BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRYTON SIDE BRANCH STENT

    MDR report key: 10324413 · Received July 26, 2020

    Report

    Report Number
    3007210870-2020-00002
    Event Type
    Malfunction
    Date Received
    July 26, 2020
    Date of Event
    July 14, 2020
    Report Date
    July 14, 2020
    Manufacturer
    TRYTON MEDICAL, INC.
    Product Code
    MAF
    UDI-DI
    00894588002132
    PMA / PMN Number
    P150039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE PROBLEM FOUND IN ANALYSIS OF PRODUCTION RECORDS OR TREND ANALYSIS. DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, NO FINDINGS WERE AVAILABLE. "MEDIUM" CALCIFICATION WAS REPORTED. VESSELS THAT HAVE "MODERATE OR SEVERE CALCIFICATION" ARE CONTRAINDICATED IN THE IFU. PRODUCTION RECORDS AND TREND ANALYSIS WERE REVIEWED WITH NO DEVICE PROBLEM FOUND. BECAUSE THE DEVICE WAS IMPLANTED AND NOT AVAILABLE FOR TESTING, A DEFINITIVE CONCLUSION COULD NOT BE REACHED. TRYTON MEDICAL, INC., TRANSFERRED OWNERSHIP OF PMA P150039 TO POSEIDON MEDICAL, INC. AS OF SEPTEMBER 30, 2019 AND NOTIFIED FDA VIA P150039/A005. BOTH POSEIDON MEDICAL, AS PMA HOLDER, AND TRYTON MEDICAL, AS MANUFACTURER, ARE OBLIGATED TO SUBMIT MDRS FOR ANY QUALIFYING EVENTS WITH THE TRYTON SIDE BRANCH STENT. THEREFORE, THIS MDR WAS ALSO SUBMITTED BY POSIEDON MEDICAL, REFERENCE MDR 3016248656-2020-00002.

    Description of Event or Problem · 1

    THE TRYTON STENT WAS ADVANCED WITH DIFFICULTY THROUGH A PROXIMAL STENOSIS, IT WAS UNABLE TO BE PASSED INTO THE OM FOR DEPLOYMENT. THE GUIDING CATHETER WAS MANIPULATED TO ENSURE A COAXIAL ORIENTATION. THE TRYTON WAS SLOWLY PULLED BACK TO THE GUIDING CATHETER AND BECAME DISLODGED FROM THE BALLOON. A SMALL DIAMETER BALLOON WAS PASSED OVER SB WIRE IN AN ATTEMPT TO CAPTURE THE STENT. THE GUIDING CATHETER AND ALL WIRES WERE REMOVED WITH THE BALLOON INFLATED IN ATTEMPT TO CAPTURE THE STENT. THE TRYTON STENT WAS JAILED IN PLACE BY ANOTHER STENT. THE DEVICE WAS PREPPED PER THE IFU. AN 8F MEDTRONIC EBU GUIDING CATHETER WAS USED. AT THE TIME OF THIS REPORT, NO ADVERSE OUTCOMES WERE NOTED AS A RESULT OF THE STENT COMING OFF THE DELIVERY BALLOON. WHAT WAS THE TARGET LESION (MV AND SB)? LEFT CX/OM. WHAT WAS THE MEDINA CLASSIFICATION? 1,1,1. WHAT WAS PERCENT MV AND SB STENOSIS? MV-70%, SB-70%. 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)? MEDIUM. 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 THERE DIFFICULTY REACHING THE LESION? YES. WAS THERE DIFFICULTY CROSSING THE LESION? YES. WERE MULTIPLE DILATATIONS PERFORMED DURING THE ATTEMPT 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? AN ATTEMPT WAS MADE TO REMOVE, BUT BECAME DISLODGED ON THIS ATTEMPT. WAS A SUBSEQUENT TRYTON STENT SUCCESSFULLY DEPLOYED AT THE INTENDED SITE? NO. WHAT WAS THE FINAL PATIENT OUTCOME? PATIENT HAD SUCCESSFUL PROCEDURE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788556 TRYTON SIDE BRANCH STENT BARE METAL CORONARY STENT MAF TRYTON MEDICAL, INC. T5-2530-191-US UBD18D1000 00894588002132

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R