BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3930409 · Received July 11, 2014

    Report

    Report Number
    2024168-2014-04481
    Event Type
    Malfunction
    Date Received
    July 11, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 20, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE INFLATION ISSUE AND LEAK WERE ABLE TO BE CONFIRMED. BASED ON A VISUAL AND FUNCTIONAL INSPECTION OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A QUERY/REVIEW OF THE ELECTRONIC COMPLAINT DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FOR INFLATION ISSUES OR LEAKS FROM THIS LOT. IT SHOULD BE NOTED THE XIENCE PRIME, XIENCE PRIME SMALL VESSEL (SV), AND XIENCE PRIME LONG LENGTH (LL) EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) STATES: PREPARE AN INFLATION DEVICE/SYRINGE WITH DILUTED CONTRAST MEDIUM. ATTACH AN INFLATION DEVICE/SYRINGE TO THE STOPCOCK; ATTACH IT TO THE INFLATION PORT. WITH THE TIP DOWN, ORIENT THE DELIVERY SYSTEM VERTICALLY. OPEN THE STOPCOCK TO DELIVERY SYSTEM; PULL NEGATIVE FOR 30 SECONDS; RELEASE TO NEUTRAL FOR CONTRAST FILL. CLOSE THE STOPCOCK TO THE DELIVERY SYSTEM; PURGE THE INFLATION DEVICE/SYRINGE OF ALL AIR. REPEAT STEPS UNTIL ALL AIR IS EXPELLED. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED LESION IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. AFTER PLACEMENT OF A NON-ABBOTT GUIDE WIRE, THE LESION WAS PRE-DILATATED WITH A 2.0X20MM NON-ABBOTT BALLOON DILATATION CATHETER (BDC). THE 2.5X28MM XIENCE PRIME STENT DELIVERY SYSTEM (SDS) WAS NOT PREPPED OUTSIDE THE PATIENT'S ANATOMY PRIOR TO USE. THE XIENCE PRIME SDS WAS SUCCESSFULLY ADVANCED TO THE LESION; HOWEVER, BLOOD WAS NOTED IN THE INFLATION DEVICE AND THE SDS FAILED TO INFLATE. A BALLOON RUPTURE WAS SUSPECTED, THUS THE SDS WAS REMOVED WITHOUT REPORTED ISSUE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A 2.5X30MM NON-ABBOTT SDS WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406309 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 3041541

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR GUIDE WIRE: RUNTHROUGH FLOPPY