BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2970331 · Received February 20, 2013

    Report

    Report Number
    2024168-2013-00997
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    January 30, 2013
    Report Date
    January 30, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 EVALUATION. THE STENT DAMAGE WAS CONFIRMED. THE FAILURE TO ADVANCE/CROSS COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. THE GUIDING CATHETER RESISTANCE WAS NOT CONFIRMED BASED ON VISUAL, FUNCTIONAL 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 THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT CORONARY ARTERY WITH MODERATE TORTUOSITY AND HEAVY CALCIFICATION. THE 2.0 X 20 MM MINI TREK BALLOON CATHETER WAS ADVANCED, BUT COULD NOT CROSS TO THE LESION DUE TO THE ANATOMY. AN UNKNOWN BALLOON WAS USED. THE 3.5 X 18 MM XIENCE XPEDITION STENT DELIVERY SYSTEM (SDS) WAS THEN ADVANCED, BUT COULD NOT CROSS TO THE LESION. DURING REMOVAL, SLIGHT RESISTANCE WAS NOTED WITH THE GUIDING CATHETER. AFTER REMOVAL, IT WAS NOTED THAT THE STENT STRUT WAS FLARED. A NEW 3.5 X 18 MM XIENCE XPEDITION SDS WAS USED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74150 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2101841

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR GUIDE CATH: MEDTRONIC