BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2171651 · Received July 21, 2011

    Report

    Report Number
    2024168-2011-05066
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 24, 2011
    Report Date
    June 24, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. EVALUATION SUMMARY: EVALUATION OF THE RETURNED XIENCE V STENT DELIVERY SYSTEM (SDS) FOUND BLOOD VISIBLE IN THE GUIDE WIRE LUMEN AND ON THE BALLOON AND CONTRAST IN THE INFLATION LUMEN, CONSISTENT WITH PREPARATION AND USE OF THE SDS IN THE PATIENT ANATOMY. THE BALLOON WAS LOOSELY FOLDED. THE SDS WAS RETURNED FROZEN ON THE ABBOTT GUIDE WIRE, CONFIRMING THE REPORTED INFORMATION. THERE WAS 182 CM OF THE GUIDE WIRE EXTENDING OUT FROM THE SDS TIP. THE INNER MEMBER WAS BUNCHED PROXIMAL TO THE PROXIMAL MARKER FOR A LENGTH OF 2.5 MM. THE DISTAL SHAFT WAS BUNCHED 1.8 CM PROXIMAL TO THE PROXIMAL SEAL FOR A LENGTH OF 1.4 CM. THE DISTAL END OF THE SOFT TIP WAS TORN. THERE WAS A KINK IN THE HYPOTUBE 20.7 CM PROXIMAL TO THE GUIDE WIRE EXIT NOTCH. THERE WAS A KINK IN THE GUIDE WIRE TIP 1.7 CM PROXIMAL TO THE TIPBALL. THERE WAS A KINK IN THE CORE 172 CM PROXIMAL TO THE PROXIMAL SOLDER. FACTORS THAT MAY CONTRIBUTE TO THE INABILITY TO RETRACT THE SDS OVER THE GUIDE WIRE AND CAUSE RESISTANCE BETWEEN THE DEVICES MAY INCLUDE, BUT NOT LIMITED TO, DEVICE PLACEMENT TECHNIQUE, GUIDING CATHETER SUPPORT, INNER DIAMETER OF GUIDE WIRE LUMEN, OUTER DIAMETER OF THE GUIDE WIRE, CONDITION OF THE GUIDE WIRE, BUILD UP OF BLOOD OR CONTRAST, OR DAMAGE TO THE CATHETER. TO ENSURE THIS IS NOT THE RESULT OF PRODUCT DEFICIENCY, ALL PRODUCTS ARE 100% VISUALLY INSPECTED FOR PROPER GUIDE WIRE MOVEMENT ON THE MANUFACTURING LINE. ADDITIONALLY, DURING LOT RELEASE TESTING, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO ENSURE PROPER GUIDE WIRE REVERSIBILITY. THE OUTER DIAMETERS OF THE GUIDE WIRE WERE MEASURED AND MET MANUFACTURING CRITERIA. THE INNER DIAMETER OF THE GUIDE WIRE EXIT NOTCH, TIP, AND INNER MEMBER UP TO THE BUNCHED SHAFT WERE MEASURED AND MET MANUFACTURING CRITERIA. THE REPORTED DIFFICULTIES WERE CONFIRMED AS AN ATTEMPT WAS MADE TO REMOVE THE GUIDE WIRE FROM THE SDS BUT THE GUIDE WIRE WAS NOT ABLE TO BE REMOVED. AFTER THE GUIDE WIRE AND SDS WERE SOAKED IN THE WATER BATH TO DISSOLVE THE BLOOD IN THE GUIDE WIRE LUMEN, THE GUIDE WIRE WAS REMOVED WITH RESISTANCE NOTED. THE RETURNED GUIDE WIRE WAS BACKLOADED THROUGH THE SDS WITH RESISTANCE AT THE BUNCHED INNER MEMBER AND BUNCHED DISTAL SHAFT. IT IS POSSIBLE THAT THE COAGULATION OF BLOOD ON THE GUIDE WIRE AND IN THE GUIDE WIRE LUMEN OF THE SDS CONTRIBUTED TO THE REPORTED DIFFICULTIES AS THERE WAS NO DAMAGE NOTED TO THE SDS PRIOR TO USE AND THERE WAS NO RESISTANCE REPORTED DURING ADVANCEMENT OF THE GUIDE WIRE, WHICH SUGGESTS A PRODUCT DEFICIENCY DID NOT CONTRIBUTE TO THE REPORTED DIFFICULTIES. AS RESISTANCE WAS ENCOUNTERED, IF FORCE WAS APPLIED, THIS WOULD CONTRIBUTE TO THE NOTED INNER MEMBER AND SHAFT BUNCHING. ADDITIONAL HANDLING DURING PACKING FOR RETURN ANALYSIS LIKELY CONTRIBUTED TO THE NOTED SHAFT KINK AND TEAR IN THE TIP. IT WAS REPORTED THE XIENCE V WAS USED IN THE TIBIAL ARTERY. IT SHOULD BE NOTED THE INSTRUCTIONS FOR USE STATES: THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (XIENCE V STENT) IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO NATIVE CORONARY ARTERY LESIONS. IT DOES NOT APPEAR THAT THE OFF LABEL USE OF THE XIENCE V SDS CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTIES. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO SIMILAR INCIDENTS REPORTED FOR DIFFICULT TO REMOVE THE GUIDE WIRE OR SHAFT DAMAGE FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE XIENCE V STENT WAS SUCCESSFULLY IMPLANTED IN THE TIBIAL LESION THAT DID NOT HAVE TORTUOSITY OR CALCIFICATION, IN WHICH THE PHYSICIAN KNEW WAS BEING USED OFF LABEL. THE GUIDE WIRE USED DURING THE CASE WAS A SPORT GUIDE WIRE. UPON REMOVAL OF THE XIENCE V STENT DELIVERY SYSTEM OVER THE GUIDE WIRE, BOTH WERE STUCK TOGETHER AND THEREFORE, WERE REMOVED AS A SYSTEM. OUTSIDE OF THE PATIENT'S ANATOMY, THE CATH LAB TECHNICIAN WAS TRYING TO PULL THEM APART, BUT THIS WAS NOT SUCCESSFUL. AS THE CASE WAS OVER, THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA AND THE PATIENT WAS REPORTED AS FINE. NO ADDITIONAL INFORMATION WAS 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 1032941

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR S'PORT EXCHANGE GUIDE WIRE