BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3031645 · Received April 2, 2013

    Report

    Report Number
    2024168-2013-01930
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 11, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE FAILURE TO ADVANCE/CROSS AND RESISTANCE DURING WITHDRAWAL COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON VISUAL AND DIMENSIONAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. IT SHOULD BE NOTED THAT THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) STATES: PRE-DILATE THE LESION WITH A PTCA CATHETER. THE IFU ALSO STATES THAT AN UNEXPANDED STENT MAY BE RETRACTED INTO THE GUIDING CATHETER ONE TIME ONLY. AN UNEXPANDED STENT SHOULD NOT BE REINTRODUCED INTO THE ARTERY ONCE IT HAS BEEN PULLED BACK INTO THE GUIDING CATHETER. SUBSEQUENT MOVEMENT IN AND OUT THROUGH THE DISTAL END OF THE GUIDING CATHETER SHOULD NOT BE PERFORMED AS THE STENT MAY BE DAMAGED WHEN RETRACTING THE UNDEPLOYED STENT BACK INTO THE GUIDING CATHETER. ADDITIONALLY, THE IFU STATES THAT 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. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. (B)(4) - NO PRE-DILATATION; RE-INSERTION; AGAINST RESISTANCE. THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE FOR TREATMENT OF A LESION IN THE HEAVILY CALCIFIED/TORTUOUS DISTAL LEFT CIRCUMFLEX ARTERY VIA RADIAL ACCESS, PRE-DILATATION WAS NOT PERFORMED AND A 3.5X18 RX XIENCE V STENT DELIVERY SYSTEM WAS ADVANCED BUT COULD NOT CROSS THE LESION. THE STENT DELIVERY SYSTEM WAS WITHDRAWN WITH RESISTANCE DUE TO THE ANATOMY, AND PRE-DILATATION WAS PERFORMED USING AN UNSPECIFIED 2.5X20 BALLOON CATHETER. THE RX XIENCE V STENT DELIVERY SYSTEM WAS RE-INSERTED AND SEVERAL UNSUCCESSFUL ATTEMPTS WERE MADE TO CROSS THE LESION. NO FORCE WAS APPLIED DURING THE UNSUCCESSFUL ATTEMPTS TO CROSS THE LESION AND THE SDS WAS WITHDRAWN FROM THE PATIENT ANATOMY WITH RESISTANCE DUE TO THE ANATOMY. A NEW 3.0X18 XIENCE V SDS WAS ADVANCED SUCCESSFULLY AND THE STENT WAS IMPLANTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO ADVERSE PATIENT EFFECT AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134045 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2070341

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR