BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRYTON SIDE BRANCH STENT

    MDR report key: 8056905 · Received November 9, 2018

    Report

    Report Number
    3007210870-2018-00016
    Event Type
    Malfunction
    Date Received
    November 9, 2018
    Date of Event
    October 28, 2018
    Report Date
    October 29, 2018
    Manufacturer
    TRYTON MEDICAL, INC.
    Product Code
    MAF
    UDI-DI
    00894588002132
    PMA / PMN Number
    P150039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    METHODS: DELIVERY SYSTEM BUT NOT STENT RETURNED FOR EVALUATION. RESULTS: NO MATERIAL OR MANUFACTURING DEFECTS WERE FOUND DURING THE REVIEW OF MANUFACTURING RECORDS OR DURING EVALUATION OF THE RETURNED DEVICE (MINUS STENT). NO FINDINGS AVAILABLE FOR STENT SINCE IT WAS NOT RETURNED. TREND ANALYSIS DOES NOT SHOW AN UNFAVORABLE TREND REQUIRING REPORTING PER FDA REQUIREMENTS 21 CFR 803.3(2) AND 803.53(A). CONCLUSIONS: IT WAS REPORTED THAT THE LEFT MAIN (CIR/OM3) WAS BEING STENTED. STENTING OF THE LEFT MAIN IS NOT AN INDICATION FOR USE FOR THE TRYTON DEVICE. "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. IT WAS REPORTED THAT THE PATIENT TO TOOK A LARGE BREATH PULLING BACK THE GUIDE, WIRES AND TRYTON. THE PHYSICIAN PULLED THE TRYTON BACK IN THE GUIDE TO REWIRE AND THAT IS WHEN IT WAS DISCOVERED THAT THE STENT HAD BEEN DISLODGED FROM THE BALLOON. THIS MAY HAVE BEEN A CONTRIBUTOR TO THE REPORTED ISSUE.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS PERFORMING A TRYTON PROCEDURE WHEN THE STENT CAME OFF OF THE BALLOON IN THE LM. THE TRYTON STENT WAS ACROSS THE LESION WITH NO ISSUES. THE PATIENT [TOOK] A LARGE BREATH PULLING BACK THE GUIDE, WIRES AND TRYTON. THE PHYSICIAN PULLED THE TRYTON BACK IN THE GUIDE TO REWIRE AND THAT IS WHEN IT WHEN IT WAS DISCOVERED THAT THE STENT HAD BEEN DISLODGED FROM THE BALLOON. THE PHYSICIAN WAS ABLE TO SNARE THE DISLODGED STENT AND REMOVE IT THROUGH THE RADIAL ARTERY. A NEW TRYTON STENT WAS USED TO COMPLETE THE PROCEDURE. WHAT WAS THE TARGET LESION (MV AND SB)? CIRC AND OM3. WHAT WAS THE MEDINA CLASSIFICATION? 1,1,1. WHAT WAS PERCENT STENOSIS? 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)? MEDIUM. WHAT WAS THE DEGREE OF TORTUOSITY (NONE/LOW/MEDIUM/HIGH)? MEDIUM. WHAT GUIDE CATHETER (SIZE AND TYPE) WAS USED? EBU 4 6 FR. DID THE DEVICE PREP NORMALLY (I.E. MAINTAIN NEGATIVE PRESSURE)? WAS NOT PREPPED YET. FOLLOW-UP RESPONSE FROM THE SALES REP: THE DEVICE WAS NOT PREPPED AT ALL IN OR OUT OF THE BODY PRIOR TO COMING OFF THE BALLOON. 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? SOME DUE TO THE GUIDE NOT STAYING SEATED WELL IN THE ARTERY. WAS THERE DIFFICULTY CROSSING THE LESION? NO. WERE MULTIPLE DILATATIONS PERFORMED DURING THE ATTEMPT TO PLACE THE TRYTON STENT? NO. ONE PREDILATATION. [?] THE TRYTON DID NOT HAVE DIFFICULTY RECROSSING. WAS THE TRYTON STENT REMOVED BETWEEN DILATATIONS? IF SO, HOW MANY TIMES WAS IT REMOVED AND WAS IT CHECKED VISUALLY FOR DISTORTION/DAMAGE? NO. IF MULTIPLE TRYTON DEVICES WERE USED DURING THE PROCEDURE, INCLUDE DEVICE SIZES USED (EX. 2.5/3.5, 2.5/3.0, ETC.). 2 DEVICES WERE USED: THE DISLODGED DEVICE WHICH WAS A 2.5X3.0 AND A SECOND DEVICE TO COMPLETE THE PROCEDURE WHICH WAS ALSO A 2.5X3.0. WAS A SUBSEQUENT TRYTON STENT SUCCESSFULLY DEPLOYED AT THE INTENDED SITE? YES. WHAT WAS THE FINAL PATIENT OUTCOME? PATENT ARTERIES. PATIENT RESTING COMFORTABLY AFTER PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    897002 TRYTON SIDE BRANCH STENT BARE METAL CORONARY STENT MAF TRYTON MEDICAL, INC. UBD24B1000 00894588002132

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention