BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 3196707 · Received June 28, 2013

    Report

    Report Number
    2024168-2013-04065
    Event Type
    Injury
    Date Received
    June 28, 2013
    Date of Event
    June 3, 2013
    Report Date
    June 3, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED. THE EMBOSHIELD NAV6 REFERENCED IS BEING FILED UNDER SEPARATE A MANUFACTURING REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN EMBOSHIELD NAV 6 EMBOLIC PROTECTION SYSTEM (EPS) WAS PLACED IN A MILDLY TORTUOUS, MODERATELY CALCIFIED, LEFT INTERNAL CAROTID ARTERY AND AN ACCULINK STENT WAS SUCCESSFULLY IMPLANTED TO THE LESION. AS THE ACCULINK STENT DELIVERY SYSTEM (SDS) WAS BEING REMOVED, THE BARE WIRE OF THE EPS WAS PULLED AND THE EMBOSHIELD NAV 6 FILTER WAS PULLED PROXIMALLY. THE SDS BECAME ENTANGLED WITH THE EMBOSHIELD NAV 6 FILTER. ANOTHER UNSPECIFIED GUIDE WIRE WAS ADVANCED THROUGH THE ACCULINK IMPLANTED STENT DISTAL TO THE EMBOSHIELD NAV 6 EPS AND A NON-ABBOTT FILTER WAS PLACED. AT THIS POINT THE EMBOSHIELD NAV 6 FILTER CAME OFF OF THE SDS. THE SDS WAS REMOVED AND THE FILTER WAS SUCCESSFULLY CAPTURED AND REMOVED WITH AN UNSPECIFIED RECOVERY SYSTEM. THE PROCEDURE WAS COMPLETED WITH THE NON-ABBOTT FILTER IN PLACE AND THERE WAS NO ADVERSE PATIENT EFFECT OR NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296563 RX ACCULINK CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM AV-TEMECULA-CT 3012361

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention EMBOSHIELD NAV 6 EMBOLIC PROTECTION