BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3900548 · Received June 27, 2014

    Report

    Report Number
    2024168-2014-04178
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 5, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED STENT DISLODGMENT WAS CONFIRMED. BASED ON VISUAL AND DIMENSIONAL 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 ELECTRONIC COMPLAINT HANDLING DATABASE REVEALED NO OTHER INCIDENTS FOR STENT DISLODGMENT 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 DURING PREPARATION OF THE 3.5 X 33 MM XIENCE XPEDITION STENT, THE STENT IMPLANT DISLODGED DURING REMOVAL OF THE PROTECTIVE SHEATH. THERE WAS NO RESISTANCE DURING THE REMOVAL OF THE PROTECTIVE SHEATH. THE DEVICE WAS NOT USED ON THE PATIENT. ANOTHER 3.5 X 33 MM XIENCE XPEDITION STENT WAS SELECTED. HOWEVER, IT FAILED TO CROSS THE LESION IN THE RIGHT CORONARY ARTERY (RCA) WITH MODERATE TORTUOSITY AND 90% STENOSIS, DUE TO RESISTANCE WITH THE ANATOMY. A NON-ABBOTT 3.5 X 32 MM STENT CROSSED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY OF PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377840 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 4012741

    Patients

    Seq Age Sex Outcome Treatment
    1