BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE PRO EVEROLIMUS ELUTING RX CORONARY STENT SYSTEM

    MDR report key: 3193456 · Received June 27, 2013

    Report

    Report Number
    2024168-2013-04029
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    May 31, 2013
    Report Date
    June 3, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EXCESSIVE FORCE. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE SHAFT SEPARATION WAS CONFIRMED. 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. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. IT SHOULD BE NOTED THAT THE XIENCE PRO EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU)STATES: APPLYING EXCESSIVE FORCE TO THE DELIVERY SYSTEM CAN POTENTIALLY RESULT IN LOSS OR DAMAGE TO THE STENT AND / OR DELIVERY SYSTEM COMPONENTS. IN THIS CASE, THE IFU DEVIATION LIKELY CONTRIBUTED TO THE REPORTED SHAFT SEPARATION.

    Additional Manufacturer Narrative · 1

    (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 RELEVANT INFORMATION. THE ADDITIONAL XIENCE PRO DEVICES REFERENCED ARE BEING FILED UNDER SEPARATE MEDWATCH REPORTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE HEAVILY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. THE TREATMENT PLAN WAS TO PLACE SEVERAL STENTS IN THE VESSEL USING A KISSING STENT TECHNIQUE. PREDILATATION WAS PERFORMED WITH TWO NON-ABBOTT BALLOONS. DUE TO THE HEAVY CALCIFICATION, STRONG RESISTANCE WAS FELT FROM THE BEGINNING DURING ADVANCEMENT AND FORCE WAS APPLIED DURING THE ATTEMPTS TO CROSS. FOR THE FIRST TWO DEVICES, A 2.5X23 MM AND 2.5X28 MM XIENCE PRO, THE SHAFTS SEPARATED PROXIMALLY DURING ADVANCEMENT; HOWEVER, WITH SOME RESISTANCE FELT COULD BE EASILY REMOVED FROM THE ANATOMY. THE THIRD DEVICE ALSO BECAME STUCK DURING ADVANCEMENT, BUT IN THIS CASE THE SHAFT ONLY KINKED AND WAS ALSO ABLE TO BE REMOVED; HOWEVER WITH SOME RESISTANCE FELT DURING RETRACTION. THE PROCEDURE CONTINUED WITH ADDITIONAL XIENCE PRO STENTS, WHICH WERE ABLE TO BE PLACED SUCCESSFULLY. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291977 XIENCE PRO EVEROLIMUS ELUTING RX CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2103041

    Patients

    Seq Age Sex Outcome Treatment
    1