BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3885048 · Received June 19, 2014

    Report

    Report Number
    2024168-2014-03966
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 26, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: GUIDE WIRE: SION BLUE, JOKER; GUIDE CATHETER: TAIGA 7FR EBU35. THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED HUB LEAK WAS NOT CONFIRMED; HOWEVER, THERE WAS A TEAR/LEAK IN THE SHAFT. 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 ELECTRONIC COMPLAINT HANDLING DATABASE REVEALED NO OTHER INCIDENTS FOR LEAKS OR SHAFT DAMAGE/TORN MATERIAL 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 A STENTING PROCEDURE OF A 23MM LONG CONCENTRIC, DE NOVO LESION IN A MODERATELY CALCIFIED, MODERATELY TORTUOUS, 90% STENOSED , PROXIMAL AND MID PORTIONS OF THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY, AFTER PLACEMENT OF TWO NON-ABBOTT GUIDE WIRES AND LESION PRE-DILATATION, A XIENCE XPEDITION STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION. PRIOR TO THE BALLOON INFLATION BLOOD WAS OBSERVED INSIDE THE DEVICE BETWEEN THE HUB AND INFLATION DEVICE. THE DEVICE WAS REMOVED AND ANOTHER XIENCE XPEDITION 3.0X23MM SDS WAS DEPLOYED SUCCESSFULLY. TO COMPLETE THE PROCEDURE, THE STENT WAS POST-DILATED WITH AN UNSPECIFIED BDC. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELA AND NO REPORTED SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362060 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 4021941

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR CONCOMITANT MEDICAL DEVICES