BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2121659 · Received June 13, 2011

    Report

    Report Number
    2024168-2011-04133
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 19, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 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 (USE BY DATE) OF 5/6/2011, WHICH IS 24 MONTHS FROM THE DATE OF MANUFACTURE (5/7/2009), AS SPECIFIED IN THE PRODUCT SPECIFICATION. THIS CONFIRMS THAT THE PRODUCT WAS LABELED CORRECTLY, AND BASED ON THE REPORTED INFORMATION THE PRODUCT WAS USED 6 DAYS PAST THE LABELED EXPIRATION DATE. THE XIENCE V INSTRUCTIONS FOR USE STATES: DO NOT USE AFTER THE USE BY DATE. THE EXPIRATION DATE OF THE PRODUCT IS IMPORTANT FOR THE STERILITY, EFFICACY AND PERFORMANCE OF THE DEVICE. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS INCIDENT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO SIMILAR INCIDENTS REPORTED FOR USE AFTER EXPIRATION FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. ALTHOUGH THE EXACT CAUSE OF WHY THE PRODUCT WAS USED AFTER EXPIRATION COULD NOT BE DETERMINED FROM THE REPORTED INFORMATION, IT APPEARS THAT USE ERROR LIKELY CONTRIBUTED TO THE REPORTED INCIDENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER IMPLANTING THE XIENCE V STENT IN A RIGHT CORONARY ARTERY LESION, IT WAS NOTED THAT THE EXPIRATION DATE WAS 6 DAYS PRIOR. THERE WAS NO ADVERSE PATIENT EFFECT. THE PATIENT OUTCOME WAS GOOD. 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 9042261

    Patients

    Seq Age Sex Outcome Treatment
    1