BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3160005 · Received June 10, 2013

    Report

    Report Number
    2024168-2013-03631
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Date of Event
    April 15, 2013
    Report Date
    May 17, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED DIFFICULT TO POSITION/DIFFICULT TO REMOVE (GUIDE WIRE RESISTANCE) WERE 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. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: GUIDE WIRE: BALANCE MIDDLE-WEIGHT (BMW) ELITE; GUIDE CATHETER: 6 FRENCH CORDIS XB 3.5. THE DEVICE WAS RECEIVED. THE INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE BALANCE MIDDLE-WEIGHT ELITE GUIDE WIRE REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE XIENCE XPEDITION STENT DELIVERY SYSTEM (SDS) REACHED THE PREDILATED, VERY TORTUOUS, MILDLY CALCIFIED TARGET LESION IN THE DISTAL LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD). THE PHYSICIAN NOTICED THAT THE BALANCE MIDDLE-WEIGHT (BMW) ELITE GUIDEWIRE MOVED WITH THE SDS, BUT WAS ABLE TO DEPLOY THE STENT WITHOUT ISSUE. THE STENT APPEARED WELL APPOSED TO THE VESSEL. THE SDS WAS DEFLATED, BUT THE SDS COULD NOT BE REMOVED FROM THE GUIDEWIRE; THEREFORE, BOTH DEVICES WERE REMOVED TOGETHER AS A SINGLE UNIT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO REPORTED ADVERSE PATIENT EFFECTS. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260135 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2091341

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR