BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3875038 · Received June 16, 2014

    Report

    Report Number
    2024168-2014-03862
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 22, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE STENT REMAINS IN THE ANATOMY. THE STENT DELIVERY SYSTEM (SDS) WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE BALLOON REFOLD WAS CONFIRMED. THE INFLATION ISSUE WAS NOT CONFIRMED. BASED ON VISUAL AND FUNCTIONAL ANALYSIS 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 THIS COMPLAINT. A QUERY OF THE COMPLAINT HANDLING DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT USING A RADIAL ARTERY ACCESS APPROACH DURING A PROCEDURE OF THE CALCIFIED, OSTIAL LEFT MAIN ARTERY THE 4.0 X 8 MM XIENCE XPEDITION STENT DELIVERY SYSTEM (SDS) BALLOON WAS INFLATED ONCE AT 12 ATMOSPHERE (ATM) BUT DID NOT COMPLETELY INFLATE; IT WAS NOT POSSIBLE TO ACHIEVE OPTIMAL PRESSURE. THE STENT WAS SUCCESSFULLY IMPLANTED. THE BALLOON WAS DEFLATED. OUTSIDE THE ANATOMY IT WAS NOTED THE BALLOON APPEARED TO BE DEFLATED FLAT AND NOT REFOLDED. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353210 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 3111641

    Patients

    Seq Age Sex Outcome Treatment
    1