BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRYTON SIDE BRANCH STENT

    MDR report key: 8470809 · Received April 1, 2019

    Report

    Report Number
    3007210870-2019-00001
    Event Type
    Injury
    Date Received
    April 1, 2019
    Date of Event
    February 22, 2019
    Report Date
    February 24, 2019
    Manufacturer
    TRYTON MEDICAL, INC.
    Product Code
    MAF
    UDI-DI
    00894588002132
    PMA / PMN Number
    P150039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT HAD A SEPTAL BRANCH DISTALLY TO THE BIFURCATION. THE SEPTAL BRANCH BECAME OCCLUDED DURING THE PROCEDURE AND WAS JAILED OFF DUE TO THE MAIN BRANCH STENT. THE PATIENT STATED SHE HAD CHEST PAIN THAT LASTED LESS THAN 1 MINUTE DURING THE PROCEDURE. THE TRYTON STENT WAS A SUCCESS AND THE PATIENT LEFT THE CATH LAB FOR POST-OP RECOVERY. THE PHYSICIAN FELT IT WAS BEST TO ADMIT THE PATIENT FOR OBSERVATION. THE PATIENT WAS DOING WELL AND DISCHARGED ON (B)(6) 2019. THEY'RE CALLING IT A NSTEMI TYPE 4A. WHAT WAS THE TARGET LESION (MV AND SB)? MV - LAD, SB - DIAG. WHAT WAS THE MEDINA CLASSIFICATION? 1.1.1. WHAT WAS PERCENT STENOSIS? MV - 90%, SB - 90%. WAS THE DEVICE USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION > 3 MONTHS)? NO. WHAT WAS THE DEGREE OF CALCIFICATION (NONE/LOW/MEDIUM/HIGH)? NONE TO LOW. WHAT WAS THE DEGREE OF TORTUOSITY (NONE/LOW/MEDIUM/HIGH)? NONE. WHAT GUIDE CATHETER (SIZE AND TYPE) WAS USED? 6 FR - BOSTON SCIENTIFIC RUNWAY VL3 GUIDE CATHETER. 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? NO. WAS THERE DIFFICULTY CROSSING THE LESION? ONLY DURING THE POST-DILATION BUT WAS ABLE TO CROSS WITH ANOTHER BALLOON SIZE. 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? NO. WHAT WAS THE FINAL PATIENT OUTCOME? MV - LESS THAN 10%, SB - LESS THAN 10%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263994 TRYTON SIDE BRANCH STENT BARE METAL CORONARY STENT MAF TRYTON MEDICAL, INC. UBH22B1000 00894588002132

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| L ASPIRIN - 81MG - QPM| CAPTOPRIL - 50MG - TID| CLOPIDOGREL - 75MG - QD| EZETIMIBE - 10MG - QD| METFORMIN - 500MG - BID| METOPROLOL SUCCINATE - 25MG - QD| NIFEDIPINE - 90 MG - QD| NITROGLYCERIN - 0.4MG - PRN| SIMVASTATIN - 20MG - QPM| TRIAMTERENE-HYDROCHLOROTHIAZIDE - 37.5-25MG - QD