BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 4211854 · Received October 29, 2014

    Report

    Report Number
    2024168-2014-07106
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    October 7, 2014
    Report Date
    October 7, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE TWISTED AND STRETCHED SHAFT WAS UNABLE TO BE CONFIRMED. THE DIFFICULTY REMOVING THE DEVICE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON A VISUAL, DIMENSIONAL, AND FUNCTIONAL 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. A QUERY/REVIEW OF THE COMPLAINT DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED. THE XIENCE ALPINE IS BEING FILED UNDER A SEPARATE MANUFACTURING REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY TORTUOUS RIGHT CORONARY ARTERY (RCA) AND A MODERATELY TORTUOUS CIRCUMFLEX (CX) ARTERY. AFTER PRE-DILATATION WITH AN UNKNOWN BALLOON CATHETER, A 2.5 X 12 MM XIENCE ALPINE STENT WAS SUCCESSFULLY IMPLANTED IN THE RCA. THERE WAS A "DRAG" FELT AND THERE WAS RESISTANCE WHEN REMOVING THE CATHETER. IT IS UNKNOWN WHAT THE RESISTANCE WAS WITH. AS THE CATHETER WAS BEING REMOVED, THE PHYSICIAN STATED IT FELT AS IF THE CATHETER WAS STRETCHING. ONCE REMOVED FROM THE ANATOMY, THE DISTAL SHAFT HAD STRETCHED AND WAS IN A CORKSCREW SHAPE. AFTER PRE-DILATATION OF THE CIRCUMFLEX ARTERY WITH AN UNKNOWN BALLOON CATHETER, A 3.0 X 12 MM XIENCE ALPINE WAS SUCCESSFULLY IMPLANTED. THERE WAS ALSO RESISTANCE REMOVING THE DEVICE AND OUT OF THE ANATOMY, THE DISTAL SHAFT HAD STRETCHED AND WAS ALSO IN A CORKSCREW SHAPE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AT THIS TIME. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692821 XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 4070441

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR