BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2855141 · Received December 3, 2012

    Report

    Report Number
    2024168-2012-07649
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 8, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RETURNED FOR INVESTIGATION. THE INVESTIGATION IS NOT COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: IT SHOULD BE NOTED THAT THE XIENCE V INSTRUCTIONS FOR USE (IFU) 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. THE DISLODGED STENT IMPLANT WAS RETURNED FOR EVALUATION, THUS CONFIRMING THE REPORTED DISLODGEMENT. DIFFICULT TO POSITION/GUIDING CATHETER RESISTANCE COULD NOT BE TESTED AS THE ONLY THE DISLODGED STENT IMPLANT WAS RETURNED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INTERVENTIONAL STENTING PROCEDURE, A XIENCE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED THROUGH A NON-ABBOTT GUIDING CATHETER AND PRIOR TO ENTERING THE PATIENTS ANATOMY, AS THE XIENCE SDS WAS ADVANCING THROUGH THE NON- ABBOTT GUIDING CATHETER, INTO THE NON-ABBOTT GUIDELINER, THERE WAS RESISTANCE FELT. THE PHYSICIAN PUSHED FORWARD AGAINST THE RESISTANCE AND THE STENT DISLODGED. REPORTEDLY, THE STENT WAS FOUND STILL ATTACHED TO THE XIENCE SDS, BUT MORE PROXIMALLY ON THE SHAFT OF THE XIENCE SDS. THE XIENCE SDS WAS REMOVED WITHOUT DIFFICULTY, LEAVING THE SAME NON-ABBOTT GUIDING CATHETER, NON-ABBOTT GUIDELINER, AND NON-ABBOTT GUIDE WIRE INSIDE THE PATIENTS ANATOMY. ANOTHER NEW SAME SIZE XIENCE SDS WAS ADVANCED AND AGAIN THE XIENCE SDS MET RESISTANCE AS IT WAS ADVANCING THROUGH THE NON-ABBOTT GUIDING CATHETER, INTO THE NON-ABBOTT GUIDELINER, PRIOR TO ENTERING THE PATIENTS ANATOMY. THE PHYSICIAN PUSHED FORWARD AND AGAIN THE STENT DISLODGED AND WAS FOUND ATTACHED TO THE PROXIMAL SHAFT OF THE XIENCE SDS. THE XIENCE SDS WAS REMOVED WITHOUT DIFFICULTY AND THE NON-ABBOTT GUIDELINER WAS REMOVED FROM THE PATIENTS ANATOMY. ANOTHER NEW SAME SIZE XIENCE SDS WAS ADVANCED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA OR NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2041741

    Patients

    Seq Age Sex Outcome Treatment
    1