BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE PRO EVEROLIMUS ELUTING RX CORONARY STENT SYSTEM

    MDR report key: 3884118 · Received June 19, 2014

    Report

    Report Number
    2024168-2014-03930
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 26, 2014
    Report Date
    May 26, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED HUB BREAK WAS CONFIRMED AS THE HYPOTUBE WAS SEPARATED. FAILURE TO ADVANCE 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 THIS COMPLAINT. A QUERY/REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. IT SHOULD BE NOTED THE XIENCE PRO EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE STATES THAT 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) - AGAINST RESISTANCE. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE XIENCE PRO IS CURRENTLY NOT COMMERCIALLY AVAILABLE IN THE US.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MDR REPORT, ADDITIONAL REPORTED INFORMATION INDICATES THAT THE HUB WAS NOT SEPARATED INTO TWO PIECES; HOWEVER, THE HUB WAS BARELY ATTACHED TO THE DELIVERY SYSTEM.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361165 XIENCE PRO EVEROLIMUS ELUTING RX CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 3101641

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: BALANCE MIDDLEWEIGHT