BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3140913 · Received June 3, 2013

    Report

    Report Number
    2024168-2013-03429
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 8, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE WHISPER GUIDE WIRE REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED BALLOON/SHAFT SEPARATION AND DIFFICULT TO POSITION/DIFFICULT TO REMOVE (GUIDE WIRE RESISTANCE) WERE 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 V / XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE STATES: SHOULD ANY RESISTANCE BE FELT AT ANY TIME DURING EITHER LESION ACCESS OR REMOVING THE DELIVERY SYSTEM POST-STENT IMPLANTATION, THE STENT DELIVERY SYSTEM AND THE GUIDING 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 AND/OR VASCULATURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN A 3.0 X 23 MM XIENCE V STENT DELIVERY SYSTEM (SDS) WAS BEING ADVANCED OVER A WHISPER GUIDE WIRE, THE CATHETER STUCK ON THE GUIDE WIRE AND WHEN ATTEMPTING TO CONTINUE TO ADVANCE THE SDS, THE BALLOON SEPARATED FROM THE OUTER MEMBER BEFORE THE SDS ENTERED THE ANATOMY. THE INNER MEMBER REMAINED INTACT. THE SDS AND THE GUIDE WIRE WERE REMOVED AS A SINGLE UNIT AND A NEW XIENCE V AND WHISPER GUIDE WIRE WERE SUCCESSFULLY USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244027 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2060841

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: 014 WHISPER