BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3790727 · Received May 5, 2014

    Report

    Report Number
    2024168-2014-02815
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 10, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE STENT DELIVERY SYSTEM (SDS) WAS RETURNED FOR ANALYSIS. SHAFT SEPARATION WAS CONFIRMED. FAILURE TO ADVANCE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT IS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON A VISUAL/DIMENSIONAL ANALYSIS INSPECTION 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 QUERY/REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED. IT SHOULD BE NOTED THAT THE XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEMS 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. ADDITIONALLY, APPLYING EXCESSIVE FORCE TO THE DELIVERY SYSTEM CAN POTENTIALLY RESULT IN LOSS OR DAMAGE TO THE STENT AND / OR DELIVERY SYSTEM COMPONENTS. IN THIS INSTANCE, THE IFU DEVIATION APPEARS TO HAVE CONTRIBUTED TO THE REPORTED SHAFT SEPARATION.

    Additional Manufacturer Narrative · 1

    (B)(4) - RE-INSERTION, EXCESSIVE FORCE. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TARGET LESION WAS HIGHLY CALCIFIED AND LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). MULTIPLE PRE-DILATATIONS WERE PERFORMED WITH UNSPECIFIED COMPLIANT AND NON-COMPLIANT BALLOON CATHETERS. THE XIENCE PRIME 3.5 X 15 MM DEVICE WAS ADVANCED, BUT COULD NOT CROSS THE LESION. DURING THE ATTEMPTS TO CROSS THE LESION, THERE WERE MULTIPLE WITHDRAWALS OF THE XIENCE PRIME DEVICE FOR ADDITIONAL PRE-DILATATION. AFTER A RE-INSERTION OF THE XIENCE PRIME DEVICE, ADDITIONAL FORCE WAS USED TO TRY TO CROSS THE LESION. HOWEVER, THE SHAFT OF THE XIENCE PRIME SEPARATED AND WAS WITHDRAWN INSIDE THE GUIDE CATHETER. A NON-ABBOTT 3.0 X 15 MM STENT CROSSED THE LESION AND WAS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY OF PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266608 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 3021541

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: BALANCE MIDDLEWEIGHT