BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3771556 · Received April 24, 2014

    Report

    Report Number
    2024168-2014-02587
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 3, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE LEAK AND INFLATION FAILURE WERE CONFIRMED WITH OTHER OBSERVATIONS. BASED ON A VISUAL AND FUNCTIONAL INSPECTION ANALYSIS 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 OF THE COMPLAINT HANDLING DATABASE REVEALED NO OTHER INCIDENTS FOR LEAKS OR FOR INFLATION ISSUES REPORTED FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 80% STENOSED BELOW BIFURCATION DIAGONAL ARTERY. A 2.5 X 8 MM XIENCE PRIME WAS ADVANCED TO THE LESION AND WHEN ATTEMPTING TO INFLATE THE BALLOON, CONTRAST LEAKED OUT THE DISTAL END OF THE BALLOON AND THE BALLOON DID NOT INFLATE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER XIENCE STENT DELIVERY SYSTEM. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249373 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2032741

    Patients

    Seq Age Sex Outcome Treatment
    1