BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2781557 · Received October 10, 2012

    Report

    Report Number
    2024168-2012-06412
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 11, 2012
    Report Date
    September 17, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE/PACKAGING IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE/PACKAGING COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED THAT THE REPORTED LOT WAS REWORKED TO EXTEND THE EXPIRATION DATE OF THE PRODUCT FROM (B)(6) 2012 TO (B)(6) 2013. LOT NUMBER 103084Y (ON THE CHIPBOARD BOX AND FOIL POUCH) IS THE REWORKED LABEL OF THE ORIGINAL LOT NUMBER 1030841 (ON THE TYVEK POUCH). A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FROM THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, ADDITIONAL INFORMATION INDICATES THAT THE STENT WAS A 2.25X15 RX XIENCE NANO. THE STENT WAS IMPLANTED IN THE RIGHT CORONARY ARTERY ON (B)(6) 2012. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND THE OVERALL OUTCOME OF THE PROCEDURE WAS SUCCESSFUL. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LOT NUMBER ON THE PACKAGING FOR THE XIENCE STENT DELIVERY SYSTEM DID NOT COINCIDE WITH THE LOT NUMBER ON THE STERILE POUCH. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 103084Y

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR