BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE PRO LL EVEROLIMUS ELUTING RX CORONARY STENT SYSTEM

    MDR report key: 2950259 · Received February 8, 2013

    Report

    Report Number
    2024168-2013-00737
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 16, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE PRODUCT WAS RETURNED AND DEVICE ANALYSIS CONFIRMED THE REPORTED LEAK IN THE SHAFT. THERE WAS A TEAR FOUND IN THE SHAFT, THAT LEAKED WHEN THE DEVICE WAS PRESSURIZED. A LOT HISTORY REVIEW OF THE AFFECTED LOT INDICATED NO ASSOCIATED NONCONFORMANCE RECORDS. THE DEVICE WAS MANUFACTURED ACCORDING TO THE PROCESS/MANUFACTURING SPECIFICATIONS AND LOT RELEASE QUALITY CONTROL TESTING SHOWED NO DEVIATIONS TO THE SPECIFICATION. A REVIEW OF THE COMPLAINT HANDLING DATABASE INDICATED NO SIMILAR COMPLAINTS REPORTED FOR THIS LOT. BASED ON AN EXPANDED INVESTIGATION, IT WAS DETERMINED THAT THIS WAS AN ISOLATED EVENT AND WAS NOT REPRESENTATIVE OF THE ENTIRE LOT. THIS TYPE OF REPORTED EVENT WILL CONTINUE TO BE MONITORED PER LOCAL QUALITY SYSTEM PROCEDURES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MID RIGHT CORONARY ARTERY. PRE-DILATATION WAS PERFORMED AND THE 3.5 X 38 MM XIENCE PRO STENT DELIVERY SYSTEM (SDS) WAS ADVANCED WITHOUT ISSUE TO THE LESION. THE STENT WAS DEPLOYED AT AN UNKNOWN PRESSURE, BUT WAS NOT FULLY APPOSED TO THE VESSEL WALL. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE PREVIOUS MEDWATCH FILING, ADDITIONAL INFORMATION REPORTED THAT DURING DEPLOYMENT OF THE XIENCE PRO STENT, IT WAS OBSERVED THAT THE INDEFLATOR WAS NOT MAINTAINING PRESSURE. A NEW INDEFLATOR WAS USED, BUT THE SAME ISSUE OCCURRED. THE STENT HAD BEEN DEPLOYED AND THE SDS WAS REMOVED. THE DEVICE WAS CHECKED OUTSIDE THE ANATOMY, AND A LEAK WAS FOUND IN THE SDS SHAFT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53669 XIENCE PRO LL EVEROLIMUS ELUTING RX CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2100841

    Patients

    Seq Age Sex Outcome Treatment
    1