BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 4100261 · Received September 18, 2014

    Report

    Report Number
    2024168-2014-06032
    Event Type
    Malfunction
    Date Received
    September 18, 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
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FAILURE TO FOLLOW STEPS/INSTRUCTIONS. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTION - DEVICE NOT RETURNING. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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 STENT DISLODGEMENTS FROM THIS LOT. IT SHOULD BE NOTED THE XIENCE XPEDITION, XIENCE XPEDITION SV, AND XIENCE XPEDITION LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM ELECTRONIC INSTRUCTIONS FOR USE (IFU) STATES: PRIOR TO USING THE XIENCE XPEDITION STENT SYSTEM, CAREFULLY REMOVE THE SYSTEM FROM THE PACKAGE AND INSPECT FOR BENDS, KINKS, AND OTHER DAMAGE. VERIFY THAT THE STENT DOES NOT EXTEND BEYOND THE RADIOPAQUE BALLOON MARKERS. DO NOT USE IF ANY DEFECTS ARE NOTED. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 3.5 X 28 MM XIENCE XPEDITION STENT DELIVERY SYSTEM WAS ADVANCED TO THE LESION; HOWEVER, WHEN THE PHYSICIAN WENT TO DEPLOY THE STENT IT WAS NOTED THAT THE STENT IMPLANT WAS NOT ON THE BALLOON. THE DEVICE WAS REMOVED WITHOUT INFLATING. THE STENT WAS FOUND ON THE STYLET. THERE WAS NO RESISTANCE NOTED WHEN REMOVING THE PROTECTIVE SHEATH OR STYLET. ANOTHER SAME SIZE XIENCE XPEDITION WAS SUCCESSFULLY USED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580449 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 305284A

    Patients

    Seq Age Sex Outcome Treatment
    1