BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3090840 · Received May 2, 2013

    Report

    Report Number
    2024168-2013-02738
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 25, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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. 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 AND THAT 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. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN THE HEAVILY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY, PRE-DILATATION WAS PERFORMED MULTIPLE TIMES USING A 2.0X15 TREK BALLOON AT 16 ATMOSPHERES. A 2.5X23 RX XIENCE V STENT DELIVERY SYSTEM (SDS) WAS ADVANCED THROUGH A 5.5F GUIDELINER. RESISTANCE WAS FELT WITH THE GUIDELINER WHILE ADVANCING THE SDS AROUND A BEND IN THE VESSEL. FORCE WAS APPLIED TO THE SDS AND THE STENT DISLODGED FROM THE SDS BALLOON WHILE STILL IN THE GUIDELINER. THE SDS, GUIDELINER, STANDARD 6F GUIDE CATHETER AND GUIDE WIRE WERE REMOVED AS A SINGLE UNIT WITH THE DISLODGED STENT REMAINING INSIDE THE GUIDELINER. A NEW SAME SDS WAS ADVANCED SUCCESSFULLY THROUGH A STANDARD 6F GUIDE CATHETER AND THE STENT WAS DEPLOYED AT THE TARGET LESION CONCLUDING THE PROCEDURE SUCCESSFULLY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191413 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2013141

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE CATHETER: 5.5 GUIDELINER, 6F GUIDE CATH