BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3142673 · Received June 3, 2013

    Report

    Report Number
    2024168-2013-03446
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    April 24, 2013
    Report Date
    May 9, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ONLY THE STENT IMPLANT AND PROTECTIVE SHEATH WERE RETURNED FOR EVALUATION. THE REPORTED STENT DISLODGEMENT WAS CONFIRMED. THE DELIVERY SYSTEM CATHETER WAS NOT RETURNED. WHILE REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT, BASED ON AN EXPANDED INVESTIGATION, A PRODUCT ISSUE RELATED TO STENT DISLODGEMENTS OCCURRING PRIOR TO USE IN THE PATIENT WAS NOTED. FURTHER ASSESSMENT/INVESTIGATION OF THIS ISSUE PER SITE OPERATING PROCEDURES IS CURRENTLY ONGOING. CORRECTIVE AND PREVENTIVE ACTIONS TO ADDRESS THIS ISSUE WILL BE CONDUCTED AS APPROPRIATE AND THE PERFORMANCE OF DEVICES WILL CONTINUE TO BE MONITORED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. THE INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE XIENCE XPEDITION STENT DELIVERY SYSTEM (SDS) WAS PREPARED FOR USE WHEN IT WAS NOTED THAT THERE WAS NO STENT ON THE SDS. THE STENT WAS FOUND INSIDE THE SHEATH. THIS OCCURRED DURING DEVICE PREPARATION AND THERE WAS NO PATIENT INVOLVEMENT. ANOTHER XIENCE XPEDITION WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244930 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2102441

    Patients

    Seq Age Sex Outcome Treatment
    1