BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRYTON SIDE BRANCH STENT

    MDR report key: 8575096 · Received May 2, 2019

    Report

    Report Number
    3007210870-2019-00003
    Event Type
    Malfunction
    Date Received
    May 2, 2019
    Date of Event
    April 17, 2019
    Report Date
    April 22, 2019
    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

    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 TO SEVERE CALCIFICATION" ARE CONTRAINDICATED IN THE IFU. THE MEDIUM LEVEL OF CALCIFICATION MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE. CHRONIC TOTAL OCCLUSION (CTO) OF THE MAIN BRANCH (RCA) WAS REPORTED. "VESSELS THAT ARE TOTALLY OCCLUDED..." ARE CONTRAINDICATED IN THE IFU. THE TOTALLY OCCLUDED VESSEL MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE. PRODUCTION RECORDS AND TREND ANALYSIS WERE REVIEWED WITH NO DEVICE PROBLEM FOUND. BECAUSE THE DEVICE WAS NOT AVAILABLE FOR TESTING, A DEFINITIVE CONCLUSION COULD NOT BE REACHED.

    Description of Event or Problem · 1

    UPON ATTEMPTING TO INSERT THE [TRYTON] STENT IT BECAME DISLODGED FROM THE BALLOON AND SETTLED INTO THE PATIENT'S RIGHT CORONARY ARTERY. ATTEMPTS WERE MADE TO SNARE THE STENT BUT WERE UNSUCCESSFUL SO THE PHYSICIAN CRUSHED IT WITH ANOTHER STENT. THERE WAS NO PATIENT INJURY. WHAT WAS THE TARGET LESION (MV AND SB)? RCA AND PLV [POSTERIOR LEFT VENTRICULAR ARTERY] WHAT WAS THE MEDINA CLASSIFICATION? 1,1,1. WHAT WAS PERCENT MV AND SB STENOSIS? MB 100% CTO, SB 60%. WAS THE DEVICE USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION > 3 MONTHS)? MAIN BRANCH CTO. SB NO CTO. 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? 6F EBU. 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? YES, ONCE THE STENT EXITED THE GUIDE THERE WAS RESISTANCE AT THE RCA OSTIUM. 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? DEVICE DID NOT REACH LESION. WERE MULTIPLE DILATATIONS PERFORMED DURING THE ATTEMPT TO PLACE THE TRYTON STENT? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368562 TRYTON SIDE BRANCH STENT BARE METAL CORONARY ARTERY MAF TRYTON MEDICAL, INC. :UBK21B1000 00894588002132

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention