Tryton Side Branch Stent T5-2525-191-USRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00894588002125), received between Feb 16, 2018 and Mar 14, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 14, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  TRYTON DEVICE INSERTED FOR POTENTIAL TREATMENT OF LAD/DIAG. TRYTON STENT DEPLOYMENT WAS ATTEMPTED, BUT PHYSICIAN WAS UNABLE TO CROSS TRYTON SYSTEM BEYOND THE LEFT MAIN ARTERY. REMOVAL ATTEMPT RESULTED IN DISLODGMENT OF TRYTON STENT FROM TRYTON DELIVERY BALLOON. STENT NEVER REACHED THE BIFURCATION AND CAME OFF IN THE LM (LEFT MAIN). THE PHYSICIAN USED A SNARE DEVICE TO RETRIEVE UNDEPLOYED TRYTON STENT AND IT WAS SNARED SUCCESSFULLY. NO PATIENT INJURY OCCURRED. THE PATIENT RECEIVED TWO DES AND WAS DISCHARGED FROM THE HOSPITAL. OPERATOR WAS NOT TRAINED ON USE OF TRYTON. WHAT WAS THE MEDINA CLASSIFICATION? 1,1,1. WHAT WAS PERCENT STENOSIS? 90%. WHAT WAS THE DEGREE OF TORTUOSITY (NONE/LOW/MEDIUM/HIGH)? NS (NOT SIGNIFICANT). WHAT GUIDE CATHETER (SIZE AND TYPE) WAS USED? 6FR. 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? NO. WAS PREDILATATION PERFORMED PRIOR TO ATTEMPTING TO PLACE THE TRYTON STENT? YES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7337565 ↗
• MalfunctionFeb 16, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING A PERCUTANEOUS CORONARY INTERVENTION WITH A 2.5/2.5 MM X 19 MM TRYTON CORONARY STENT DELIVERY SYSTEM AT A BIFURCATION LESION IN THE CIRCUMFLEX ARTERY AND OBTUSE MARGINAL, AS THE PHYSICIAN WAS POSITIONING THE TRYTON STENT HE REALIZED HE HAD TO PULL BACK SOME. IN DOING SO, HE ENCOUNTERED SOME TORTUOSITY OF THE ARTERY AND DURING PULL BACK THE TRYTON STENT FELL OFF THE BALLOON. THE STENT FELL OFF IN THE ANATOMY AND THEY TRAPPED THE TRYTON WITH A DRUG ELUTING STENT AGAINST THE INTERIOR LUMEN. THERE WAS AN UNSPECIFIED PATIENT INJURY (NO FURTHER DETAILS WERE AVAILABLE). THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AFTER 3 1/2 DAYS. HE INITIALLY HAD AN IMPEL PUT IN AND WAS IN ICU. PER THE CLINICIAN'S FOLLOW UP, THE PATIENT IS NON-SYMPTOMATIC AND DOING QUITE WELL. WHAT WAS THE MEDINA CLASSIFICATION? 1,1,1. WHAT WAS PERCENT STENOSIS? 60%. WHAT WAS THE DEGREE OF CALCIFICATION? LOW. WHAT WAS THE DEGREE OF TORTUOSITY? HIGH. WAS THERE DIFFICULTY REACHING THE LESION? LESION - NONE. WAS THERE DIFFICULTY CROSSING THE LESION? NO. WERE MULTIPLE DILATATIONS PERFORMED DURING THE ATTEMPT TO PLACE THE TRYTON STENT? YES.

  Patient problems: Injury

  MAUDE report 7278558 ↗