Tryton Side Branch Stent T5-2530-191-USRecalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00894588002132), received between Aug 7, 2017 and Jul 26, 2020 — classified as 1 death, 9 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (12 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 26, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE TRYTON STENT WAS ADVANCED WITH DIFFICULTY THROUGH A PROXIMAL STENOSIS, IT WAS UNABLE TO BE PASSED INTO THE OM FOR DEPLOYMENT. THE GUIDING CATHETER WAS MANIPULATED TO ENSURE A COAXIAL ORIENTATION. THE TRYTON WAS SLOWLY PULLED BACK TO THE GUIDING CATHETER AND BECAME DISLODGED FROM THE BALLOON. A SMALL DIAMETER BALLOON WAS PASSED OVER SB WIRE IN AN ATTEMPT TO CAPTURE THE STENT. THE GUIDING CATHETER AND ALL WIRES WERE REMOVED WITH THE BALLOON INFLATED IN ATTEMPT TO CAPTURE THE STENT. THE TRYTON STENT WAS JAILED IN PLACE BY ANOTHER STENT. THE DEVICE WAS PREPPED PER THE IFU. AN 8F MEDTRONIC EBU GUIDING CATHETER WAS USED. AT THE TIME OF THIS REPORT, NO ADVERSE OUTCOMES WERE NOTED AS A RESULT OF THE STENT COMING OFF THE DELIVERY BALLOON. WHAT WAS THE TARGET LESION (MV AND SB)? LEFT CX/OM. WHAT WAS THE MEDINA CLASSIFICATION? 1,1,1. WHAT WAS PERCENT MV AND SB STENOSIS? MV-70%, SB-70%. 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. DID THE DEVICE PREP NORMALLY (I.E. MAINTAIN NEGATIVE PRESSURE)? YES. WAS THERE ANY RESIST

  Patient problems: Foreign Body In Patient

  MAUDE report 10324413 ↗
• MalfunctionJul 26, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE TRYTON STENT WAS ADVANCED WITH DIFFICULTY THROUGH A PROXIMAL STENOSIS, IT WAS UNABLE TO BE PASSED INTO THE OM FOR DEPLOYMENT. THE GUIDING CATHETER WAS MANIPULATED TO ENSURE A COAXIAL ORIENTATION. THE TRYTON WAS SLOWLY PULLED BACK TO THE GUIDING CATHETER AND BECAME DISLODGED FROM THE BALLOON. A SMALL DIAMETER BALLOON WAS PASSED OVER SB WIRE IN AN ATTEMPT TO CAPTURE THE STENT. THE GUIDING CATHETER AND ALL WIRES WERE REMOVED WITH THE BALLOON INFLATED IN ATTEMPT TO CAPTURE THE STENT. THE TRYTON STENT WAS JAILED IN PLACE BY ANOTHER STENT. THE DEVICE WAS PREPPED PER THE IFU. AN 8F MEDTRONIC EBU GUIDING CATHETER WAS USED. AT THE TIME OF THIS REPORT, NO ADVERSE OUTCOMES WERE NOTED AS A RESULT OF THE STENT COMING OFF THE DELIVERY BALLOON. WHAT WAS THE TARGET LESION (MV AND SB)? LEFT CX/OM. WHAT WAS THE MEDINA CLASSIFICATION? 1,1,1. WHAT WAS PERCENT MV AND SB STENOSIS? MV-70%, SB-70%. 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. DID THE DEVICE PREP NORMALLY (I.E. MAINTAIN NEGATIVE PRESSURE)? YES. WAS THERE ANY RESIST

  Patient problems: Foreign Body In Patient

  MAUDE report 10324412 ↗
• InjuryApr 9, 2020Device Damaged by Another Device; Device Damaged by Another Device

  THE PHYSICIAN SUCCESSFULLY DEPLOYED THE 2.5/3.0MM X 19MM TRYTON CORONARY STENT & 3.0X20 MM ELUNIR STENTS INTO THE DIAGONAL (TRYTON) AND LAD (ELUNIR). THERE WAS NO REPORTED PATIENT INJURY. THE PHYSICIAN WAS IN THE PROCESS OF REPOSITIONING THE NON-CORDIS .014 WIRE, WHEN THE DISTAL END OF THE WIRE CAUGHT ONTO THE PROXIMAL STRUT OF THE STENT. THE PHYSICIAN TRIED TO REMOVE THE WIRE, BUT IT WOULDN'T COME LOOSE. THEY PROCEEDED TO USE A BALLOON AND DOTTER THE WIRE HOPING IT WOULD COME LOOSE, BUT THAT DIDN'T WORK. THEY THEN PROCEEDED TO USE A SNARE TO RETRIEVE THE WIRE, BUT THE SNARE BECAME STUCK. THEY PROCEEDED TO REMOVE THE GUIDE, SNARE, AND WIRE, AFTER THE SNARE BECAME CAUGHT. THERE WAS APPROXIMATELY 15MM OF THE WIRE STILL WRAPPED AROUND THE STRUT. THE PATIENT WAS STABLE THOUGH OUT THE PROCEDURE. THE PHYSICIAN THOUGHT IT WOULD BE BEST TO HAVE THE PATIENT UNDERGO A BYPASS (LIMA), BECAUSE THE WIRE WILL THROMBUS IN THE FUTURE. IT WAS REPORTED THAT THE PATIENT WAS STABLE AFTER THE SURGERY. THE TARGET LESION WAS LEFT ANTERIOR DESCENDING (LAD) AND SECOND DIAGONAL. THE MEDINA CLASSIFICATION WAS 1,1,1. THE PERCENT OF MV (MAIN VESSEL) AND SB (SIDE BRANCH) STENOSIS WAS 60-80%. THE DEVICE WAS NOT U

  Patient problems: No Code Available

  MAUDE report 9946880 ↗
• DeathFeb 5, 2020Device Damaged by Another Device; Device Damaged by Another Device

  THE PHYSICIAN SUCCESSFULLY DEPLOYED THE 2.5/3.0MM X 19MM TRYTON CORONARY STENT & 3.0X20 MM ELUNIR STENTS INTO THE DIAGONAL (TRYTON) AND LAD (ELUNIR). THERE WAS NO REPORTED PATIENT INJURY. THE PHYSICIAN WAS IN THE PROCESS OF REPOSITIONING THE NON-CORDIS .014 WIRE, WHEN THE DISTAL END OF THE WIRE CAUGHT ONTO THE PROXIMAL STRUT OF THE STENT. THE PHYSICIAN TRIED TO REMOVE THE WIRE, BUT IT WOULDN'T COME LOOSE. THEY PROCEEDED TO USE A BALLOON AND DOTTER THE WIRE HOPING IT WOULD COME LOOSE, BUT THAT DIDN'T WORK. THEY THEN PROCEEDED TO USE A SNARE TO RETRIEVE THE WIRE, BUT THE SNARE BECAME STUCK. THEY PROCEEDED TO REMOVE THE GUIDE, SNARE, AND WIRE, AFTER THE SNARE BECAME CAUGHT. THERE WAS APPROXIMATELY 15MM OF THE WIRE STILL WRAPPED AROUND THE STRUT. THE PATIENT WAS STABLE THOUGH OUT THE PROCEDURE. THE PHYSICIAN THOUGHT IT WOULD BE BEST TO HAVE THE PATIENT UNDERGO A BYPASS (LIMA), BECAUSE THE WIRE WILL THROMBUS IN THE FUTURE. IT WAS REPORTED THAT THE PATIENT WAS STABLE AFTER THE SURGERY. THE TARGET LESION WAS LEFT ANTERIOR DESCENDING (LAD) AND SECOND DIAGONAL. THE MEDINA CLASSIFICATION WAS 1,1,1. THE PERCENT OF MV (MAIN VESSEL) AND SB (SIDE BRANCH) STENOSIS WAS 60-80%. THE DEVICE WAS NOT U

  Patient problems: No Code Available

  MAUDE report 9670392 ↗
• MalfunctionSep 25, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE FOLLOWING ADDITIONAL DETAILS WERE RECEIVED REGARDING THIS STENT DISLODGEMENT EVENT. IN THE INITIAL PROCEDURE, THERE WAS RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE 6F VISTA BRITE TIP XB 3 GUIDE CATHETER. THIS GUIDE CATHETER IS NOT A TRYTON DEVICE; IT IS A CORDIS DEVICE AND CORDIS IS AWARE OF THE REPORTED ISSUE. THE GUIDE CATHETER KINKED JUST DISTAL TO THE END OF THE SHEATH. AT THE TIME OF THE INITIAL PROCEDURE, THE VASCULAR SURGEON DECIDED TO LEAVE THE DISLODGED STENT IN PLACE. SUBSEQUENTLY, THE PATIENT CAME BACK TO HAVE THE PCI COMPLETED AND THE PATIENT IS DOING WELL.

  Patient problems: Foreign Body In Patient

  MAUDE report 9115803 ↗
• MalfunctionJul 16, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE TRYTON STENT CAME OFF THE BALLOON IN THE PATIENT. NO ATTEMPT TO RETRIEVE IT [THE STENT]. HE [DOCTOR] CRUSHED IT AGAINST THE WALL OF THE LAD. THE PATIENT WAS NOT INJURED. WHAT WAS THE TARGET LESION (MV AND SB)? LAD/DIA. WHAT WAS PERCENT MV AND SB STENOSIS? 90%. 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? XB 3.5. 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. WAS THERE DIFFICULTY REACHING THE LESION? YES, [THEY] COULD NOT CROSS WITH TRYTON. WAS THERE DIFFICULTY CROSSING THE LESION? YES, [THEY] COULD NOT CROSS THE LESION WITH TRYTON. WERE MULTIPLE DILATATIONS PERFORMED DURING THE ATTEMPT TO PLACE THE TRYTON STENT? TWICE. WAS THE TRYTON STENT REMOVED BETWEEN DILATATIONS? IF SO, HOW MANY TIMES WAS IT REMOVED AND WAS IT CHECKED VISUALLY FOR DISTORTION/DA

  Patient problems: Foreign Body In Patient

  MAUDE report 8796723 ↗
• InjuryJul 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CONTINUATION OF THE LCX CLOSED AFTER DEPLOYMENT OF THE TRYTON STENT FROM PROXIMAL LCX INTO OM1 AND DILATION WITH A SHORT 4.0MM BALLOON IN THE PROXIMAL PORTION. THE PATIENT EXPERIENCED SIGNIFICANT CHEST PAIN BUT REMAINED STABLE FROM RHYTHM AND HEMODYNAMIC STANDPOINTS. MULTIPLE WIRES WERE USED TO REACCESS THE AND EVENTUALLY OPEN THE LCX CONTINUATION. THE ONYX STENT WAS THEN DEPLOYED FROM PROXIMAL TO MID LCX. A SIDE CELL OF THE STENT WAS BALLOONED TO "UNJAIL" THE OM1 WITH KISSING BALLOON INFLATION. A GOOD ANGIOGRAPHIC RESULT WAS ACHIEVED. CK-MB [OF 51.7 IS] GREATER THAN 3X THE UPPER NORMAL LIMIT [OF 7.2]. THIS IS DEFINED AS A PERI-PROCEDURAL MI. WHAT WAS THE TARGET LESION (MV AND SB)? MV - 18.5-MID CIRC NO 5, SB - 20-1ST OB MARG. WHAT WAS THE MEDINA CLASSIFICATION? 1.1.1. WHAT WAS PERCENT STENOSIS? MV - 80%, SB - 80%. WAS THE DEVICE USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION > 3 MONTHS)? NO. WHAT WAS THE DEGREE OF CALCIFICATION (NONE/LOW/MEDIUM/HIGH)? NONE. WHAT WAS THE DEGREE OF TORTUOSITY (NONE/LOW/MEDIUM/HIGH)? LOW. WHAT GUIDE CATHETER (SIZE AND TYPE) WAS USED? 6FR EBU 4. DID THE DEVICE PREP NORMALLY (I.E. MAINTAIN NEGATIVE PRESSURE)? YES. WAS THERE ANY RESISTANCE/FRIC

  Patient problems: Myocardial Infarction

  MAUDE report 8787568 ↗
• MalfunctionJul 8, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO TREAT THE LAD/3RD DIAGONAL LESION USING TWO TRYTON STENTS. THE FIRST TRYTON STENT (2.5X3.0) WAS UNABLE TO CROSS THE LESION DUE TO, WHAT WAS LATER DETERMINED TO BE, INTERFERENCE FROM A STENT THAT HAD BEEN PREVIOUSLY IMPLANTED AT THE 2ND DIAGONAL AND WHICH HAD LIFTED STRUTS. THE FIRST TRYTON WAS SUCCESSFULLY WITHDRAWN WITHOUT BEING EXPANDED. THE 3RD DIAGONAL LESION WAS DILATED AGAIN. THIS WAS FOLLOWED WITH ATTEMPTING TO TREAT THE LESION WITH A SECOND TRYTON DEVICE (2.5X2.5). THE SECOND TRYTON DEVICE WAS ALSO UNABLE TO CROSS THE LESION. WHEN TRYING TO WITHDRAW THE SECOND TRYTON DEVICE, IT BECAME DISLODGED AND CAME TO REST IN THE RIGHT COMMON FEMORAL ARTERY. LEFT FEMORAL ACCESS WAS OBTAINED AND THE STENT WAS RETRIEVED USING A SNARE. THE REMOVED SECOND TRYTON DEVICE WAS EXAMINED AND FOUND TO HAVE ATTACHED TO IT THE PREVIOUSLY IMPLANTED 2ND DIAGONAL STENT. THE FOLLOWING ANGIOGRAM SHOWED A DISSECTION IN THE LAD WHICH WAS SUBSEQUENTLY TREATED WITH STENTING.

  Patient problems: Foreign Body In Patient; Vascular Dissection

  MAUDE report 8770092 ↗
• MalfunctionMay 2, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  UPON ATTEMPTING TO INSERT THE [TRYTON] STENT IT BECAME DISLODGED FROM THE BALLOON AND SETTLED INTO THE PATIENT'S RIGHT CORONARY ARTERY. ATTEMPTS WERE MADE TO SNARE THE STENT BUT WERE UNSUCCESSFUL SO THE PHYSICIAN CRUSHED IT WITH ANOTHER STENT. THERE WAS NO PATIENT INJURY. WHAT WAS THE TARGET LESION (MV AND SB)? RCA AND PLV [POSTERIOR LEFT VENTRICULAR ARTERY] WHAT WAS THE MEDINA CLASSIFICATION? 1,1,1. WHAT WAS PERCENT MV AND SB STENOSIS? MB 100% CTO, SB 60%. WAS THE DEVICE USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION > 3 MONTHS)? MAIN BRANCH CTO. SB NO CTO. 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? 6F EBU. 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? YES, ONCE THE STENT EXITED THE GUIDE THERE WAS RESISTANCE AT THE RCA OSTIUM. WAS PREDILATATION PERFORMED PRIOR TO ATTEMPTING TO PLACE THE TRYTON STENT? YES . WAS THERE DIFFICULT

  Patient problems: Foreign Body In Patient

  MAUDE report 8575096 ↗
• InjuryApr 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED WITH CHEST PAIN THE MORNING OF (B)(6) 2019. IT WAS REPORTED THAT THE SIDE BRANCH (1ST DIAG) HAD 90% IN-STENT RESTENOSIS. RESOLVED AFTER DES PLACEMENT AT DISTAL EDGE OF PREVIOUSLY PLACED STENT AND IN THE PROXIMAL/OSTIAL 1ST DIAGONAL. A 2.0 X 8 ONYX STENT AND A 2.0 X 12 ONYX STENT WERE USED TO TREAT THE LESIONS. AFTER PCI, 1ST DIAGONAL SHOWED 0% STENOSIS. PATIENT EXPERIENCED BRADYCARDIA AND WAS HYPOTENSIVE AFTER PCI AND TRANSFERRED TO ICU. PATIENT RECOVERED AND WAS DISCHARGED ON (B)(6) 2019. ADDITIONAL NOTES: ON (B)(6) 2018: TRYTON WAS INITIALLY IMPLANTED IN LAD/DIAG AND XIENCE STENT IN MV. ON (B)(6) 2018: PATIENT WAS TREATED FOR RESTENOSIS 237 DAYS POST INDEX PROCEDURE. IT WAS REPORTED THAT THE SIDE BRANCH HAD 70-80% IN-STENT RESTENOSIS IN THE DIAGONAL. THE DECISION WAS MADE TO TREAT THE RESTENOSIS MEDICALLY. NO CHANGES IN MEDICATION WERE NOTED. REFERENCE MANUFACTURER REPORT NO. 3007210870-2018-00014.

  Patient problems: No Code Available

  MAUDE report 8533145 ↗
• InjuryApr 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A SEPTAL BRANCH DISTALLY TO THE BIFURCATION. THE SEPTAL BRANCH BECAME OCCLUDED DURING THE PROCEDURE AND WAS JAILED OFF DUE TO THE MAIN BRANCH STENT. THE PATIENT STATED SHE HAD CHEST PAIN THAT LASTED LESS THAN 1 MINUTE DURING THE PROCEDURE. THE TRYTON STENT WAS A SUCCESS AND THE PATIENT LEFT THE CATH LAB FOR POST-OP RECOVERY. THE PHYSICIAN FELT IT WAS BEST TO ADMIT THE PATIENT FOR OBSERVATION. THE PATIENT WAS DOING WELL AND DISCHARGED ON (B)(6) 2019. THEY'RE CALLING IT A NSTEMI TYPE 4A. WHAT WAS THE TARGET LESION (MV AND SB)? MV - LAD, SB - DIAG. WHAT WAS THE MEDINA CLASSIFICATION? 1.1.1. WHAT WAS PERCENT STENOSIS? MV - 90%, SB - 90%. WAS THE DEVICE USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION > 3 MONTHS)? NO. WHAT WAS THE DEGREE OF CALCIFICATION (NONE/LOW/MEDIUM/HIGH)? NONE TO LOW. WHAT WAS THE DEGREE OF TORTUOSITY (NONE/LOW/MEDIUM/HIGH)? NONE. WHAT GUIDE CATHETER (SIZE AND TYPE) WAS USED? 6 FR - BOSTON SCIENTIFIC RUNWAY VL3 GUIDE CATHETER. 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 INSERTIN

  Patient problems: Myocardial Infarction

  MAUDE report 8470809 ↗
• MalfunctionNov 27, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A TRYTON STENT DISLODGEMENT OCCURED. THEIR INTENTION WAS TO PLACE THE TRYTON IN THE DIAG, AND A DES IN THE LAD. THEY LOADED THE TRYTON STENT ON THE LAD WIRE, WHEN THEY REALIZED IT, HE WITHDREW THE STENT BACK TO THE GUIDE, HOWEVER THE TRYTON STENT CAME OFF THE BALLOON. HE TRIED A FEW THINGS TO RETRIEVE THE STENT UNSUCCESSFULLY SO ENDED UP DEPLOYING IT IN THE LEFT MAIN/LAD. THEY COMPLETED THE CASE BY DOING A T STENT PROCEDURE WITH TWO ONYX DES'S. THE RESULT WAS GOOD (FOR A T STENT TECHNIQUE), THERE WAS NO HARM OR INJURY TO THE PATIENT. AFTER THE CASE, [THE PHYSICIAN] ACKNOWLEDGED THAT HE KNEW NOT TO PULL THE TRYTON STENT BACK INTO THE GUIDE. WHAT WAS THE MEDINA CLASSIFICATION? 1,1,1. WHAT WAS PERCENT STENOSIS? 50% DIAG, 85% LAD. 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)? LOW. WHAT GUIDE CATHETER (SIZE AND TYPE) WAS USED? 6F, SHAPE NOT KNOWN. 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 TH

  Patient problems: Foreign Body In Patient

  MAUDE report 8108206 ↗
• MalfunctionNov 9, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PHYSICIAN WAS PERFORMING A TRYTON PROCEDURE WHEN THE STENT CAME OFF OF THE BALLOON IN THE LM. THE TRYTON STENT WAS ACROSS THE LESION WITH NO ISSUES. THE PATIENT [TOOK] A LARGE BREATH PULLING BACK THE GUIDE, WIRES AND TRYTON. THE PHYSICIAN PULLED THE TRYTON BACK IN THE GUIDE TO REWIRE AND THAT IS WHEN IT WHEN IT WAS DISCOVERED THAT THE STENT HAD BEEN DISLODGED FROM THE BALLOON. THE PHYSICIAN WAS ABLE TO SNARE THE DISLODGED STENT AND REMOVE IT THROUGH THE RADIAL ARTERY. A NEW TRYTON STENT WAS USED TO COMPLETE THE PROCEDURE. WHAT WAS THE TARGET LESION (MV AND SB)? CIRC AND OM3. 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. 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? EBU 4 6 FR. DID THE DEVICE PREP NORMALLY (I.E. MAINTAIN NEGATIVE PRESSURE)? WAS NOT PREPPED YET. FOLLOW-UP RESPONSE FROM THE SALES REP: THE DEVICE WAS NOT PREPPED AT ALL IN OR OUT OF THE BODY PRIOR TO COMING OFF THE BALLOON. WAS THERE ANY RESISTANCE/FRICTION WHILE INSERTING

  Patient problems: Foreign Body In Patient

  MAUDE report 8056905 ↗
• InjuryOct 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED WITH UNSTABLE ANGINA. CATHETERIZATION SHOWED 70-80% IN-STENT RESTENOSIS IN THE DIAG. DIAG WAS A SMALL VESSEL WHICH WAS DECIDED TO TREAT MEDICALLY. RELATION TO TRYTON DEVICE WAS DESCRIBED BY INVESTIGATOR AS "HIGHLY PROBABLE." PATIENT OUTCOME WAS RECOVERED/RESOLVED WITH SEQUELAE. WHAT WAS THE TARGET LESION (MV AND SB)? MV - 13-MID LAD, SB - 15-1ST DIAG. WHAT WAS THE MEDINA CLASSIFICATION? 0,1,1. WHAT WAS PERCENT STENOSIS? MV - 90%, SB - 80%. WAS THE DEVICE USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION > 3 MONTHS)? NO. WHAT WAS THE DEGREE OF CALCIFICATION (NONE/LOW/MEDIUM/HIGH)? NONE. WHAT WAS THE DEGREE OF TORTUOSITY (NONE/LOW/MEDIUM/HIGH)? NONE. WHAT GUIDE CATHETER (SIZE AND TYPE) WAS USED? 6F FORTE. 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? NONE. WAS THERE ANY RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER? NONE. WAS PREDILATATION PERFORMED PRIOR TO ATTEMPTING TO PLACE THE TRYTON STENT? YES. WAS THERE DIFFICULTY REACHING THE LESION? NO. WAS THERE DIFFICULTY CROSSING THE LESION? NO. WERE MULTIPLE DILATATIO

  Patient problems: No Code Available

  MAUDE report 7957965 ↗
• InjuryAug 15, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  POST PROCEDURE, THE PATIENT REPORTED CHEST PAIN AND WAS TESTED TO HAVE ELEVATED CARDIAC ENZYME BIOMARKERS (TROPONIN, CK, AND CKMB). THIS PATIENT ALSO HAD A DISSECTION (DISTAL TRYTON STENT EDGE OF DIAGONAL) DURING THE PROCEDURE. AS A RESULT, AN ADDITIONAL STENT WAS PLACED TO COVER THIS LESION. THE DOCTOR ALSO NOTED THAT THE MB DISEASE APPEARED TO BE APPROXIMATELY 30 MM. TWO SEPARATE STENTS WERE PLACED THEREAFTER IN THE MB TO TREAT THIS DISEASE. THE FINAL PATIENT OUTCOME WAS RECOVERED/RESOLVED. WHAT WAS THE TARGET LESION? MID-LAD / 1ST DIAG. WHAT WAS THE MEDINA CLASSIFICATION? 1.1.1. WHAT WAS PERCENT STENOSIS? 90% LAD, 60% DIAGONAL. WAS THE DEVICE USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION > 3 MONTHS)? NO. WHAT WAS THE DEGREE OF CALCIFICATION (NONE/LOW/MEDIUM/HIGH)? LOW. WHAT WAS THE DEGREE OF TORTUOSITY (NONE/LOW/MEDIUM/HIGH)? NONE. WHAT WAS THE ANGLE OF THE BIFURCATION? 45. WHAT GUIDE CATHETER (SIZE AND TYPE) WAS USED? 7FR XB GUIDECATH. 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 THRO

  Patient problems: Myocardial Infarction; Vascular Dissection

  MAUDE report 7787226 ↗
• MalfunctionMay 17, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DIFFICULT, TORTUOUS, CALCIFIED LESION. THE TARGET LESION WAS CX/MARGINAL. STENT INSERTED, DUE TO CALCIFICATION, UNABLE TO DELIVER TO THE ANTICIPATED SITE. REMOVAL OF STENT DELIVERY SYSTEM AND STENT WAS NOT ON THE BALLOON. STENT HAD STRIPPED OFF OF THE BALLOON SHAFT. FULL FLUORO/CINE AFTER THE INCIDENT. UNABLE TO FIND THE STENT AFTER IT STRIPPED OFF. NO INJURY TO PATIENT. 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. WHAT WAS THE DEGREE OF CALCIFICATION (NONE/LOW/MEDIUM/HIGH)? HIGH. WHAT WAS THE DEGREE OF TORTUOSITY (NONE/LOW/MEDIUM/HIGH)? MEDIUM. WHAT GUIDE CATHETER (SIZE AND TYPE) WAS USED? BELIEVED TO BE AN EBU. DID THE DEVICE PREP NORMALLY (I.E. MAINTAIN NEGATIVE PRESSURE)? PREPPED NORMALLY. 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? NO. WAS THERE DIFFICULTY REACHING THE LESION? YES. WAS THERE DIFFICULTY CROSSING THE LESION? YES. WERE MULT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7521686 ↗
• MalfunctionMay 2, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  WHILE ATTEMPTING TO DELIVER A 2.5 X 3.0 MM TRYTON STENT FROM A RADIAL APPROACH (USING A 6 FRENCH GUIDING CATHETER) TO AN LAD/CIRC STENOSIS, THE STENT CAME OFF THE BALLOON. THE GUIDE CATHETER WAS NOT PROPERLY SEATED AT THE OSTIUM OF THE LEFT MAIN AND DID NOT PROVIDE ADEQUATE SUPPORT DURING TRACKING OF THE TRYTON STENT (THE CATHETER WAS NOT ENGAGED WITH THE LEFT MAIN). SUBSEQUENTLY, WHILE TRACKING THE TRYTON STENT DELIVERY SYSTEM, THE STENT EXITED THE GUIDE WITHIN THE AORTA AND COULD NOT ADVANCE WITHIN THE LEFT MAIN DUE TO THE LACK OF GUIDE SUPPORT. WHILE ATTEMPTING THE WITHDRAW THE TRYTON, THE STENT BECAME DISLODGED. THE TRYTON STENT WAS FOUND IN THE RIGHT PROFUNDA AND SUCCESSFULLY SNARED AND REMOVED. USING THE SAME GUIDING CATHETER, AND FEMORAL ACCESS, THE PHYSICIAN WAS ABLE TO SUCCESSFULLY IMPLANT A NEW TRYTON STENT WITHIN THE TARGET LESION WITHOUT DIFFICULTY. THE PHYSICIAN NOTED THAT THE GUIDING CATHETER SHAPE WAS DESIGNED FOR FEMORAL ACCESS AND AS A RESULT, IT WAS APPROPRIATELY ENGAGED WITHIN THE LEFT MAIN. THE CASE WAS PART OF THE TRYTON POST-APPROVAL STUDY. THERE WAS NO PATIENT INJURY. WHAT WAS THE MEDINA CLASSIFICATION? 1-1-1. WHAT WAS PERCENT STENOSIS? 70% - 80%. WAS THE DEV

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7479383 ↗
• MalfunctionApr 13, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  TRYTON STENT CAME OFF BALLOON PRIOR TO DEPLOYMENT INSIDE THE PATIENT. TRYTON WAS ABLE TO BE RETRIEVED FROM THE LEFT MAIN CORONARY ARTERY BUT IT DOES REMAIN IN THE PATIENT'S PROFUNDA FEMORIS ARTERY. THE DOCTOR USED ANOTHER TRYTON (2.5 X 3.0) ON THIS SAME PATIENT AND HAD NO ISSUES WITH EXCELLENT END RESULT. THE DOCTOR STATED THAT THE PATIENT IS DOING FINE. WHAT WAS THE TARGET LESION? LAD/DIAG. WHAT WAS PERCENT STENOSIS? 90. 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)? HIGH . WHAT GUIDE CATHETER (SIZE AND TYPE) WAS USED? 7FR. DID THE DEVICE PREP NORMALLY (I.E. MAINTAIN NEGATIVE PRESSURE)? SCRUB ASPIRATED PRIOR TO CROSSING LESION. 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 THERE DIFFICULTY REACHING THE LESION? YES. WAS THERE DIFFICULTY CROSSING THE LESION? YES . WERE MULTIPLE DILATATIO

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7430318 ↗
• InjuryApr 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CASE WAS DONE SUCCESSFULLY; HOWEVER, WHEN PHYSICIAN ATTEMPTED TO REWIRE THE SIDE BRANCH TO END WITH A KISS, HE HAD TROUBLE RE-WIRING AND DECIDED TO BE DONE. HE WAS PLEASED WITH THE ANGIOGRAPHIC RESULTS. HE DOES ADMIT AFTER THE FACT THAT HE SHOULD HAVE GIVEN MORE EFFORT TO KISS. PATIENT WAS THIN, SO SHEATH WAS LEFT IN PLACE. THE PATIENT THEN HAD CHEST PAIN AND ABNORMAL EKG, LESS THAN AN HOUR AFTER THE PROCEDURE. THE PHYSICIAN REQUESTED THAT THE PATIENT BE PUT BACK ON THE TABLE. WHEN HE TOOK PICTURES, THERE WAS CLEARLY SOME THROMBUS OR STENOSIS IN THE SIDE BRANCH WITHIN THE TRYTON STENT. FLOW WAS STILL GOOD AND BRISK, BUT HE BALLOONED THE SIDE BRANCH AND HELD IT UP FOR A FEW MINUTES. AFTER THAT, IT LOOKED GREAT SO THAT WAS ALL THAT WAS DONE. THE PHYSICIAN SAID LATER THAT AFTERNOON THAT THE PATIENT WAS DOING WELL, NO PAIN. THE PHYSICIAN LATER REMARKED THAT HER "LV TOOK A HIT." WHAT WAS THE TARGET LESION? CX, OM WAS THE DEVICE USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION > 3 MONTHS)? NO WHAT WAS THE DEGREE OF CALCIFICATION (NONE/LOW/MEDIUM/HIGH)? NO WHAT WAS THE DEGREE OF TORTUOSITY (NONE/LOW/MEDIUM/HIGH)? LOW WHAT GUIDE CATHETER (SIZE AND TYPE) WAS USED? 6F, CATHETER SHAPE NOT

  Patient problems: Thrombosis

  MAUDE report 7404056 ↗
• MalfunctionJan 19, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE STENT SEPARATED FROM THE BALLOON IN THE PATIENT'S VASCULATURE. THE PHYSICIAN NOTED THAT SEPARATION OCCURRED AFTER DELIVERING IN A TORTUOUS CIRCUMFLEX ARTERY. THERE WAS NO INJURY TO PATIENT, AND DEVICE WAS SNARED OUT THROUGH FEMORAL ARTERIAL SHEATH. NO SUBSEQUENT TRYTON STENT WAS USED IN THIS CASE. WHAT WAS THE TARGET LESION? CIRCUMFLEX. WAS THERE DIFFICULTY REACHING THE LESION? YES - VERY TORTUROUS. WAS THERE DIFFICULTY CROSSING THE LESION? YES. 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.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7207143 ↗
• InjuryOct 23, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INDEX PROCEDURE (B)(6) 2017: 2 PROWATER 0.014" WIRES INTRODUCED ONE IN THE SB (DIAG) AND ONE IN THE MAIN BRANCH (LAD). PRE-DILATATION OF THE SIDE BRANCH PERFORMED WITH A 2.5 X 12 EMERGE BALLOON WITHOUT DIFFICULTY. TRYTON 2.5 BY 3.0 STENT DEPLOYED IN SB AND MB. POT PERFORMED WITH A 3.0 X 12 NC TREK BALLOON, RELOCATED POT BALLOON TO THE PROXIMAL TRYTON AND ATTEMPTED TO WIRE THE MB WITH THE SB PROWATER GW. HAD SOME DIFFICULTY WIRING THE MB WITH THE PROWATER AND SWITCHED TO A PT GRAPHIX GW WHICH MANEUVERED INTO THE MB WITHOUT DIFFICULTY. THE 3.0 X 12 NC TREK WAS THEN POSITIONED IN THE MB TROUGH [THROUGH] THE TRYTON WITHOUT DIFFICULTY AND A PRE-DILATATION WAS PERFORMED ON THE MB. THE POT BALLOON WAS REMOVED AND A 3.0 X 28 XIENCE DES WAS POSITIONED IN THE MB ONCE SATISFIED WITH THE DES POSITIONING THE MB PROWATER WAS WITHDRAWN TO THE PROXIMAL VESSEL AND THE XIENCE WAS DEPLOYED. THE DES DELIVERY SYSTEM WAS REMOVED AND THE SB WAS ATTEMPTED TO BE REWIRED WITH THE PARKED PROWATER GW, HAD SOME DIFFICULTY REWIRING THE SB AND SWITCHED TO A PT GRAPHIX GW. ANGIOGRAMS OF THE TRYTON AND XIENCE SHOWED WIDE OPEN STENTED AREA BUT WITH DISTAL DISEASE IN BOTH VESSELS. A 2.5 X 12 NC TREK AND A 3.0 X 12 N

  Patient problems: Myocardial Infarction; Thrombosis

  MAUDE report 6970222 ↗
• InjuryAug 7, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A TRYTON STENT PLACED ON (B)(6). THE PATIENT WAS BROUGHT BACK EMERGENTLY TO THE CCL ON (B)(6) AND THOSE ARTERIES STENTED WERE BALLOONED OPEN. AN OCT IMAGING RUN WAS PERFORMED AT THAT TIME. THE PATIENT WAS BROUGHT BACK A SECOND TIME, ALSO EMERGENTLY, ON (B)(6). BALLOONING WAS PERFORMED AT THAT TIME AS WELL. THE PATIENT WAS DISCHARGED ON (B)(6). THE PATIENT'S ISSUE WAS RESOLVED BY ADDRESSING THE VESSEL OCCLUSION DUE TO THROMBOSIS. PTCA WAS USED TO OPEN OCCLUDED VESSELS. THE OCT SHOWED CALCIFICATION IN THE MAIN BRANCH DISTAL TO THE BIFURCATION. PHYSICIAN SUPPOSED IT WAS NOT POST DILATED ENOUGH THUS CAUSING THE THROMBOSIS. THIS PATIENT HAS A HISTORY OF STENT THROMBOSIS IN OTHER VESSELS, DURING A PRIOR CORONARY INTERVENTION.

  Patient problems: Thrombosis

  MAUDE report 6772221 ↗