BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRYTON SIDE BRANCH STENT

    MDR report key: 8056886 · Received November 9, 2018

    Report

    Report Number
    3007210870-2018-00015
    Event Type
    Malfunction
    Date Received
    November 9, 2018
    Date of Event
    October 9, 2018
    Report Date
    October 15, 2018
    Manufacturer
    TRYTON MEDICAL, INC.
    Product Code
    MAF
    UDI-DI
    00894588002187
    PMA / PMN Number
    P150039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHODS: DELIVERY SYSTEM BUT NOT STENT RETURNED FOR EVALUATION. RESULTS: NO MATERIAL OF MANUFACTURING DEFECTS WERE FOUND DURING 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). CONCLUSION: THE DOCTOR REPORTED THAT THE VESSEL TO BE STENTED (CIRCUMFLEX ARTERY) WAS HIGHLY TORTUOUS SO MUCH SO THAT HE WAS UNABLE TO GET THE GUIDE SEATED COAXIALLY. AFTER HE WAS UNABLE TO DELIVER THE TRYTON IN THE TARGET LESION, THE STENT HUNG UP ON THE LOWER EDGE OF THE GUIDE WHEN HE WAS ATTEMPTING TO WITHDRAW THE STENT CATHETER RESULTING IN THE TRYTON BECOMING DISLODGED FROM THE STENT BALLOON. A FOLLOW UP FOREIGN BODY REMOVAL PROCEDURE WAS PERFORMED AND THE TRYTON WAS SUCCESSFULLY RETRIEVED." IFU CONTRAINDICATIONS STATES: "TARGET LESIONS THAT HAVE EXCESSIVE TORTUOSITY [ARE] UNSUITABLE FOR STENT DELIVERY AND DEPLOYMENT.' IFU INSTRUCTIONS FOR USE OF THE TRYTON STATES, "...IF REMOVAL OF THE ENTIRE SYSTEM WITH THE GUIDING CATHETER AS A SINGLE UNIT IS NOT CLINICALLY FEASIBLE...ENSURE THE GUIDING CATHETER IS: COAXIAL WITH THE TRYTON SIDE BRANCH STENT/STENT DELIVERY SYSTEM...FAILURE TO FOLLOW THESE STEPS...CAN RESULT IN LOSS OR DAMAGE TO THE STENT..." HIGH CALCIFICATION WAS REPORTED. "VESSELS THAT HAVE MODERATE TO SEVERE CALCIFICATION" ARE CONTRAINDICATED IN THE IFU. THE RETURNED DEVICE HAD A PREVIOUSLY INFLATED BALLOON. REVIEW OF THE REPORTED ISSUE AND EVALUATION OF THE RETURNED DEVICE WERE UNABLE TO DETERMINE AT WHAT POINT IN TIME THAT THE BALLOON INFLATION OCCURRED. INFLATING AND DEFLATING THE BALLOON PREMATURELY WILL RESULT IN THE STENT SEPARATING FROM THE BALLOON AND DISLODGING. THE IFU WARNINGS LISTS THE FOLLOWING RISK ASSOCIATED PCI, "STENT DISLODGEMENT FROM BALLOON SURFACE DURING DEPLOYMENT AND/OR DISLODGMENT FROM THE TARGET SITE POST-DEPLOYMENT CAN OCCUR." THE FOLLOWING MAY HAVE CONTRIBUTED TO THE REPORT OF STENT DISLODGMENT: HIGH CALCIFICATION OF LESION, AND/OR. HIGHLY TORTUOUS CIRCUMFLEX ARTERY, AND/OR. THE GUIDING CATHETER NOT BEING COAXIAL WITH THE TRYTON STENT/STENT DELIVERY SYSTEM, AND/OR PREMATURE INFLATION/DEFLATION OF THE BALLOON.

    Description of Event or Problem · 1

    ATTEMPTING TO CROSS AND STENT A TORTUOUS CIRC OVER A RUNTHROUGH WIRE, THROUGH A 6FR XBLAD VIA RADIAL ACCESS. TRYTON WOULD NOT CROSS EVEN AFTER AGGRESSIVE PREDIL[ATION]. WHILE REMOVING TRYTON THE STENT BECAME DISLODGED FROM THE BALLOON CATHETER. PHYSICIAN THEN LOST WIRE ACCESS AND THE DISLODGED STENT LODGED IN THE THORACIC BRANCH. PHYSICIAN WENT IN TWO DAYS LATER AND WAS SUCCESSFUL IN SNARING AND REMOVING THE DISLODGED TRYTON. THERE WAS NO INJURY. THE BIFURCATION LESION WAS TREATED VIA STANDARD PROVISIONAL APPROACH. A FOLLOW-UP DISCUSSION WITH THE PHYSICIAN CONFIRMED THAT THE CIRCUMFLEX ARTERY THAT WAS TO BE STENTED WITH THE TRYTON WAS HIGHLY TORTUOUS, SO MUCH SO THAT HE WAS UNABLE TO GET THE GUIDE SEATED COAXIALLY. AFTER HE WAS UNABLE TO DELIVER THE TRYTON IN THE TARGET LESION, THE STENT HUNG UP ON THE LOWER EDGE OF THE GUIDE WHEN HE WAS ATTEMPTING TO WITHDRAW THE STENT CATHETER RESULTING IN THE TRYTON BECOMING DISLODGED FROM THE STENT BALLOON. A FOLLOW UP FOREIGN BODY REMOVAL PROCEDURE WAS PERFORMED AND THE TRYTON WAS SUCCESSFULLY RETRIEVED. THERE WAS NO PATIENT INJURY. WHAT WAS THE TARGET LESION (MV AND SB)? LMA / CIR 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 CTO WHAT WAS THE DEGREE OF CALCIFICATION (NONE/LOW/ MEDIUM/HIGH)? HIGH WHAT WAS THE DEGREE OF TORTUOSITY (NONE/LOW/MEDIUM/HIGH)? HIGH WHAT GUIDE CATHETER (SIZE AND TYPE) WAS USED? 6FR XBLAD DID THE DEVICE PREP NORMALLY (I.E. MAINTAIN NEGATIVE PRESSURE)? NORMAL PREP WAS THERE ANY RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE ROTATING HEMOSTATIC VALVE? NONE NOTED. WAS THERE ANY RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER? NONE NOTED. WAS PREDILATATION PERFORMED PRIOR TO ATTEMPTING TO PLACE THE TRYTON STENT? YES, MULTIPLE PREDILATATIONS PERFORMED. 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, DURING PREDIL 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.). NOT APPLICABLE; ONLY ONE TRYTON DEVICE ATTEMPTED. WAS A SUBSEQUENT TRYTON STENT SUCCESSFULLY DEPLOYED AT THE INTENDED SITE? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    896877 TRYTON SIDE BRANCH STENT BARE METAL CORONARY STENT MAF TRYTON MEDICAL, INC. UFG25B1000 00894588002187

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R