BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2941361 · Received February 4, 2013

    Report

    Report Number
    2024168-2013-00597
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 10, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 RESISTANCE DURING ADVANCEMENT AND WITHDRAWAL COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. 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 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 DURING A PROCEDURE OF THE MILDLY CALCIFIED, HEAVILY TORTUOUS CIRCUMFLEX ARTERY, AFTER PREDILATATION WITH A 2.5 X 12 MM NON-ABBOTT BALLOON DILATATION CATHETER (BDC), THE 2.5 X 33 MM XIENCE XPEDITION STENT DELIVERY SYSTEM (SDS) WAS FORCEFULLY ADVANCED AGAINST THE RESISTANCE AND THE DISTAL STENT STRUT BECAME FLARED. THE DEVICE WAS REMOVED FROM THE ANATOMY WITHOUT ISSUE. ADDITIONAL PREDILATATION WAS PERFORMED AND A 6 FR GUIDE LINER CATHETER WAS USED WITH A SECOND XIENCE XPEDITION SDS BUT IT WOULD NOT ADVANCE IN THE GUIDE LINER CATHETER AND BECAME STUCK AT THE PROXIMAL END. AFTER REMOVAL IT WAS NOTED THAT THE SDS STENT STRUT WAS FLARED. A THIRD 2.5 X 33 XIENCE XPEDITION SDS WAS USED WITH THE SAME GUIDE LINER CATHETER AND WAS SUCCESSFULLY DEPLOYED WITHOUT ISSUE. 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
    47204 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2082041

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR GUIDE CATH: 6 FROTHER: 6 FR GUIDE LINER