BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 4792592 · Received May 22, 2015

    Report

    Report Number
    2024168-2015-02933
    Event Type
    Malfunction
    Date Received
    May 22, 2015
    Date of Event
    April 27, 2015
    Report Date
    April 28, 2015
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: CONCOMITANT PRODUCTS: GUIDE WIRE: SION; OTHER: GUIDELINER V3 6F. THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED DIFFICULTY TO POSITION WAS UNABLE TO BE CONFIRMED. THE REPORTED DIFFICULTY TO REMOVE WAS UNABLE TO BE CONFIRMED. BASED ON A VISUAL, DIMENSIONAL 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 OF THE ELECTRONIC COMPLAINT DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FOR DIFFICULT TO POSITION OR DIFFICULT TO REMOVE FROM THIS LOT. 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 DE NOVO, ECCENTRIC LESION IN THE PROXIMAL CIRCUMFLEX ARTERY WITH MILD TORTUOSITY, MILD CALCIFICATION AND 80% STENOSED. A 3.25X18MM RX XIENCE ALPINE STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION WITH A NON-ABBOTT GUIDING CATHETER EXTENSION. HOWEVER, DUE TO THE ANGULAR TORTUOSITY FROM THE LEFT MAIN TRUNK TO THE LEFT CIRCUMFLEX ARTERY RESISTANCE WAS MET WITH THE NON-ABBOTT GUIDING CATHETER EXTENSION AND THE SDS GOT STUCK. THUS, THE SDS WAS REMOVED BY ITSELF FROM THE PATIENT ANATOMY AND SLIGHT RESISTANCE WAS FELT WITH THE NON-ABBOTT GUIDING CATHETER EXTENSION. A 3.0X20MM NON-ABBOTT SDS WAS USED TO COMPLETE THE PROCEDURE AFTER STENTING. THERE WERE NO REPORTED 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
    333875 XIENCE ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 5020941

    Patients

    Seq Age Sex Outcome Treatment
    1 CONCOMITANT MEDICAL DEVICES