BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 4200359 · Received October 24, 2014

    Report

    Report Number
    2024168-2014-06986
    Event Type
    Injury
    Date Received
    October 24, 2014
    Date of Event
    September 30, 2014
    Report Date
    October 1, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE STENT REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 DIFFICULT TO DEPLOY FROM THIS LOT. THE REPORTED PATIENT EFFECT OF THROMBOSIS, AS LISTED IN THE XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) IS A KNOWN PATIENT EFFECT THAT MAY BE ASSOCIATED WITH USE OF A CORONARY STENT IN NATIVE CORONARY ARTERIES. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 2.75X23MM XIENCE XPEDITION STENT IMPLANT WAS DEPLOYED TO TREAT A LESION IN AN UNSPECIFIED ARTERY. APPROXIMATELY ONE HOUR POST-PROCEDURE, THROMBOSIS WAS NOTED, WHICH RESOLVED. ADDITIONALLY, IT IS SUSPECTED THAT THE STENT IMPLANT MAY HAVE BEEN MALAPPOSED TO THE VESSEL WALL. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 2.75X23MM XIENCE XPEDITION STENT IMPLANT WAS DEPLOYED TO TREAT A LESION IN AN UNSPECIFIED ARTERY. APPROXIMATELY ONE HOUR POST-PROCEDURE, THROMBOSIS WAS NOTED AND IT WAS SUSPECTED THAT THE STENT IMPLANT MAY HAVE BEEN MALAPPOSED TO THE VESSEL WALL. UNSPECIFIED PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED AS TREATMENT. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679915 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 4022741

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention