BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRYTON SIDE BRANCH STENT

    MDR report key: 7957965 · Received October 11, 2018

    Report

    Report Number
    3007210870-2018-00014
    Event Type
    Injury
    Date Received
    October 11, 2018
    Date of Event
    September 27, 2018
    Report Date
    October 1, 2018
    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
    003

    Narratives

    Additional Manufacturer Narrative · 1

    RECEIVED LIMITED INFORMATION THAT A SERIOUS ADVERSE EVENT HAD OCCURRED ON (B)(6) 2018. HOWEVER, MANUFACTURER WAS NOT AWARE THAT EVENT MAY HAVE BEEN RELATED TO TRYTON DEVICE UNTIL 10/1/2018. THEREFORE, MANUFACTURER CONSIDERS 10/1/2018 TO BE THE AWARE DATE. RESULTS: TREND ANALYSIS DID NOT REVEAL AN UNFAVORABLE TREND. EXAMINATION OF THE LOT HISTORY RECORD SHOWED THAT THE LOT PASSED ALL ACCEPTANCE CRITERIA.

    Description of Event or Problem · 1

    PATIENT PRESENTED WITH UNSTABLE ANGINA. CATHETERIZATION SHOWED 70-80% IN-STENT RESTENOSIS IN THE DIAG. DIAG WAS A SMALL VESSEL WHICH WAS DECIDED TO TREAT MEDICALLY. RELATION TO TRYTON DEVICE WAS DESCRIBED BY INVESTIGATOR AS "HIGHLY PROBABLE." PATIENT OUTCOME WAS RECOVERED/RESOLVED WITH SEQUELAE. WHAT WAS THE TARGET LESION (MV AND SB)? MV - 13-MID LAD, SB - 15-1ST DIAG. WHAT WAS THE MEDINA CLASSIFICATION? 0,1,1. WHAT WAS PERCENT STENOSIS? MV - 90%, SB - 80%. 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. WHAT WAS THE DEGREE OF TORTUOSITY (NONE/LOW/MEDIUM/HIGH)? NONE. WHAT GUIDE CATHETER (SIZE AND TYPE) WAS USED? 6F FORTE. 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? NONE. WAS THERE ANY RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER? NONE. 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? NO. WERE MULTIPLE DILATATIONS PERFORMED DURING THE ATTEMPT TO PLACE THE TRYTON STENT? NO. WHAT WAS THE FINAL PATIENT OUTCOME? MV - 0%, SB - 0%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797618 TRYTON SIDE BRANCH STENT BARE METAL CORONARY STENT MAF TRYTON MEDICAL, INC. UBC01B1000 00894588002132

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R