BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3497696 · Received December 3, 2013

    Report

    Report Number
    2024168-2013-07735
    Event Type
    Malfunction
    Date Received
    December 3, 2013
    Date of Event
    November 3, 2013
    Report Date
    November 9, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    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 WAS 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. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: GUIDE WIRE: FLOPPY; GUIDE CATH: 6 F JR 3.5 CORDIS. 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 95% STENOSED LESION IN THE DISTAL RIGHT CORONARY ARTERY WITH MILD TORTUOSITY AND CALCIFICATION. THE PATIENT WAS ADMITTED WITH AN ACUTE INFERIOR WALL MYOCARDIAL INFARCTION. PRE-DILATATION WAS PERFORMED AND THE 3.0 X 23 MM XIENCE V STENT DELIVERY SYSTEM (SDS) WAS ADVANCED, BUT COULD NOT CROSS TO THE LESION DUE TO THE ANATOMY. DURING ADVANCEMENT, THE PROXIMAL SHAFT SEPARATED OUTSIDE THE PATIENT. THE SDS WAS REMOVED, AND A NEW XIENCE V SDS WAS USED SUCCESSFULLY. 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
    625813 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2112141

    Patients

    Seq Age Sex Outcome Treatment
    1