BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3951270 · Received July 22, 2014

    Report

    Report Number
    2024168-2014-04701
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    June 30, 2014
    Report Date
    July 2, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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/REVIEW OF THE COMPLAINT DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF THE RIGHT CORONARY ARTERY (RCA) THE XIENCE XPEDITION STENT WAS DEPLOYED PROXIMAL AND A 3.5 X 18 MM XIENCE XPEDITION STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO DELIVER THE STENT DISTAL TO THE PROXIMAL STENT JUST PLACED, HOWEVER, WHEN THE SDS EXITED THE GUIDE CATHETER BEFORE REACHING THE FIRST STENT, THE IMPLANT BECAME DISLODGED DISTALLY FROM THE BALLOON. A NON-ABBOTT BALLOON DILATATION CATHETER (BDC) WAS USED TO CAPTURE THE STENT IMPLANT AND PULL IT INTO THE GUIDE CATHETER. ALL OF THE DEVICES AND STENT IMPLANT WERE REMOVED TOGETHER INSIDE THE GUIDE CATHETER. THE PROCEDURE WAS STOPPED AT THIS POINT WITHOUT REPORTED 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
    428051 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 4012341

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention