BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRYTON SIDE BRANCH STENT

    MDR report key: 8108206 · Received November 27, 2018

    Report

    Report Number
    3007210870-2018-00017
    Event Type
    Malfunction
    Date Received
    November 27, 2018
    Date of Event
    November 9, 2018
    Report Date
    November 9, 2018
    Manufacturer
    TRYTON MEDICAL, INC.
    Product Code
    MAF
    UDI-DI
    00894588002132
    PMA / PMN Number
    P150039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - NO DEVICE PROBLEM FOUND IN ANALYSIS OF PRODUCTION RECORDS OR TREND ANALYSIS. DEVICE WAS NOT RETURNED FOR EVALUATION, THEREFORE NO FINDINGS WERE AVAILABLE. CONCLUSIONS - IT WAS REPORTED THAT THE LAD / DIAGONAL WAS BEING STENTED AND THAT THE TRYTON DEVICE WAS INADVERTENTLY PLACED ON THE WRONG WIRE. THE STENT DISLODGED WHEN ATTEMPTING TO REMOVE THE TRYTON THROUGH THE GUIDE. THE PRECAUTIONS SECTION OF THE IFU STATES, "DO NOT ATTEMPT TO PULL AN UNEXPANDED STENT BACK INTO THE GUIDING CATHETER, AS STENT DAMAGE OR STENT DISLODGEMENT MAY OCCUR." THE ATTEMPT TO WITHDRAW THE STENT INTO THE GUIDING CATHETER MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE. "MEDIUM" CALCIFICATION WAS REPORTED. VESSELS THAT HAVE "MODERATE TO SEVERE CALCIFICATION" ARE CONTRAINDICATED IN THE IFU. THE MEDIUM LEVEL OF CALCIFICATION MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE.

    Description of Event or Problem · 1

    A TRYTON STENT DISLODGEMENT OCCURED. THEIR INTENTION WAS TO PLACE THE TRYTON IN THE DIAG, AND A DES IN THE LAD. THEY LOADED THE TRYTON STENT ON THE LAD WIRE, WHEN THEY REALIZED IT, HE WITHDREW THE STENT BACK TO THE GUIDE, HOWEVER THE TRYTON STENT CAME OFF THE BALLOON. HE TRIED A FEW THINGS TO RETRIEVE THE STENT UNSUCCESSFULLY SO ENDED UP DEPLOYING IT IN THE LEFT MAIN/LAD. THEY COMPLETED THE CASE BY DOING A T STENT PROCEDURE WITH TWO ONYX DES'S. THE RESULT WAS GOOD (FOR A T STENT TECHNIQUE), THERE WAS NO HARM OR INJURY TO THE PATIENT. AFTER THE CASE, [THE PHYSICIAN] ACKNOWLEDGED THAT HE KNEW NOT TO PULL THE TRYTON STENT BACK INTO THE GUIDE. WHAT WAS THE MEDINA CLASSIFICATION? 1,1,1. WHAT WAS PERCENT STENOSIS? 50% DIAG, 85% LAD. WAS THE DEVICE USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION > 3 MONTHS)? NO. WHAT WAS THE DEGREE OF CALCIFICATION (NONE/LOW/MEDIUM/HIGH)? MEDIUM. WHAT WAS THE DEGREE OF TORTUOSITY (NONE/LOW/MEDIUM/HIGH)? LOW. WHAT GUIDE CATHETER (SIZE AND TYPE) WAS USED? 6F, SHAPE NOT KNOWN. DID THE DEVICE PREP NORMALLY (I.E. MAINTAIN NEGATIVE PRESSURE)? YES. WAS THERE ANY RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE? NO. WAS THERE ANY RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER? NO. WAS PREDILATATION PERFORMED PRIOR TO ATTEMPTING TO PLACE THE TRYTON STENT? YES. WAS THE TRYTON STENT REMOVED BETWEEN DILATATIONS? IF SO, HOW MANY TIMES WAS IT REMOVED AND WAS IT CHECKED VISUALLY FOR DISTORTION/DAMAGE? TRYTON STENT CAME OFF THE BALLOON WHEN THE DOCTOR ATTEMPTED TO WITHDRAW IT INTO THE GUIDE. WAS A SUBSEQUENT TRYTON STENT SUCCESSFULLY DEPLOYED AT THE INTENDED SITE? NO. A SECOND TRYTON WAS NOT ATTEMPTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    946365 TRYTON SIDE BRANCH STENT BARE METAL CORONARY STENT MAF TRYTON MEDICAL, INC. UBC01B1000 00894588002132

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention