BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3062027 · Received April 16, 2013

    Report

    Report Number
    2024168-2013-02340
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 19, 2013
    Report Date
    March 21, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE STENT DISLODGEMENT WAS UNABLE TO BE CONFIRMED HOWEVER FOLLOW UP INFORMATION RECEIVED NOTED THAT THE STENT WAS INTENTIONALLY PLACED BACK ON THE BALLOON. THE FIBERS NOTED ON THE STENT STRUTS DURING DEVICE EVALUATION WERE LIKELY DUE TO HANDLING WHEN THE SITE PLACED THE STENT BACK ON THE BALLOON POST-PROCEDURE. THE FAILURE TO ADVANCE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON A VISUAL AND DIMENSIONAL INSPECTION 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 REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE ADVANCING A 2.25X18 XIENCE XPEDITION RX STENT DELIVERY SYSTEM (SDS) TOWARD A MODERATELY CALCIFIED LESION IN THE MID RIGHT CORONARY ARTERY (RCA) TO PERFORM DIRECT STENTING, THOUGH SLIGHT FORCE WAS APPLIED DURING THE ATTEMPT TO CROSS, THE XPEDITION SDS WAS UNABLE TO CROSS THE LESION DUE TO PATIENT ANATOMY. THE XIENCE XPEDITION SDS WAS WITHDRAWN FROM THE ANATOMY WITHOUT RESISTANCE. THE LESION WAS THEN PRE-DILATED WITH A 2.0X10 NON-ABBOTT BALLOON DILATATION CATHETER. PRIOR TO RE-INTRODUCING THE XIENCE XPEDITION SDS INTO THE PATIENT ANATOMY, IT WAS NOTED THAT THE STENT HAD DISLODGED PROXIMALLY ONTO THE SHAFT. A 2.25X23 XIENCE XPEDITION RX SDS WAS USED SUCCESSFULLY TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO OCCURRENCE OF A CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED. THE ABBOTT VASCULAR RETURNED GOODS LAB RECEIVED THE DEVICE WITH THE BALLOON SHIFTED DISTALLY ON THE BALLOON, BUT NOT DISLODGED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE STENT WAS INTENTIONALLY PUSHED BACK ONTO THE BALLOON (FROM ITS ORIGINAL PROXIMAL DISLODGED STATE) DURING REPACKAGING FOR RETURN SHIPMENT. ADDITIONALLY, THERE WERE UNKNOWN FIBERS NOTED ON THE DISTAL STRUTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162617 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2102241

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR