BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3150848 · Received June 6, 2013

    Report

    Report Number
    2024168-2013-03556
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 15, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(4) - FAILURE TO FOLLOW STEPS/INSTRUCTIONS. THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED SHAFT SEPARATION WAS CONFIRMED. THE RESISTANCE DURING WITHDRAWAL COULD NOT BE TESTED DUE TO THE CONDITION OF THE DEVICE. BASED ON VISUAL 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. THE OTHER DEVICE (TREK) REFERENCED HAS BEEN FILED UNDER A SEPARATE MEDWATCH MFR NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TREK RX RUPTURED DURING PREDILATATION WITH LOW PRESSURES OF THE HEAVILY CALCIFIED, RIGHT CORONARY ARTERY (RCA) TARGET LESION. AN NC TREK WAS ABLE TO SUCCESSFULLY PREDILATE THE TARGET LESION. THE XIENCE XPEDITION (XX) STENT DELIVERY SYSTEM (SDS) CROSSED THE LESION SMOOTHLY AND THE STENT WAS DEPLOYED WITH ONE INFLATION. A COUPLE OF SECONDS WERE SPENT FOR THE SDS TO DEFLATE. NEUTRAL PRESSURE WAS APPLIED TO THE SDS AND THE SDS WAS PULLED INTO THE GUIDE CATHETER. SLIGHT RESISTANCE WAS ENCOUNTERED DURING REMOVAL OF THE SDS, A MINIMAL LEVEL OF FORCE WAS APPLIED, AND THE SHAFT SEPARATED IN THE GUIDE CATHETER. THE SEPARATED SEGMENT OF THE SDS WAS REMOVED WITH THE GUIDE CATHETER. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251027 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2112241

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE CATHETER: 6 FRENCH