BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 4102080 · Received September 19, 2014

    Report

    Report Number
    2024168-2014-06045
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 27, 2014
    Report Date
    August 27, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE SEPARATION WAS ABLE TO BE CONFIRMED. BASED ON A VISUAL 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 ELECTRONIC COMPLAINT DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FOR SEPARATIONS FROM THIS LOT. IT SHOULD BE NOTED THE XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) STATES: ATTACH AN INFLATION DEVICE/SYRINGE TO THE STOPCOCK; ATTACH IT TO THE INFLATION PORT OF THE PRODUCT. DO NOT BEND THE PRODUCT HYPOTUBE, WHEN CONNECTING TO THE INFLATION DEVICE/SYRINGE. WITH THE TIP DOWN, ORIENT THE DELIVERY SYSTEM VERTICALLY. OPEN THE STOPCOCK TO DELIVERY SYSTEM; PULL NEGATIVE FOR 30 SECONDS; RELEASE TO NEUTRAL FOR CONTRAST FILL. CLOSE THE STOPCOCK TO THE DELIVERY SYSTEM; PURGE THE INFLATION DEVICE/SYRINGE OF ALL AIR. REPEAT STEPS UNTIL ALL AIR IS EXPELLED. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED

    Additional Manufacturer Narrative · 1

    (B)(4) - INCORRECT PREP. 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 DURING A PROCEDURE OF THE UNSPECIFIED VESSEL THE 2.75 X 12 MM XIENCE XPEDITION STENT DELIVERY SYSTEM (SDS) WAS ACROSS THE LESION WHEN THE PHYSICIAN ATTEMPTED TO PREP THE DEVICE IN THE ANATOMY USING A (B)(4) TECHNIQUE AND WHILE ATTACHING THE SYRINGE THE PROXIMAL SHAFT DETACHED. THE DEVICE WAS REMOVED FROM THE ANATOMY WITHOUT ISSUE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582564 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 4060941

    Patients

    Seq Age Sex Outcome Treatment
    1