BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3233068 · Received July 18, 2013

    Report

    Report Number
    2024168-2013-04505
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 24, 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. SHAFT KINK WAS CONFIRMED AND SHAFT SEPARATION WAS NOTED. 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 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. ADDITIONALLY, THE 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. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4) - RE-INSERTION; EXCESSIVE FORCE. 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 THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED RIGHT CORONARY ARTERY. A 3.0 X 28 MM XIENCE V WAS ADVANCE BUT COULD NOT CROSS THE LESION. THE CATHETER WAS REMOVED AND ADDITIONAL DILATATION WAS PERFORMED WITH AN UNKNOWN 2.5 X 20 MM BALLOON CATHETER. THE XIENCE V WAS RE-INSERTED AND SEVERAL ATTEMPTS WERE MADE TO CROSS THE LESION; HOWEVER THE CATHETER COULD NOT CROSS. FORCE WAS APPLIED AND THE DISTAL SHAFT KINKED. THE CATHETER WAS REMOVED AND A NEW 2.75 X 28 MM XIENCE V WAS USED TO COMPLETE THE PROCEDURE. THERE WAS RESISTANCE FELT DURING ADVANCEMENT AND REMOVAL DUE TO THE ANATOMY. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334806 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2052541

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR GUIDE WIRE: BALANCE MIDDELWEIGHT UNIVERSAL II