BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1953179 · Received January 7, 2011

    Report

    Report Number
    2024168-2011-00127
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 11, 2010
    Report Date
    December 14, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: INVESTIGATION OF THE RETURNED DEVICE FOUND BLOOD IN THE GUIDE WIRE LUMEN AND ON THE BALLOON, BUT NO VISIBLE CONTRAST. THE STENT IMPLANT WAS STATIONARY BETWEEN THE MARKERS ON THE TIGHTLY FOLDED BALLOON. THIS IS ALL CONSISTENT WITH THE REPORTED EVENT THAT THE PRODUCT WAS INSERTED IN THE BODY, AT LEAST PARTIALLY ADVANCED OVER A GUIDE WIRE, BUT THE BALLOON WAS NOT INFLATED. 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, PRODUCT PLACEMENT TECHNIQUE, PRODUCT SIZE SELECTION AND ACCESSORY DEVICE SUPPORT; AND IS TYPICALLY NOT ASSOCIATED WITH A PRODUCT QUALITY DEFICIENCY. ANALYSIS NOTED THAT THE STENT OUTER DIAMETER MEASUREMENTS AND TIP LENGTH MET MANUFACTURING CRITERIA AND NO KINKS OR DAMAGE WAS NOTED TO THE TIP. THERE WAS NO DAMAGE NOTED TO THE STENT IMPLANT. BASED ON THE REPORTED INFORMATION, THE INABILITY TO CROSS APPEARS TO BE RELATED TO THE HIGHLY CALCIFIED, MODERATELY TORTUOUS LESION AND/OR PRODUCT SIZE SELECTION, AS THE 3.0 X 28MM RX XIENCE V STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS, BUT SHORTER TREK DILATATION CATHETERS WERE ABLE TO CROSS. IT WAS ALSO NOTED THAT THE HYPOTUBE AND JACKET MATERIAL WERE SEPARATED DISTAL TO THE STRAIN RELIEF TUBING, CONFIRMING THE REPORTED SHAFT DETACHMENT. THE FRACTURE FACES WERE OVALED, AS IF KINKED PRIOR TO SEPARATION. THE JACKET MATERIAL AT THE SEPARATION WAS STRETCHED AND JAGGED, WHICH SUGGESTS TENSILE OVERLOAD (MATERIAL STRESS/FATIGUE). SHAFT SEPARATIONS ARE OFTEN ATTRIBUTED TO DUCTILE OVERLOAD AT A KINK. ANALYSIS NOTED TWO KINKS IN THE SHAFT, LOCATED DISTAL TO THE GUIDE WIRE EXIT NOTCH, AND A KINK IN THE HYPOTUBE, LOCATED DISTAL TO THE STRAIN RELIEF TUBING. THE KINKS LIKELY OCCURRED AS A RESULT OF THE PROCEDURAL ATTEMPT TO CROSS THE LESION OR FROM HANDLING OF THE PRODUCT DURING PACKING/SHIPPING BACK TO ABBOTT VASCULAR, AS THIS DAMAGE WAS NOT REPORTED DURING THE INSPECTION PRIOR TO USE. KINKS IN THE SHAFT CAN LEAD TO WEAKENING OF THE SDS MATERIAL SUCH THAT SUBSEQUENT APPLICATION OF FORCE OR FURTHER HANDLING CAN CAUSE A SEPARATION. SINCE IT WAS REPORTED THAT THE SDS WAS PUSHED AND PULLED AGAINST RESISTANCE DURING THE PROCEDURE, 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 REMOVAL OF THE DELIVERY SYSTEM POST-STENT IMPLANTATION, THE ENTIRE SYSTEM 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. IN THIS CASE, IT IS POSSIBLE THAT PUSHING AND PULLING THE SDS WHEN RESISTANCE WAS ENCOUNTERED WHILE ATTEMPTING TO CROSS THE MODERATELY TORTUOUS, HIGHLY CALCIFIED LESION CONTRIBUTED TO THE KINKS AND SHAFT SEPARATION. THE REPORTED DIFFICULTIES AND NOTED KINKS APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PRODUCT AND NOT A PRODUCT QUALITY DEFICIENCY. A REVIEW OF THE DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMITIES WHICH COULD HAVE CONTRIBUTED THE REPORTED EVENT. ALL STENT DELIVERY SYSTEMS ARE SUBJECTED TO A 100% VISUAL INSPECTION. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS USED TO VERIFY THE PRODUCT QUALITY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. DILATATION CATHETER: MINI TREK 2.0X 12 MM, TREK 3.0 X 12 MM. GUIDE WIRE: WHISPER ES. GUIDE CATHETER: EBU 3.5.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN THE HEAVILY CALCIFIED MID CIRCUMFLEX ARTERY, PRE-DILATATION WAS PERFORMED USING A MINI TREK BALLOON FOLLOWED BY ANOTHER TREK BALLOON. BOTH DILATATION CATHETERS ADVANCED EASILY AND DILATATION WAS PERFORMED SUCCESSFULLY. A XIENCE V 3.0 X 28 MM STENT SYSTEM WAS INSERTED INTO THE ANATOMY; HOWEVER, RESISTANCE WAS FELT. THE STENT SYSTEM WAS PUSHED AND PULLED TO POSITION THE DEVICE; HOWEVER, THE DELIVERY CATHETER SEPARATED INTO TWO PIECES DISTALLY. THERE WAS NO REPORTED INTERVENTION AND NO ADVERSE PATIENT EFFECT. THOUGH REQUESTED, 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 0031041

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR