BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3935880 · Received July 15, 2014

    Report

    Report Number
    2024168-2014-04529
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 12, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED KINK AND SHAFT SEPARATION WERE CONFIRMED. DIFFICULT TO POSITION/GUIDING CATHETER RESISTANCE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT DUE TO THE CONDITION OF THE RETURNED DEVICE. 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. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A NARROW DISTAL RIGHT CORONARY ARTERY. A 2.75 X 23 MM XIENCE XPEDITION STENT DELIVERY SYSTEM (SDS) WAS BEING ADVANCED THROUGH A 6F GUIDING CATHETER WHEN THERE WAS RESISTANCE AND THE PROXIMAL SHAFT OF THE SDS KINKED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A 2.75 X 28 MM XIENCE XPEDITION. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURNED DEVICE ANALYSIS REVEALED THE PROXIMAL SHAFT WAS SEPARATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413638 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 4011441

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE CATH: MDT JR 4.0 6F/JL4.0 6F