BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2863328 · Received December 10, 2012

    Report

    Report Number
    2024168-2012-07750
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 14, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). USE AFTER EXPIRATION IT IS INDICATED THAT THE DEVICE IS NOT RETURNING, THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE PERFORMED. HOWEVER, A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES WITH THE REPORTED LOT AND A REVIEW OF THE COMPLAINT HISTORY DID NOT INDICATE A MANUFACTURING ISSUE. IT SHOULD BE NOTED THAT THE XIENCE V/XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) INSTRUCTS THE PHYSICIAN TO: NOTE THE USE-BY (EXPIRATION) DATE ON THE PRODUCT LABEL. ADDITIONALLY, THE IFU STATES: DO NOT USE AFTER THE USE-BY (EXPIRATION) DATE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    REPORTEDLY DURING THE PROCEDURE ON (B)(6) 2012, A 3.0 X 08 MM XIENCE V STENT WAS IMPLANTED IN THE DISTAL RIGHT CORONARY ARTERY. AFTER THE STENT WAS IMPLANTED, IT WAS NOTED THAT THE LABEL OF THE DEVICE INDICATED THAT THE EXPIRATION DATE OF THE DEVICE WAS (B)(6) 2012. PER REPORT, THE CASE WAS CHALLENGING DUE TO THE PATIENT ANATOMY, BUT THERE WERE NO ADVERSE PATIENT EFFECTS AND NO DEVICE MALFUNCTION NOTED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY. 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 0062241

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR