BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 2890314 · Received December 29, 2012

    Report

    Report Number
    1058196-2012-00465
    Event Type
    Malfunction
    Date Received
    December 29, 2012
    Date of Event
    December 13, 2012
    Report Date
    December 17, 2012
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WILL NOT BE RETURNED FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS.

    Additional Manufacturer Narrative · 1

    DURING TREATMENT OF AN ANTERIOR COMMUNICATING (ACOM) ARTERY ANEURYSM THE ENTERPRISE STENT (ENC452812/ 10086765) COULD NOT BE DEPLOYED WITH ATTEMPT TO WITHDRAW THE PROWLER SELECT PLUS (606S255X/ 15638603) AFTER IT WAS POSITIONED ACROSS THE NECK OF THE ANEURYSM. THEREFORE, AN ATTEMPT WAS MADE TO WITHDRAW THE STENT, BUT FRICTION WAS ENCOUNTERED SO THE STENT AND MICROCATHETER HAD TO BE WITHDRAWN TOGETHER. THE DEVICES WERE EXCHANGED FOR ANOTHER ENTERPRISE (LOT 10086765) AND PROWLER SELECT PLUS (LOT 15638603) TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY. THE MICRO-CATHETER TIP WAS NOT RE-SHAPED. THE VESSEL WAS NOT TORTUOUS. THE 5X6.5MM ANEURYSM HAD A 4MM WIDE NECK. A CONSTANT SALINE FLUSH WAS MAINTAINED. NO EXTRA HEAT SOURCE WAS USED. THERE WAS NO RESISTANCE/FRICTION DURING ADVANCEMENT OF THE ENTERPRISE INTO THE MICROCATHETER. NO DAMAGE WAS FOUND WHEN THE PRODUCT WAS REMOVED FROM THE PACKAGE. THE PATIENT HAD CONTAGIOUS DISEASE, SO THE PRODUCT WAS DISCARDED AND COULD NOT BE RETURNED BACK. LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 10086765. THE DEVICE HISTORY RECORD REVIEW ALSO INCLUDED A REVIEW OF THE CERTIFICATE OF CONFORMANCE RECEIVED FROM SPECIALTY COATINGS SYSTEMS AND NITINOL DEVICES AND COMPONENTS, 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.

    Description of Event or Problem · 1

    THE PATIENT CAME IN WITH ACOM ANEURYSM SIZED 5X6.5MM, THE NECK WIDTH WAS 4MM. DURING THE PROCEDURE, THE STENT COULD NOT BE DEPLOYED, SO THE PHYSICIAN WITHDREW THE STENT BUT FELT FRICTION, SO HE HAD TO WITHDRAW THE STENT AND THE MICROCATHETER TOGETHER. THE STENT WAS REPLACED WITH ENC452212 STENT (LOT 10086765) AND PROWLER SELECT PLUS (LOT 15638603) TO COMPLETE THE PROCEDURE. THE MICROCATHETER TIP WAS NOT RE-SHAPED. THE VESSEL WAS NOT TORTUOUS. A CONSTANT SALINE FLUSH WAS MAINTAINED. NO EXTRA HEAT SOURCE. NO DAMAGE WAS FOUND WHEN THE PRODUCT WAS REMOVED FROM THE PACKAGING. THE PATIENT HAD CONTAGIOUS DISEASE, SO THE PRODUCT WAS DISCARDED AND COULD NOT BE RETURNED BACK.

    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 10086765

    Patients

    Seq Age Sex Outcome Treatment
    1 PROWLER SELECT PLUS, LOT 15638603