BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3840768 · Received May 30, 2014

    Report

    Report Number
    2024168-2014-03456
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    April 28, 2014
    Report Date
    May 6, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT ESTIMATED. DATE OF TESTS ESTIMATED. THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS INITIALLY REPORTED THAT THE DEVICE WOULD BE RETURNED FOR ANALYSIS. SUBSEQUENT INFORMATION REVEALED THAT THE DEVICE WAS DISCARDED AND IS NOT AVAILABLE FOR EVALUATION. 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 OF THE ELECTRONIC COMPLAINT DATABASE REVEALED NO OTHER INCIDENTS REPORTED FOR SEPARATIONS FROM THIS LOT. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ADVANCEMENT OF THE 2.5X38MM XIENCE PRIME STENT DELIVERY SYSTEM (SDS) INTO THE ANATOMY, THE BALLOON OF THE SDS FRACTURED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO FILING THE INITIAL MDR, ADDITIONAL INFORMATION WAS RECEIVED. THEREFORE, THE CASE DETAILS HAVE BEEN UPDATED ACCORDINGLY: IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED LESION IN THE CIRCUMFLEX (CX) ARTERY. DURING ADVANCEMENT OF THE 2.5X38MM XIENCE PRIME STENT DELIVERY SYSTEM (SDS), ALTHOUGH NO RESISTANCE WAS NOTED, THE SHAFT SEPARATED. IT WAS NOT REPORTED HOW THE SEPARATED SHAFT WAS RETRIEVED; HOWEVER, IT WAS REPORTED THAT THERE WAS NO RESISTANCE DURING WITHDRAWAL AND IT WAS REPORTED THAT THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANOTHER 2.5X38MM XIENCE PRIME SDS WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318811 XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 3071641

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR