BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3033037 · Received April 3, 2013

    Report

    Report Number
    2024168-2013-01940
    Event Type
    Malfunction
    Date Received
    April 3, 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). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE COMPLAINT DEVICE WAS RETURNED. FAILURE TO ADVANCE/CROSS THE LESION AND DIFFICULTY TO REMOVE FROM THE ANATOMY COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON THE 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. A REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. IT WAS REPORTED THAT THE STENT DELIVERY SYSTEM (SDS) WAS WITHDRAWN AND RE-ADVANCED IN THE ANATOMY. IT SHOULD BE NOTED THAT THE XIENCE V EVEROLIMUS CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) STATES: 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. SHOULD ANY RESISTANCE BE FELT AT ANY TIME DURING WITHDRAWAL OF THE CORONARY STENT SYSTEM, THE ENTIRE SYSTEM SHOULD BE REMOVED AS A SINGLE UNIT. IN THIS CASE, THE IFU DEVIATION OF RE-ADVANCING THE SDS IN THE ANATOMY LIKELY DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED COMPLAINT. THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE DISTAL CIRCUMFLEX WITH HEAVY TORTUOSITY AND HEAVY CALCIFICATION. THE 2.5 X 23 MM XIENCE V STENT DELIVERY SYSTEM (SDS) WAS ADVANCED, BUT COULD NOT CROSS TO THE LESION DUE TO THE ANATOMY. THE SDS WAS REMOVED AND FURTHER DILATATION WAS PERFORMED. THE XIENCE V SDS WAS RE-INSERTED AND MULTIPLE ATTEMPTS WERE MADE, BUT THE SDS COULD NOT CROSS TO THE LESION DUE TO THE ANATOMY. THERE WAS NO FORCE APPLIED DURING THE ATTEMPTS TO CROSS THE LESION. DURING REMOVAL, RESISTANCE WAS NOTED WITH THE VESSEL. A NEW 2.25 X 23 MM XIENCE V SDS WAS USED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136774 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2060641

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR