BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2853369 · Received November 30, 2012

    Report

    Report Number
    2024168-2012-07602
    Event Type
    Malfunction
    Date Received
    November 30, 2012
    Date of Event
    October 25, 2012
    Report Date
    November 5, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE SHAFT KINK AND SEPARATION WERE CONFIRMED. GUIDING CATHETER RESISTANCE WAS NOT CONFIRMED. BASED ON VISUAL, DIMENSIONAL, 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 THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. IT SHOULD BE NOTED THAT THE XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE STATES: SHOULD UNUSUAL RESISTANCE BE FELT AT ANY TIME, THE STENT DELIVERY SYSTEM AND THE GUIDE CATHETER SHOULD BE REMOVED AS A SINGLE UNIT. FAILURE TO FOLLOW THESE STEPS AND/OR APPLYING EXCESSIVE FORCE TO THE DELIVERY SYSTEM CAN POTENTIALLY RESULT IN LOSS OR DAMAGE TO THE STENT AND/OR DELIVERY SYSTEM COMPONENTS. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. CONCOMITANT MEDICAL DEVICE: GUIDE CATH: 6F NON-ABBOTT. (B)(4) - EXCESSIVE FORCE. THE DEVICE HAS BEEN RETURNED FOR INVESTIGATION. THE INVESTIGATION IS NOT COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. XIENCE XPEDITION IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE US.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A NARROW AND HEAVILY CALCIFIED DISTAL CIRCUMFLEX ARTERY. THERE WERE DIFFICULTIES PLACING A GUIDING CATHETER. ATTEMPTS WERE MADE TO PLACE FOUR (4) NON-ABBOTT GUIDING CATHETERS; HOWEVER, THEY COULD NOT BE PLACED. A 5TH NON-ABBOTT GUIDING CATHETER COULD FINALLY BE PLACED. A 3.0 X 15 MM TREK BALLOON CATHETER WAS SUCCESSFULLY USED FOR PRE-DILATATION. THERE WERE MULTIPLE INFLATIONS UP TO 13 ATMOSPHERES. A 3.0 X 18 MM XIENCE XPEDITION STENT DELIVERY SYSTEM (SDS) WAS ADVANCED THROUGH THE GUIDING CATHETER, BUT FROM THE TIME THE SDS ENTERED THE GUIDING CATHETER THERE WAS RESISTANCE AND THE SDS STUCK IN THE GUIDING CATHETER. THE PHYSICIAN APPLIED FORCE ON THE SDS AND THE HYPOTUBE KINKED. THE SDS WAS RETRACTED WITH SOME RESISTANCE FROM THE GUIDING CATHETER AND OUTSIDE THE ANATOMY THE HYPOTUBE SEPARATED. A NEW 3.0 X 18 MM XIENCE XPEDITION WAS USED SUCCESSFULLY TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2061941

    Patients

    Seq Age Sex Outcome Treatment
    1