICE DESIGN, PERFORMANCE, OR MANUFACTURING ISSUES. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE. PLEASE REFERENCE MFR. REPORT # 1058196-2010-00357 AND # 1058196-2010-00358.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT THE PATIENT WAS ENROLLED IN A CLINICAL STUDY "(B)(6)". THE INDEX PROCEDURE WAS FOR A COIL EMBOLIZATION OF A CEREBRAL ANEURYSM ASSISTED BY IMPLANTATION OF AN ENTERPRISE VRD STENT. NO TARGET LESION INFORMATION WAS AVAILABLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY REPORTED PROBLEMS. THERE WERE NO REPORTED PRODUCT ISSUES, PROCEDURAL COMPLICATIONS OR ADVERSE EVENTS DURING THE PROCEDURE. THE PATIENT HAD NO NEUROLOGICAL DEFICIT UPON LEAVING THE ANGIOGRAPHY SUITE. THE DAY AFTER THE PROCEDURE, THE PATIENT WAS REPORTED TO HAVE EXPERIENCED AN ASYMPTOMATIC CEREBRAL INFARCTION. THE PATIENT WAS FOUND TO HAVE TWO SPOTS OF HIGH INTENSITY AREAS (PUNCTUATE HIA) IN THE LEFT OCCIPITAL LOBE. THE PATIENT WAS ASYMPTOMATIC AND NO TREATMENT WAS PERFORMED. THE PHYSICIAN COMMENTED THAT IT WAS NOT KNOWN IF THE EVENT WAS CAUSED BY THE CATHETER MANIPULATION OR THE ENTERPRISE VRD DEVICE. THE PATIENT WAS REPORTED TO BE CURRENTLY IN STABLE CONDITION.

    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. 13471872

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR