BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XACT CAROTID STENT SYSTEM

    MDR report key: 2083472 · Received May 10, 2011

    Report

    Report Number
    2024168-2011-03354
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 15, 2011
    Report Date
    April 15, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIM
    PMA / PMN Number
    P040038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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. THERE WAS NO PRODUCT DEFICIENCY REPORTED. THE PRODUCT AND ITS PACKAGING WERE NOT RETURNED; THEREFORE THE EXPIRATION DATE ON THE SPECIFIC PRODUCT LABELS COULD NOT BE CONFIRMED. HOWEVER, A REVIEW OF THE LABELS ATTACHED TO THE LOT HISTORY RECORD FOR THIS LOT WAS CONDUCTED AND ALL LABELS INDICATED AN EXPIRATION DATE OF (USE BY DATE) OF (B)(6) 2011. THIS CONFIRMS THAT THE PRODUCT WAS LABELED CORRECTLY AND BASED ON THE REPORTED INFORMATION; THE PRODUCT WAS USED 15 DAYS PAST THE LABELED EXPIRATION DATE. THE EXPIRATION DATE OF THE PRODUCT IS IMPORTANT FOR THE STERILITY, EFFICACY AND PERFORMANCE OF THE DEVICE. THE XACT INSTRUCTIONS FOR USE STATES: DO NOT USE THE PRODUCT AFTER THE USE BY DATE SPECIFIED ON THE LABEL. A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS FOR THIS LOT AND THERE HAVE BEEN NO OTHER INCIDENTS FOR USE AFTER EXPIRATION REPORTED FOR THIS LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE XACT STENT, WITH AN EXPIRATION DATE OF (B)(6) 2011, WAS KNOWINGLY IMPLANTED IN THE LEFT INTERNAL CAROTID ARTERY ON (B)(6) 2011. THE PATIENT WAS ON THE TABLE WITH THE XACT STENT DELIVERY SYSTEM INSIDE THE ANATOMY, WHEN THE REALIZATION WAS MADE THAT THIS WAS AN EXPIRED DEVICE. THE STAFF CHECKED TO SEE IF THEY HAD ANOTHER PRODUCT THAT THEY COULD IMPLANT IN THE PATIENT, BUT THEY DID NOT HAVE ANY OTHER OPTIONS. THE PHYSICIAN DETERMINED THAT THE PROCEDURE COULD NOT BE ABORTED AT THAT POINT AND DID NOT FEEL THAT AN EXPIRED PRODUCT OF TWO WEEKS WOULD RESULT IN A DIFFERENT PATIENT OUTCOME. THE STENT WAS DEPLOYED ALTHOUGH IT WAS KNOWN THAT THE EXPIRATION DATE WAS EXCEEDED. REPORTEDLY THE CASE WENT OTHERWISE PERFECTLY WITHOUT DEVICE ISSUE. THERE WERE NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XACT CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM AV-TEMECULA-CT 526553

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR