BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2091846 · Received May 17, 2011

    Report

    Report Number
    2024168-2011-03526
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    April 23, 2011
    Report Date
    April 25, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, 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. INSERTING DISTAL TO STENT. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ANALYSIS OF THE RETURNED PRODUCT NOTED THE STENT IMPLANT WAS STATIONARY ON THE TIGHTLY FOLDED BALLOON BETWEEN THE MARKERS WITH NO DAMAGE NOTED. THE DISTAL END OF THE SOFT TIP WAS FLARED. THERE WAS A KINK IN THE SOFT TIP 0.5 MM DISTAL TO THE CLEAR GAP. SINCE THIS DAMAGE WAS NOT REPORTED IN THE INCIDENT INFORMATION, THE TIP DAMAGE MAY HAVE OCCURRED DURING THE PROCEDURE OR DURING PACKAGING, HANDLING AND RETURN TO ABBOTT VASCULAR FOR ANALYSIS. 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 TIP LENGTH AND DISTAL AND MIDDLE STENT OUTER DIAMETERS WERE MEASURED AND MET MANUFACTURING CRITERIA. THE PROXIMAL STENT OUTER DIAMETERS COULD NOT BE MEASURED DUE TO THE DAMAGE NOTED. IT WAS REPORTED THE STENT DELIVERY SYSTEM WAS ATTEMPTING TO ADVANCE THROUGH A PREVIOUSLY PLACED STENT, WHICH MAY HAVE CONTRIBUTED TO THE REPORTED DIFFICULTIES. IT SHOULD BE NOTED THE XIENCE V INSTRUCTIONS FOR USE (IFU) STATES: ALTHOUGH THE SAFETY AND EFFECTIVENESS OF TREATING MORE THAN ONE VESSEL PER CORONARY ARTERY WITH XIENCE V STENTS HAS NOT BEEN ESTABLISHED, IF THIS IS PERFORMED, PLACE THE STENT IN THE DISTAL LESION BEFORE THE PROXIMAL LESION IN ORDER TO MINIMIZE DISLODGEMENT RISK INCURRED BY TRAVERSING THROUGH DEPLOYED STENTS. THE HYPOTUBE AND JACKET WERE SEPARATED 18 CM DISTAL TO THE STRAIN RELIEF TUBING, CONFIRMING THE REPORTED SEPARATION. THE HYPOTUBE FRACTURE FACE WAS OVAL SHAPED, AS IF KINKED PRIOR TO SEPARATION. THE HYPOTUBE JACKET WAS STRETCHED AT THE SEPARATION. THERE WAS A KINK IN THE HYPOTUBE 1.7 CM PROXIMAL TO THE SEPARATION. THERE WERE THREE BENDS IN THE HYPOTUBE 1.6 CM, 12 CM AND 30 CM DISTAL TO THE SEPARATION. KINKS OR BENDS IN THE SHAFT CAN LEAD TO WEAKENING OF THE CATHETER MATERIAL SUCH THAT SUBSEQUENT APPLICATION OF FORCE OR FURTHER HANDLING CAN CAUSE A SEPARATION. IN THIS CASE, THE PATIENT ANATOMY WAS MODERATELY TORTUOUS AND CALCIFIED WHICH LIKELY CONTRIBUTED TO THE REPORTED DIFFICULTIES. IT IS LIKELY THAT AS RESISTANCE WAS ENCOUNTERED; FORCE WAS APPLIED, RESULTING IN THE SHAFT KINKING. FURTHER MANIPULATION WOULD HAVE CONTRIBUTED TO THE SHAFT ULTIMATELY SEPARATING. IT SHOULD BE NOTED THE IFU STATES: APPLYING EXCESSIVE FORCE TO THE DELIVERY SYSTEM CAN POTENTIALLY RESULT IN LOSS OR DAMAGE TO THE STENT AND/OR DELIVERY SYSTEM COMPONENTS. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THE COMPLAINT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER REPORTED INCIDENTS OF HYPOTUBE SEPARATION FOR THIS LOT. THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE XIENCE V STENT WAS UNABLE TO CROSS THE TARGET LESION IN THE HEAVILY CALCIFIED PROXIMAL LEFT CIRCUMFLEX (LCX) ARTERY AS IT WAS GETTING HUNG UP ON A PREVIOUSLY IMPLANTED XIENCE V STENT IN THE MID TO DISTAL LCX. THE PHYSICIAN WAS APPLYING SIGNIFICANT PRESSURE ON THE SHAFT AND THE NOSE OF THE STENT AS HE WAS ATTEMPTING TO CROSS THE PRIOR STENT. DURING REMOVAL OF THE XIENCE V FROM THE PATIENT, THE SHAFT OF THE XIENCE V STENT DELIVERY SYSTEM (SDS) BROKE. A SECOND XIENCE V STENT OF THE SAME SIZE WAS IMPLANTED WITHOUT FURTHER INCIDENT. THE DETACHED SEGMENT OF THE XIENCE V SDS WAS FOUND IN THE GUIDING CATHETER. THERE WERE NO ADVERSE PATIENT EFFECTS. 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 1011241

    Patients

    Seq Age Sex Outcome Treatment
    1