BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3024224 · Received March 27, 2013

    Report

    Report Number
    2024168-2013-01772
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    February 28, 2013
    Report Date
    March 6, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. (B)(4): EXCESSIVE FORCE. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. FAILURE TO CROSS AND PHYSICAL RESISTANCE IN THE LESION COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. SHAFT KINK WAS CONFIRMED. STENT MOVEMENT/LOOSE STENT WAS NOT 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 THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED 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 ON (B)(6) 2013, THE PATIENT UNDERWENT A STENTING PROCEDURE IN THE HEAVILY CALCIFIED AND TORTUOUS RIGHT CORONARY ARTERY (RCA). PRE-DILATATION WAS PERFORMED USING AN UNSPECIFIED DILATATION CATHETER. THE 3.0 X 12 MM XIENCE XPEDITION STENT DELIVERY SYSTEM WAS ADVANCED INTO THE PATIENT ANATOMY AND RESISTANCE WAS FELT DUE TO THE PATIENT ANATOMY. FORCE WAS APPLIED AND THE STENT WAS NOTED TO SLIP OFF THE MARKERS TOWARDS THE SHAFT OF THE DELIVERY SYSTEM; HOWEVER, THE STENT REMAINED ON THE BALLOON OF THE DELIVERY SYSTEM. THE SHAFT OF THE STENT DELIVERY SYSTEM BECAME KINKED. THE DEVICE WAS REMOVED WITHOUT RESISTANCE AND THE STENT REMAINED ON THE DELIVERY SYSTEM. ADDITIONAL PRE-DILATATION WAS PERFORMED AND A SECOND SAME SIZE XIENCE XPEDITION WAS DEPLOYED WITHOUT DIFFICULTY. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126554 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2092641

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR