BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1890789 · Received November 1, 2010

    Report

    Report Number
    2024168-2010-02310
    Event Type
    Malfunction
    Date Received
    November 1, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 7, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY: THE INABILITY TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PT ANATOMICAL MORPHOLOGY, PT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, DEVICE SIZE SELECTION AND ACCESSORY DEVICE SUPPORT; AND IS TYPICALLY NOT ASSOCIATED WITH A PRODUCT QUALITY DEFICIENCY. IN THIS CASE, IT APPEARS THE DIFFICULTIES ADVANCING MAY BE RELATED TO THE PT'S ANATOMICAL CONDITIONS, AS IT WAS REPORTED THAT ANOTHER XIENCE V UNIT ALSO FAILED TO CROSS. THE REPORTED SHAFT SEPARATION WAS CONFIRMED. THE HYPOTUBE AND JACKET WERE SEPARATED 11 CM DISTAL TO THE STRAIN RELIEF TUBING. THE FRACTURE FACES WERE OVALED, SUGGESTING THAT THE SHAFT HAD KINKED PRIOR TO SEPARATING. THE JACKET MATERIAL WAS STRETCHED AND JAGGED AT THE SEPARATION, SUGGESTING A DUCTILE OVERLOAD. ADDITIONALLY, THERE WERE FOUR KINKS IN THE HYPOTUBE, 2 AND 4.5 CM PROXIMAL TO THE SEPARATION AND 15 AND 16 CM DISTAL TO THE SEPARATION. THERE WAS NO OTHER DAMAGE NOTED TO THE STENT DELIVERY SYSTEM (SDS). IN THIS CASE, IT APPEARS THAT THE SHAFT LIKELY KINKED AND SEPARATED AS A RESULT OF PUSHING AGAINST RESISTANCE WHILE ATTEMPTING TO CROSS THE LESION. IF THE PROXIMAL END OF THE SDS IS NOT PROPERLY SUPPORTED DURING PUSHING OR ADVANCING AGAINST RESISTANCE, IT MAY CAUSE THE SHAFT TO KINK. ONCE THE SHAFT IS KINKED, AND UPON STRAIGHTENING, THE HYPOTUBE MATERIAL COULD SEPARATE. THE ADD'L KINKS NOTED MAY BE THE RESULT OF PUSHING AGAINST RESISTANCE AS THERE WERE NO KINKS NOTED DURING THE USE INSPECTION. THE ADD'L KINKS MAY ALSO BE THE RESULT OF PREPARING/PACKAGING THE PRODUCT FOR RETURN TO ABBOTT VASCULAR. THE REPORTED FAILURE TO CROSS, KINKS, AND SHAFT SEPARATION AND APPEAR TO BE RELATED TO CASE CIRCUMSTANCES, AND THERE IS NO INDICATION TO SUGGEST A PRODUCT QUALITY DEFICIENCY. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT. ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED FOR KINKS DURING THE MFG PROCESS. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY LUMEN INTEGRITY. THE PROFILE DIMENSIONS ON ALL STENT DELIVERY SYSTEMS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ON THE MFG LINE BEFORE RELEASE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN THE RIGHT CORONARY ARTERY, THE XIENCE V STENT SYSTEM WAS ADVANCED, BUT COULD NOT CROSS THE LESION. THE DEVICE WAS REMOVED AND A SECOND XIENCE V STENT SYSTEM WAS ADVANCED, BUT COULD NOT CROSS. DURING THE ATTEMPT TO ADVANCE THE DEVICE, THE PROXIMAL SHAFT SEPARATED OUTSIDE OF THE PT'S ANATOMY. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING A SHORTER (SIZE UNK) XIENCE V STENT SYSTEM. THERE WAS NO ADVERSE PT EFFECT. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA 0072141

    Patients

    Seq Age Sex Outcome Treatment
    1 XIENCE V STENT SYSTEM