BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3090599 · Received May 2, 2013

    Report

    Report Number
    2024168-2013-02727
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 20, 2013
    Report Date
    April 22, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN 80% STENOSED LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY WITH HEAVY TORTUOSITY AND HEAVY CALCIFICATION. PRE-DILATATION WAS PERFORMED AND THE 3.0 X 28 MM XIENCE V STENT DELIVERY SYSTEM (SDS) WAS ADVANCED, BUT AFTER MULTIPLE ATTEMPTS, THE SDS COULD NOT CROSS THE LESION AND IT WAS NOTED THAT THE STENT STRUT WAS FRACTURED. THE DEVICE WAS REMOVED AND IT WAS CONFIRMED THAT NO PORTION OF THE STENT STRUT REMAINED IN THE ANATOMY. A 3.0 X 18 MM XIENCE V SDS WAS ADVANCED WITH SOME RESISTANCE, BUT WAS ABLE TO CROSS THE LESION. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192363 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2110641

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR GUIDE WIRE: BMW UNIVERSAL 190CM