Tryton Side Branch Stent T5-2535-191-USRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00894588002149), received between Jun 15, 2017 and Sep 12, 2018 — classified as 1 injury, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NSTEMI/UNSTABLE ANGINA DUE TO RESTENOSIS OF A STENT PLACED DISTAL TO ORIGINAL TARGET LESION. THIS PARTICULAR STENT IS NOT PART OF THE TRYTON SIDE BRANCH STENT OR THE DES WITHIN THE TRYTON. THE STENT THAT RESTENOSED WAS A BAIL OUT STENT PLACED DURING INDEX PROCEDURE FAR DISTAL TO THE ORIGINAL LESION. THE BAILOUT STENT DURING THE INDEX PROCEDURE WAS DUE TO DISTAL DISSECTION INVOLVING THE MAIN BRANCH. LCX (CULPRIT VESSEL), 95% STENOSIS TREATED WITH ELUNIR STENT AND OM WITH 75% STENOSIS. PER PHYSICIAN, OM MAY HAVE HAD CONTRIBUTED TO THE EVENT BUT NOT THE CULPRIT VESSEL. AN INCIDENTAL FINDING WAS RESTENOSIS OF THE SIDE BRANCH PORTION OF THE TRYTON. A DECISION WAS MADE TO PLACE A SHORT DES IN THIS LOCATION. IT IS UNLIKELY THAT THIS CONTRIBUTED TO PRESENTATION OF NSTEMI. IN OTHER WORDS, THIS WAS A NON-CULPRIT SITE.

  Patient problems: Thrombosis

  MAUDE report 7870855 ↗
• MalfunctionJan 19, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  TRYTON STENT CAME OFF OF BALLOON, MIGRATING TO THE RIGHT PROFUNDA ARTERY WHEN ATTEMPTING TO RETRACT SDS IN THE AORTA DUE TO NO-CROSS. THE TRYTON WAS DISLODGED UPON CAREFUL RETRACTION INTO THE GUIDE CATHETER. THE BALLOON BECAME STUCK IN THE GUIDE ABOUT 90% RETRACTED INSIDE. AFTER TREATING THE LESION, THE TRYTON WAS ATTEMPTED TO BE RETRIEVED VIA A 4-8MM ENSNARE AND 6F SHEATH. THE STENT WAS SUCCESSFULLY SNARED, BUT UPON RETRACTION #1 INTO THE 6F SHEATH IT WOULDN'T PULL ALL THE WAY IN AND DISLODGED ONCE AGAIN INTO THE SAME ARTERY, THE RIGHT PROFUNDA. AN ADDITIONAL ATTEMPT USING A 6-10MM ENSNARE AND A 6F GUIDE CATHETER PROVED TO BE SUCCESSFUL IN RETRIEVING THE STENT INTACT). THE PATIENT WAS UNHARMED. NO ADDITIONAL TRYTON DEVICES WERE DEPLOYED. THE PATIENT'S OM1 WAS SUCCESSFULLY STENTED USING A 3.5 X 18MM XIENCE STENT IN A PROVISIONAL TECHNIQUE WITH EXCELLENT RESULT. POST RETRIEVAL, THE PATIENT WAS PLACED IN THE CATH LAB RECOVERY UNIT FOR STANDARD OBSERVATION, AND WAS DISCHARGED 2 DAYS LATER. THE DEVICE WAS POSSIBLY DAMAGED EITHER WHEN TRYING TO CROSS OR UPON RETRACTION. THE STENT HAD TO GO THROUGH AN ATHERECTOMIZED VESSEL, AS WELL AS 2 "STEP- LIKE" TURNS, HOWEVER ALL OTHER DEVICES EXCEP

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7207178 ↗
• MalfunctionJun 15, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE TRYTON SIDE BRANCH STENT CAME OFF OF THE BALLOON CATHETER WHILE ATTEMPTING TO REMOVE FROM THE PATIENT THROUGH GUIDE CATHETER. THE PHYSICIAN DID EXPERIENCE RESISTANCE WHEN TRYING TO CROSS THE LESION PRIOR TO PULLING THE TRYTON BACK TOWARDS THE GUIDE. ATTEMPT TO CROSS THE LESION WAS UNSUCCESSFUL AND UPON REMOVAL OF STENT DELIVERY SYSTEM, IT WAS NOTED THAT THE STENT WAS NO LONGER ON THE BALLOON. STENT WAS VISUALIZED UNDER FLOURO IN CIRCUMFLEX ARTERY. VESSEL WAS REWIRED AND A DES WAS ADVANCED TO SITE OF THE TRYTON STENT, INFLATED THUS CRUSHING THE TRYTON STENT INTO THE VESSEL WALL. NO ADVERSE PATIENT EVENT TOOK PLACE AND CASE WAS COMPLETED SUCCESSFULLY ONCE TRYTON STENT WAS CRUSHED. OTHER DETAILS: A GUIDELINER WAS NOT USED IN THIS PROCEDURE. THE TARGET VESSEL WAS CIRCUMFLEX, OM BIFURCATION. THIS WAS THE PHYSICIAN'S 7TH TRYTON CASE. DEGREE OF CALCIFICATION: HIGH. WAS THE DEVICE USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION > 3 MONTHS)? NO.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6645118 ↗