BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3981581 · Received August 5, 2014

    Report

    Report Number
    2024168-2014-04958
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    May 2, 2014
    Report Date
    July 16, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE SHAFT SEPARATION AND KINKS WERE ABLE TO BE CONFIRMED. THE FAILURE TO ADVANCE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON A VISUAL AND DIMENSIONAL 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 FROM THIS LOT. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    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 TREATING A MILDLY TORTUOUS, MODERATELY CALCIFIED, 80% STENOSED, DE NOVO LESION IN THE DISTAL LEFT ANTERIOR DESCENDING CORONARY ARTERY. AFTER PRE-DILATATION, THE 2.5X18MM XIENCE PRIME STENT DELIVERY SYSTEM (SDS) WAS ADVANCED; HOWEVER, FAILED TO CROSS THE LESION DUE TO THE PATIENT ANATOMY. MULTIPLE ATTEMPTS TO CROSS WERE MADE AND THE PROXIMAL SHAFT BECAME BENT AND SEPARATED. THE BEND AND SEPARATION OCCURRED ON THE SECTION OF THE DEVICE WHICH WAS OUTSIDE THE PATIENT ANATOMY. THE DEVICE WAS REMOVED AND ANOTHER SDS WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456638 XIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 3092641

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR