Tryton Side Branch Stent T5-3035-151-USRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00894588002187), received between May 11, 2017 and Nov 9, 2018 — classified as 2 deaths, 5 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 9, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  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 STE

  Patient problems: Foreign Body In Patient

  MAUDE report 8056886 ↗
• DeathMay 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CASE WAS GOING SMOOTHLY UP UNTIL THE KISSING BALLOON TECHNIQUE. AFTER THIS WAS DONE, WE TOOK THE FINAL PICTURE AND FOUND A PERFORATION OF THE LAD. PERFORATION OCCURRED AT PROXIMAL PORTION OF THE TRYTON OR POTENTIALLY JUST PROXIMAL TO THE TRYTON. AT THIS TIME, THE PHYSICIAN COVERED WITH A COVERED STENT AND THE PATIENT WAS SENT TO RECOVERY. SHE WAS THE MONITORED FOR A FEW DAYS AND ALL SEEMED TO BE WELL. HOWEVER, ON THAT SUNDAY, SHE RESPIRATED AND PASSED AWAY. WHAT WAS THE TARGET LESION? LAD/DIAG. WHAT WAS THE MEDINA CLASSIFICATION? 1.1.1. WHAT WAS PERCENT STENOSIS? 65%. WAS THE DEVICE USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION > 3 MONTHS)? NO. 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? 7F. DID THE DEVICES 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. WAS

  Patient problems: Death; Vascular Dissection

  MAUDE report 7508705 ↗
• DeathApr 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A (B)(6) YEAR OLD PATIENT HAD UNDERGONE ELECTIVE PCI-STENT OF A COMPLEX LMCA LESION IN WHICH THE PATIENT RECEIVED A TRYTON STENT. INITIAL CASE WAS SIGNIFICANT FOR PLACEMENT OF TRYTON INTO THE LMCA WITH THE SIDE BRANCH PORTION INTO THE LCX AFTER WHICH A STANDARD DES WAS PLACED IN THE LMCA EXTENDING INTO THE LAD. TO ADDRESS ADDITIONAL DISEASE IN THE LCX A LONG DES WAS PLACED BRINGING IT BACK INTO THE LMCA UTILIZING 'TAP' TECHNIQUE AND FINISHING WITH A FINAL SIMULTANEOUS KISSING INFLATIONS WITH GOOD ANGIOGRAPHIC RESULT. THE PATIENT WAS DISCHARGED WITHOUT APPARENT COMPLICATIONS ON DAPT. MORE THAN 5 MONTHS LATER, THE PATIENT PRESENTED TO AN OUTSIDE HOSPITAL IN EXTREMIS. BRIEF ANGIOGRAPHY WAS PERFORMED WHICH DEMONSTRATED THROMBOTIC OCCLUSION OF THE LAD AND LCX. THE PATIENT WAS EMERGENTLY TRANSFERRED TO THE HOSPITAL AND PASSED SOON AFTER. ADDITIONAL DETAILS ON TRYTON STENT IMPLANTATION PROCEDURE: - CATH AT OUTSIDE HOSPITAL: 90% MEDINA 1,1,1 AT LEFT MAIN, HEAVILY CALCIFIED, WITH DISEASE EXTENDING INTO LARGE DISTAL LCX. RCA HAS DISEASE BUT IS NONDOMINANT. LVEF 40% ON CINEANGIOGRAPHY. - NINETY NINE DEGREE ANGLE BETWEEN LAD AND LCX. - TRYTON (3.0/3.5) PLACED AFTER POBA OF BOTH OSTIA. - POST D

  Patient problems: Death; Thrombosis

  MAUDE report 7445183 ↗
• MalfunctionJul 21, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  (B)(6) YO MALE PRESENTING TO THE REX ED WITH ANTERIOR STEMI. PATIENT GIVEN ASA AND A LOADING DOSE OF P2Y12 INHIBITOR AND HEPARIN AND BROUGHT EMERGENTLY TO THE CATH LAB. EN ROUTE OR ON ARRIVAL TO THE CATH LAB, THE PATIENT BECAME ELECTRICALLY UNSTABLE WITH MULTIPLE BOUTS OF VT-VF REQUIRING MULTIPLE SHOCKS (~ 10) AND AMIO LOAD AFTER WHICH STABILIZED. BASELINE ANGIO DEMONSTRATED 3 VD INCLUDING A PROXIMAL LAD (IRA) LONG TUBULAR AND LONG TUBULAR LESION IN MODERATE SIZE D2 (1.1.1). AFTER CONSULTATION WITH CARDIAC SURGERY, IT WAS DECIDED TO PROCEED WITH A PCI-STRATEGY. VIA A 6 FR (VIA A FEMORAL APPROACH) BOTH LAD AND DIAG WIRED. DIAG WAS PRE-DILATED WITH 2.5 BALLOON. INITIAL ATTEMPT TO DELIVER TRYTON SIDE BRANCH STENT WAS UNSUCCESSFUL. TRYTON WAS REMOVED, AFTER WHICH ADDITIONAL DILATION WAS PERFORMED. TRYTON WAS REINTRODUCED. ADDITIONAL ATTEMPT TO TRACK TRYTON ACROSS THE D2 LESION WAS UNSUCCESSFUL. TRYTON WAS THEN REMOVED. WHEN TRACKING A DILATION BALLOON ACROSS THE DIAG ORIGIN, DIFFICULTY WAS ENCOUNTERED. EXAMINATION OF THE TRYTON STENT DELIVERY BALLOON REVEALED ABSENCE OF THE STENT. EVALUATION OF THE FLUORO IMAGE IDENTIFIED THE TRYTON STENT IN THE LAD. INITIAL ATTEMPTS TO TRACK A DILATIO

  Patient problems: No Code Available

  MAUDE report 6731556 ↗
• MalfunctionJun 15, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ATTEMPTED TO DEPLOY TRYTON, FELT RESISTANCE WHEN TRYING TO GET IT TO COME OUT OF THE 6F GUIDE CATHETER. GUIDE CATHETER WAS A 6F MEDTRONIC LAUNCHER JL3.5 SHAPE. COULD NOT GET IT TO CROSS LESION, WHEN ATTEMPTING TO PULL BACK INTO GUIDE TO FURTHER PRE-DILATE TARGET LESION, THE TRYTON STENT CAME OFF OF THE BALLOON. THE TRYTON STENT WAS CRUSHED AGAINST PROFUNDA VESSEL WALL AND COVERED WITH ANOTHER STENT (INTERVENTION USING DK CRUSH TECHNIQUE). A SUBSEQUENT TRYTON STENT WAS NOT USED. PATIENT SURVIVED. NO DEATH. NO SERIOUS INJURY. TARGET LESION: CX/LM BIFURCATION. WAS A GUIDE LINER USED? NO. TYPE (SHAPE) OF GUIDE CATHETER WAS USED: MEDTRONIC LAUNCHER FL3.5. DEGREE OF CALCIFICATION: NONE. DEGREE OF TORTUOSITY: NONE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6645165 ↗
• MalfunctionMay 31, 2017Difficult to Advance; Difficult to Advance

  THE TRYTON STENT WAS PROPERLY PLACED AFTER A DISTAL STENT IN THE MAIN VESSEL (DISTAL PDA) WAS PLACED. VESSELS WERE WIRED AND PREDILATED. TRYTON WAS PLACED PROPERLY. WIRE PLACEMENT WAS LOST AND THE TWO PHYSICIANS WERE UNABLE TO REWIRE MAIN VESSEL. AFTER THREE HOURS IN THE CASE AND 300 CC OF CONTRAST, THE CASE WAS RESCHEDULED FOR DES PLACEMENT AT A LATER DATE. THE MAIN VESSEL DES WAS SUCCESSFULLY IMPLANTED IN THE PATIENT ON (B)(6) 2017 (NOTE: THE ORIGINAL PROCEDURE DATE WHEN THE TRYTON STENT WAS IMPLANTED WAS (B)(6) 2017). FINAL OUTCOME WAS GOOD/SUCCESSFUL. DEGREE OF TORTUOSITY: RCA WAS MODERATE TO SEVERE. ADDITIONAL DETAILS: TRYTON PASSED LESION EASY, DIFFICULTY PLACING DES. DISTANCE BETWEEN DISTAL STENT AND TRYTON: APPROXIMATELY 30 MM. THE DISTAL STENT DID NOT CONTRIBUTE TO INABILITY TO CONTINUE CASE. WHEN ATTEMPTING TO PLACE THE DES, THEY LOST WIRE PLACEMENT AND WERE UNABLE TO RE-WIRE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6600722 ↗
• MalfunctionMay 11, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE TRYTON SIDE BRANCH STENT DISLODGED FROM THE BALLOON UNDEPLOYED IN THE CORONARY ARTERY. THE PHYSICIAN PRE-DILATED WITH A 2.0 X 12 MM BALLOON ON THE DIAGONAL WIRE AND WAS UNABLE TO SUCCESSFULLY ADVANCE THE TRYTON STENT SYSTEM. THE STENT SYSTEM WAS THEN REMOVED AND A 2.5 X 12 MM NC BALLOON WAS USED TO PREDILATE THE LESION. A SECOND WIRE WAS THEN ADVANCED DOWN THE DIAGONAL TO HELP WITH TRACKING OF THE TRYTON SYSTEM AFTER THE NC BALLOON WAS REMOVED. AGAIN, TRYTON DID NOT TRACK DOWN THE VESSEL AND THE STENT SYSTEM WAS REMOVED. UPON REMOVAL, THE FELLOW NOTICED THAT THE TRYTON STENT WAS NOT ON THE BALLOON. UNDER FLUOROSCOPY, IT WAS DIFFICULT TO VISUALIZE THE UNDEPLOYED STENT. THE PHYSICIAN DECIDED TO ADVANCE A SMALL 1.5 MM BALLOON ON THE WIRE TO SEE IF IT WAS POSSIBLE TO CAPTURE THE STENT AND PULL IT BACK INTO THE GUIDE CATHETER. WHILE THIS ATTEMPT DID WORK IN CAPTURING THE STENT, THE STENT EDGE WAS CAUGHT ON THE GUIDING CATHETER AND IT COULD NOT BE RETRIEVED. A 2.5 MM BALLOON WAS ADVANCED, WHICH PUSHED THE STENT DOWN THE LAD/DIAGONAL WIRE AND THE STENT WAS DEPLOYED. THE PHYSICIAN THEN TOOK A DES AND DEPLOYED IT INSIDE THE TRYTON STENT WITHOUT COMPLICATION. IN THE END, THE OUTCOME WAS

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6561749 ↗