BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3120616 · Received May 20, 2013

    Report

    Report Number
    2024168-2013-03181
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 25, 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. FAILURE TO ADVANCE/CROSS THE LESION AND DIFFICULTY/RESISTANCE REMOVING THE DEVICE FROM THE ANATOMY COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS THEY WERE 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. REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. IT SHOULD BE NOTED THAT THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) INSTRUCTS THE PHYSICIAN TO: PRE-DILATE THE LESION WITH A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER. ADDITIONALLY, THE IFU STATES: 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. 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). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT USING A RADIAL ARTERY ACCESS APPROACH DURING A PROCEDURE OF THE HEAVILY CALCIFIED, LEFT MAIN (LM) ARTERY, DURING DIRECT STENTING THE 3.5 X 8 MM XIENCE V STENT DELIVERY SYSTEM (SDS) WAS ADVANCED BUT COULD NOT CROSS THE LESION. THE XIENCE V SDS WAS WITHDRAWN FROM THE PATIENT ANATOMY WITHOUT ISSUE AND PRE-DILATATION WAS PERFORMED WITH A 2.5 X12 MM UNSPECIFIED BALLOON DILATATION CATHETER (BDC). THE 3.5 X 8 MM XIENCE V SDS WAS RE-INSERTED AND ADVANCED AND SEVERAL UNSUCCESSFUL ATTEMPTS TO CROSS THE LESION WERE MADE. NO FORCE WAS APPLIED DURING THE UNSUCCESSFUL ATTEMPTS TO CROSS THE LESION. THE XIENCE V SDS MET RESISTANCE BUT WAS WITHDRAWN FROM THE PATIENT ANATOMY WITHOUT ISSUE. A NEW 3.0 X 8 MM XIENCE V SDS WAS ADVANCED AND IMPLANTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE PATIENT'S FINAL OUTCOME WAS SATISFACTORY. DURING ACCESS AND REMOVAL, THERE WAS RESISTANCE FELT; THE RESISTANCE WAS DUE TO THE VESSEL. 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
    222053 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2011741

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR GUIDE WIRE: BALANCE MIDDLEWEIGHT UNIVERSAL II