BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 2327665 · Received November 8, 2011

    Report

    Report Number
    1058196-2011-00491
    Event Type
    Malfunction
    Date Received
    November 8, 2011
    Date of Event
    September 28, 2011
    Report Date
    October 4, 2011
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ONE NON STERILE ENTERPRISE WAS RECEIVED TANGLED AND COILED INSIDE OF A PLASTIC BAG. THE ENTERPRISE WAS RECEIVED INSIDE THE INTRODUCER. THE STENT WAS RECEIVED DEPLOYED AND ATTACHED IN A SMALL PLASTIC BAG INSIDE THE BIG ONE. THE DELIVERY WIRE AND INTRODUCER PRESENTED NO DAMAGE. THE COIL WAS FOUND STRETCHED FROM 30.0 CM TO 35 CM FROM THE DISTAL END. A WAVY CONDITION WAS FOUND ON THE COIL FROM 6.0CM TO 26.5CM FROM DISTAL END. NO OTHER VISUAL ANOMALIES WERE OBSERVED. THE FUNCTIONAL TEST COULD NOT BE PERFORMED BECAUSE THE RECEIVED CONDITIONS OF THE PRODUCT (THE STENT WAS RECEIVED DEPLOYED). THE STENT ENTERPRISE WAS INSPECTED UNDER MICROSCOPE AND NO ANOMALIES WERE FOUND. PER LAKE REGION REPORT (B)(4): LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 10020149. 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. THE FAILURE REPORTED BY THE COSTUMER AS "STENT/ DEPLOYMENT DIFFICULTY-PREMATURE /DURING REMOVAL FROM HOOP" COULD NOT BE EVALUATED DUE TO THE RECEIVED CONDITIONS OF THE PRODUCT. THE ANALYSIS, THE PRODUCT CONDITIONS AND THE PROVIDED INFORMATION SUGGEST THAT PROCEDURAL FACTORS COULD BE IMPACTED ON THE FAILURE REPORTED BY THE COSTUMER, AS WELL AS THE WAVY/STRETCHED CONDITION FOUND ON THE COIL. THE DEVICE DID NOT PRESENT ANY OBVIOUS INDICATION OF MANUFACTURING DEFECT OR ANOMALY THAT COULD CONTRIBUTED TO THE EVENT AS REPORTED. NEITHER THE PRODUCT ANALYSIS NOR THE DHR REVIEW SUGGESTS THAT THE FAILURE COULD BE RELATED TO THE ENTERPRISE MANUFACTURING PROCESS; THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME. WITH THE LIMITED AMOUNT OF INFORMATION AVAILABLE IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT. HOWEVER, IN THIS CASE, IT IS POSSIBLE THAT THE DIFFICULTY EXPERIENCED BY THE CUSTOMER WAS RELATED TO PROCEDURAL FACTORS AND/OR USER HANDLING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO USE IN THE PATIENT, THE ENTERPRISE STENT (ENF452212/10020149) FELL OFF FROM THE TIP OF SHEATH DURING REMOVAL FROM THE PLASTIC HOOP. NO FURTHER INFORMATION WAS PROVIDED, HOWEVER THE ANALYSIS ON THE PRODUCT REVEALED THAT THE ENTERPRISE DELIVERY SYSTEM WAS UNRAVELED.

    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 10020149

    Patients

    Seq Age Sex Outcome Treatment
    1