BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3103086 · Received May 9, 2013

    Report

    Report Number
    2024168-2013-02905
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 2, 2013
    Report Date
    April 16, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. DIFFICULTY/RESISTANCE REMOVING THE DEVICE POST-DEPLOYMENT COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. SHAFT SEPARATION WAS CONFIRMED. 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. 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. IT SHOULD BE NOTED THAT THE XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE STATES IF, DURING WITHDRAWAL OF THE CATHETER POST-DEPLOYMENT, RESISTANCE IS ENCOUNTERED, RE-INFLATE THE BALLOON UP TO NOMINAL PRESSURE, DEFLATE THE BALLOON BY PULLING NEGATIVE FOR 30 SECONDS, CONFIRM BALLOON DEFLATION, WAIT ANOTHER 10-15 SECONDS, THEN WITHDRAWAL UNDER NEGATIVE OR NEUTRAL PRESSURE. 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY. AFTER PREDILATATION WAS PERFORMED, THE XIENCE XPEDITION WAS DEPLOYED SUCCESSFULLY; HOWEVER, DURING RETRACTION OF THE DELIVERY SYSTEM FROM THE ANATOMY WITH SOME RESISTANCE FELT AND SOME FORCE APPLIED, IT WAS OBSERVED THAT THE PROXIMAL SHAFT WAS SEPARATED. POST DILATATION WAS PERFORMED AND THE PROCEDURE WAS CLOSED. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203655 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2070441

    Patients

    Seq Age Sex Outcome Treatment
    1