BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 7822548 · Received August 28, 2018

    Report

    Report Number
    2024168-2018-06659
    Event Type
    Malfunction
    Date Received
    August 28, 2018
    Date of Event
    August 15, 2018
    Report Date
    August 28, 2018
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    UDI-DI
    08717648199530
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL DEVICES: GUIDE WIRE: RUNTHROUGH NS, GUIDE CATHETER: HYPERION 6FR JL 3.5. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. THE INVESTIGATION DETERMINED THAT THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE OR LABELING OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS, ECCENTRIC AND HEAVILY CALCIFIED PROXIMAL LEFT CIRCUMFLEX ARTERY THAT WAS 99% STENOSED. PRE-DILATATION WAS PERFORMED WITH A NON-ABBOTT BALLOON DILATATION CATHETER. AN ATTEMPT WAS THEN MADE TO ADVANCE A 3.5 X 18 MM XIENCE ALPINE STENT DELIVERY SYSTEM (SDS); HOWEVER, IT FAILED TO CROSS THE LESION DUE TO THE ANATOMY. ADDITIONALLY, THERE WAS DIFFICULTY IN REMOVING THE DEVICE DUE TO THE ANATOMY AND THE DEVICE WAS REMOVED INDEPENDENTLY. THE SDS WAS THEN REPLACED WITH A 3.5 X 18 MM NON-ABBOTT SDS 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
    664143 XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 7081561 08717648199530

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR