BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3930261 · Received July 11, 2014

    Report

    Report Number
    2024168-2014-04469
    Event Type
    Injury
    Date Received
    July 11, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 18, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DISTAL PART OF THE LESION WAS SUCCESSFULLY IMPLANTED WITH A 3.0 X 8 MM XIENCE XPEDITION STENT. THE PATIENT IS FINE. THERE WAS A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. CONCOMITANT MEDICAL PRODUCTS: GUIDE WIRE: BMW ELITE, FLOPPY EXTRA SUPPORT. 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 AND COMPLAINT HISTORY OF THE REPORTED LOT COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. THE OTHER XIENCE XPEDITION REFERENCED IS BEING FILED UNDER A SEPARATE MANUFACTURING REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE ANASTOMOSIS WHERE A VENOUS BYPASS AND THE POSTERIOR RIGHT CORONARY JOINED. THE LESION WAS AT THE ANASTOMOSIS AND IN THE POSTERIOR INTRAVENTRICULAR (PIV) ARTERY IN THE RIGHT CORONARY. A BALANCE MIDDLEWEIGHT (BMW) ELITE GUIDE WIRE WAS POSITIONED AND PRE-DILATATION WAS PERFORMED WITH A 2.0 X 15 MM AND A 3.0 X 20 MM UNKNOWN BALLOON CATHETERS. A 3.0 X 28 MM XIENCE XPEDITION STENT DELIVERY SYSTEM (SDS) COULD NOT CROSS THE LESION. A SECOND UNKNOWN GUIDE WIRE WAS POSITIONED FOR MORE SUPPORT (BUDDY WIRE). THE SAME XIENCE XPEDITION WAS ADVANCED BUT IT STILL COULD NOT CROSS THE LESION. THE SDS AND BOTH GUIDE WIRES WERE REMOVED FROM THE ANATOMY AND A FLOPPY EXTRA SUPPORT GUIDE WIRE WAS PLACED. THE SAME 3.0 X 28 MM XIENCE XPEDITION CROSSED THE LESION AND WAS IMPLANTED; HOWEVER, IT COULD NOT BE ADVANCED COMPLETELY INTO THE LESION WITH A SMALL PORTION IMPLANTED IN HEALTHY TISSUE. IT DID NOT COVER THE ENTIRE LESION. POST-DILATATION WAS PERFORMED WITH A 3.0 X 15 MM UNKNOWN NC BALLOON CATHETER. A 3.0 X 12 MM XIENCE XPEDITION SDS WAS BEING ADVANCED TO COVER THE DISTAL PORTION OF THE LESION, BUT IT COULD NOT CROSS. THERE WAS A LOT OF FORCE APPLIED IN THE ATTEMPT TO CROSS THE LESION AND A SECOND GUIDE WIRE WAS POSITIONED (BUDDY WIRE) BUT THE SDS STILL COULD NOT CROSS. DURING REMOVAL OF THE SDS, THE STENT IMPLANT DISLODGED AND REMAINED IN THE MEDIUM TRACT OF THE BYPASS WHERE IT WAS SUCCESSFULLY APPOSED TO THE VESSEL WALL WITH A 2.0 X 15 MM UNKNOWN BALLOON CATHETER, THE STENT DELIVERY SYSTEM OF THE DISLODGED STENT, AND A 4.0 X 15 MM UNKNOWN BALLOON CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405939 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SEE H10 FOR CONCOMITANT MEDICAL DEVICES