BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1953242 · Received January 7, 2011

    Report

    Report Number
    2024168-2011-00149
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 14, 2010
    Report Date
    December 15, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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. DILATATION CATHETER: 2.0 X 6 SPRINTER; GUIDE WIRE: 300 CM IRON MAN, EXTRA SUPPORT. EVALUATION SUMMARY: EVALUATION OF THE RETURNED XIENCE V STENT DELIVERY SYSTEM (SDS) NOTED BLOOD VISIBLE IN THE GUIDE WIRE LUMEN AND INFLATION LUMEN, WHICH IS CONSISTENT WITH A SEPARATION. THERE WAS CONTRAST IN THE BALLOON, WHICH IS CONSISTENT WITH PREPARATION. THE STENT IMPLANT WAS DISLODGED FROM THE BALLOON AND WAS NOT RETURNED. THERE WERE CRIMP MARKS ON THE BALLOON BUT NOT BETWEEN THE MARKERS, DUE TO THE INNER MEMBER BUNCHING. THE DISTAL END OF THE BALLOON HAD RELAXED FOLDS AND THE MIDDLE PORTION AND PROXIMAL END OF THE BALLOON WERE TIGHTLY FOLDED. THE INNER MEMBER WAS SEPARATED 1 CM DISTAL TO THE GUIDE EXIT NOTCH. THE BALLOON WAS SEPARATED AT THE PROXIMAL SEAL. BOTH MATERIALS AT THE SEPARATION WERE JAGGED. THE SEPARATED INNER MEMBER INCLUDING THE BALLOON WAS RETURNED FROZEN ON A RETURNED IRON MAN GUIDE WIRE. THE INNER MEMBER WAS BUNCHED 2 MM DISTAL FROM THE DISTAL BALLOON MARKER AND EXTENDING PROXIMALLY FROM THE PROXIMAL BALLOON MARKER, FOR AN OVERALL LENGTH OF 1.3 CM. THE INNER MEMBER BUNCHING CAUSED THE MARKERS TO BE 5 MM BETWEEN EACH OTHER. THERE WAS 251.5 CM OF THE RETURNED IRON MAN GUIDE WIRE PROTRUDING OUT FROM THE TIP OF THE RETURNED SDS. THE RETURNED IRON MAN GUIDE WIRE WAS RETURNED WITH BLOOD AND CONTRAST ON THE COILS AND CORE. THERE WERE TWO BENDS IN THE CORE 5 MM AND 1.8 CM PROXIMAL TO THE TIPBALL. THE INABILITY TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, AND ACCESSORY DEVICE SUPPORT. THE ENTIRE LENGTH OF THE TIP WAS MEASURED AND MET MANUFACTURING CRITERIA. THE PATIENT ANATOMY WAS HEAVILY TORTUOUS AND CALCIFIED WHICH LIKELY CONTRIBUTED TO THE FAILURE TO ADVANCE. FACTORS THAT MAY CONTRIBUTE TO THE INABILITY TO ADVANCE/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. PIN GAUGES WERE USED TO MEASURE THE GUIDE WIRE EXIT NOTCH AND THE INNER DIAMETER MET MANUFACTURING CRITERIA. A LASER MICROMETER WAS USED TO MEASURE THE OUTER DIAMETER OF THE RETURNED IRON MAN GUIDE WIRE AND THE OUTER DIAMETER MET MANUFACTURING CRITERIA. IT IS POSSIBLE THAT THE BUILD UP OF BLOOD IN THE GUIDE WIRE LUMEN OF THE SDS AND ON THE GUIDE WIRE CONTRIBUTED TO THE DIFFICULTIES ADVANCING THE SDS. ADDITIONALLY, AS RESISTANCE WAS ENCOUNTERED, IF FORCE WAS APPLIED, THIS WOULD CONTRIBUTE TO THE SHAFT BUNCHING, CREATING ADDITIONAL RESISTANCE. THE ATTEMPTS TO REMOVE THE FROZEN SDS FROM THE GUIDE WIRE WOULD THEN CONTRIBUTE TO THE SHAFT SEPARATING AND FURTHER DAMAGE TO THE SDS. ADDITIONAL HANDLING MAY HAVE CONTRIBUTED TO THE STENT DISLODGING FROM THE BALLOON, AS THE DAMAGE WAS NOT REPORTED IN THE INCIDENT INFORMATION. THE STENT MAY ALSO HAVE DISLODGED DURING THE PROCEDURE OR DURING PACKAGING, HANDLING AND RETURN TO ABBOTT VASCULAR FOR ANALYSIS. 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. A CONCLUSIVE CAUSE FOR THE DIFFICULTY ADVANCING/REMOVING THE SDS ON THE GUIDE WIRE COULD NOT BE DETERMINED; HOWEVER, THE FAILURE TO ADVANCE AND SHAFT SEPARATION APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THE PROFILE DIMENSIONS ON ALL STENT DELIVERY SYSTEMS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ON THE MANUFACTURING LINE BEFORE RELEASE. ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED AND CHECKED FOR PROPER GUIDE WIRE MOVEMENT ON THE MANUFACTURING LINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE XIENCE V WAS UNABLE TO CROSS THE HEAVILY TORTUOUS AND CALCIFIED DISTAL RIGHT CORONARY ARTERY (RCA) AND WAS REMOVED FROM THE PATIENT. DURING ADVANCEMENT OF THE NON-ABBOTT BALLOON AND OF THE XIENCE V STENT, THE TORTUOSITY OF THE VESSEL CAUSED THE GUIDE WIRE TO PARTIALLY COME OUT OF THE PATIENT. A SECOND GUIDE WIRE WAS INSERTED FOR ADDED SUPPORT OR TO BUDDY WIRE THE LESION. THE XIENCE V WAS THEN LOADED ON TO THE IRON MAN GUIDE WIRE, BUT WAS UNABLE TO BE ADVANCED AND BECAME STUCK ON THE WIRE OUTSIDE OF THE PATIENT. ALTHOUGH THE IRON MAN GUIDE WIRE WAS WIPED DOWN WITH HEPARINIZED SALINE, THE XIENCE V WOULD NOT BUDGE FROM THE GUIDE WIRE AND BECAME DETACHED ON THE PROXIMAL PORTION OF THE SHAFT FROM THE ATTEMPTS TO REMOVE IT. THE IRON MAN GUIDE WIRE AND THE XIENCE V WERE REMOVED FROM THE PATIENT AS A SINGLE UNIT. A PROMUS STENT WAS ABLE TO CROSS TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS 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 9121741

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR