BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2834262 · Received November 15, 2012

    Report

    Report Number
    2024168-2012-07217
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    October 20, 2012
    Report Date
    October 22, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    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. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE STENT DISLODGEMENT WAS UNABLE TO BE CONFIRMED HOWEVER FOLLOW UP INFORMATION RECEIVED CONFIRMED THE STENT WAS RE-POSITIONED ON THE BALLOON POST PROCEDURE. THE FAILURE TO ADVANCE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON A VISUAL AND DIMENSIONAL INSPECTION OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. 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 REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, A 2.5X28 XIENCE V RX STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TOWARD A CALCIFIED LESION IN THE NON-HEAVILY TORTUOUS, PROXIMAL RIGHT CORONARY ARTERY, HOWEVER, THE SDS FAILED TO CROSS THE LESION; WHILE NO FORCE WAS APPLIED, DURING THE ATTEMPT TO CROSS THE LESION THE STENT PARTIALLY DISLODGED PROXIMALLY FROM THE BALLOON. AS THE STENT DID NOT COMPLETELY DISLODGE, THE SDS (WITH STENT) WAS SIMPLY WITHDRAWN FROM THE ANATOMY WITHOUT RESISTANCE FELT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO OCCURRENCE OF A CLINICALLY SIGNIFICANT DELAY. ANOTHER XIENCE SDS WAS USED TO COMPLETE THE PROCEDURE. 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 1022241

    Patients

    Seq Age Sex Outcome Treatment
    1