BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRYTON SIDE BRANCH STENT

    MDR report key: 11847605 · Received May 19, 2021

    Report

    Report Number
    3016248656-2021-00001
    Event Type
    Malfunction
    Date Received
    May 19, 2021
    Date of Event
    April 13, 2021
    Report Date
    April 13, 2021
    Manufacturer
    POSEIDON MEDICAL, INC.
    Product Code
    MAF
    PMA / PMN Number
    P150039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THERE MAY HAVE BEEN AN ATTEMPT TO REMOVE THE STENT WITHOUT REMOVING THE CATHETER. THE IFU STATES THE FOLLOWING UNDER PRECAUTIONS: "DO NOT ATTEMPT TO PULL AN UNEXPANDED STENT BACK INTO THE GUIDING CATHETER, AS STENT DAMAGE OR STENT DISLODGEMENT MAY OCCUR. MOVEMENT IN AND OUT THROUGH THE DISTAL END OF THE GUIDING CATHETER SHOULD NOT BE PERFORMED AS THE STENT MAY BE DAMAGED WHEN RETRACTING THE UNDEPLOYED STENT BACK INTO THE GUIDING CATHETER. TO WITHDRAW THE TRYTON SIDE BRANCH STENT SYSTEM, THE ENTIRE SYSTEM WITH THE GUIDING CATHETER SHOULD BE REMOVED AS A SINGLE UNIT."

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSIONS: BIFURCATION WAS DESCRIBED AS "VERY CALCIFIED." VESSELS THAT HAVE "MODERATE OR SEVERE CALCIFCATION" ARE CONTRAINDICATED IN THE IFU. BECAUSE THE DEVICE WAS IMPLANTED AND NOT AVAILABLE FOR EVALUATION, A DEFINITIVE CONCLUSION COULD NOT BE REACHED.

    Description of Event or Problem · 1

    THE DOCTOR WAS TREATING AN LAD/DIAGONAL BIFURCATION THAT WAS VERY CALCIFIED USING A RADIAL APPROACH. HE HAD USED ROTATIONAL ATHERECTOMY AND PRE-DILATED THE LAD WITH A 3.5MM BALLOON PRIOR TO INSERTING THE TRYTON STENT. HE COULD NOT REACH THE LESION WITH THE TRYTON STENT. HE WITHDREW THE TRYTON STENT AND HE ATTEMPTED TO PRE-DILATE THE DIAGONAL WITH A 3.0MM BALLOON. HE ADVANCED THE TRYTON STENT AGAIN AND COULD NOT GET THROUGH. AS HE WITHDREW THE STENT, HE FELT THAT IT CAUGHT ON SOMETHING, HE BELIEVES THE EDGE OF THE GUIDING CATHETER. THE STENT WAS DISLODGED FROM THE BALLOON AND WAS FOUND IN THE LCX. THERE WAS A LESION IN THE LCX THAT HE HAD PLANNED TO TREAT SO HE USED A 4.0 DRUG-ELUTING STENT IN THE LCX, CRUSHING THE DISLODGED TRYTON STENT BEHIND IT. THE DELIVERY SYSTEM WAS DISCARDED AND WILL NOT BE RETURNED. THE PATIENT WAS DOING FINE WITH NO APPARENT CONSEQUENCES OR CHEST PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748246 TRYTON SIDE BRANCH STENT BARE METAL CORONARY STENT MAF POSEIDON MEDICAL, INC. UGB26E1000

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| R