TriClip™ TCDS0301-XTWRecalls & reported problems

Summary

The FDA's MAUDE database contains 287 adverse event reports that list this exact device (DI 05415067047755), received between May 7, 2024 and Sep 9, 2026 — classified as 2 deaths, 184 injuries, 101 malfunctions.

The most frequently reported specific device problem is “Incomplete Coaptation” (144 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 25 most recent of 287 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2026Migration

  It was reported on (b)(6)2025 that the patient presented with grade 5 functional tricuspid regurgitation (TR) for a TriClip procedure. During the procedure, 2 TriClips were implanted. The TR was reduced to grade 2 post procedure.On an unknown day in (b)(6) 2026, patient returned symptomatic with recurrent TR of grade 4 and fatigue was noted. The second TriClip XTW was observed to be tilted and partially detached from posterior leaflet in transesophageal echocardiogram (TEE). There was no clinically significant delay reported.

  Patient problems: Fatigue; Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 50694686 ↗
• InjuryJun 18, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A TRICLIP PROCEDURE WAS PERFORMED TO TREAT FUNCTIONAL TRICUSPID REGURGITATION (TR) WITH A GRADE OF 5 ON A PATIENT WITH A RESTRICTED ANTERIOR AND POSTERIOR LEAFLET. A TRICLIP XTW WAS INSERTED. HOWEVER, WHILE CROSSING THE SEPTAL AND ANTERIOR LEAFLETS, THE PATIENT WENT INTO A LEFT BUNDLE BRANCH BLOCK (HEART BLOCK). TO TREAT THE HEART BLOCK, A TEMPORARY PACEMAKER WAS PLACED. THE PROCEDURE WAS COMPLETED WITH TWO CLIPS IMPLANTED, REDUCING TR TO A GRADE OF 1-2. IN THE PHYSICIAN'S OPINION, THE CLIP CONTRIBUTED TO THE PATIENT'S LEFT BUNDLE BRANCH (HEART BLOCK), REQUIRING A TEMPORARY PACEMAKER. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 25555513 ↗
• MalfunctionMay 21, 2026Improper or Incorrect Procedure or Method; Unintended Movement

  IT WAS REPORTED ON (B)(6) 2026 THAT THE PATIENT PRESENTED WITH GRADE 5+ FUNCTIONAL TRICUSPID REGURGITATION (TR) FOR A TRICLIP PROCEDURE. DURING THE PROCEDURE, THE CLIP DELIVERY SYSTEM HANDLE WAS CURVED MORE THAN 90 DEGREES. A TRICLIP WAS SUCCESSFULLY IMPLANTED. AFTER 30 MINUTES POST DEPLOYMENT, THE CLIP OPENED UP 20 DEGREES. THE TR REMAINED UNCHANGED POST PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY REPORTED.

  Patient problems: Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 25242727 ↗
• InjuryApr 30, 2026Incomplete Coaptation

  IT WAS REPORTED ON (B)(6) 2026 THAT THE PATIENT PRESENTED WITH GRADE 5 FUNCTIONAL TRICUSPID REGURGITATION (TR) AND RESTRICTED SEPTAL LEAFLET FOR A TRICLIP PROCEDURE. DURING THE PROCEDURE, IMAGING WAS DIFFICULT. 3 TRICLIPS WERE SUCCESSFULLY IMPLANTED. POST DEPLOYMENT, SECOND TRICLIP HAD SINGLE LEAFLET DEVICE ATTACHMENT(SLDA) FROM THE SEPTAL LEAFLET. ADDITIONAL CLIP WAS DEPLOYED TO STABILIZE THE SLDA CLIP. THE TR WAS REDUCED TO GRADE 2-3 POST PROCEDURE. ON (B)(6) 2026, THIRD TRICLIP ALSO HAD SLDA FROM THE POSTERIOR LEAFLET. RECURRENT MR OF GRADE 5+ WAS REPORTED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25046374 ↗
• InjuryApr 23, 2026Migration

  IT WAS REPORTED THAT A TRICLIP PROCEDURE WAS PERFORMED TO TREAT FUNCTIONAL TRICUSPID REGURGITATION (TR) WITH A GRADE OF 4-5 ON A PATIENT WITH A RESTRICTED SEPTAL LEAFLET AND PREVIOUSLY PLACED PACEMAKER LEAD. A TRICLIP XTW WAS INSERTED AND DEPLOYED ON THE TRICUSPID VALVE. HOWEVER, DIFFICULTIES VISUALIZING THE CLIP OCCURRED, AND POST DEPLOYMENT, THE CLIP PARTIALLY DETACHED FROM THE SEPTAL LEAFLET AND REMAINED FULLY ATTACHED TO THE OTHER LEAFLET (PARTIAL CLIP MOVEMENT). TO STABILIZE THE CLIP A SECOND CLIP WAS INSERTED AND GRASPING WAS PERFORMED. HOWEVER, THE LEAFLETS WERE UNABLE TO GRASPED. THEREFORE, THE CLIP WAS REMOVED FROM THE PATIENT. NO ADDITIONAL CLIPS WERE IMPLANTED, AND THE TR REMAINED AT A GRADE OF 4-5. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 24972044 ↗
• InjuryMar 30, 2026Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2025, A PATIENT PRESENTED WITH GRADE 4 FUNCTIONAL TRICUSPID REGURGITATION (TR) FOR A TRICLIP PROCEDURE. DURING THE PROCEDURE, TWO TRICLIPS WERE IMPLANTED SUCCESSFULLY. IMAGING WAS DIFFICULT. THE FINAL TR WAS GRADE 1. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED. ON (B)(6) 2025 FOLLOW UP, IT WAS DETERMINED THAT A SINGLE LEAFLET DEVICE ATTACHMENT HAS OCCURRED FOR THE SECOND CLIP AND CLIP WAS NO LONGER ATTACHED TO THE ANTERIOR LEAFLET. PER THE PHYSICIAN, SLDA WAS DUE TO THE PRE-EXISTING PATIENT ANATOMY. TR WAS GRADE 2 AFTER SLDA.

  Patient problems: Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 24717916 ↗
• InjuryFeb 16, 2026Positioning Failure; Premature Activation; Difficult to Remove; Difficult to Open or Close

  SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, THE FOLLOWING INFORMATION WAS CORRECTED: THE CORRECT LOT NUMBER FOR THE SECOND CLIP HAS BEEN CORRECTED TO 50827R1034), AS THE CLIP 50821R1018 WAS THE FIRST CLIP IMPLANTED AND IMPLANTED WITH SUCCESS.

  Patient problems: Embolism/Embolus

  MAUDE report 24351417 ↗
• InjuryFeb 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT PRESENTED WITH FUNCTIONAL TRICUSPID REGURGITATION (TR) AND CENTRAL JET WITH PREVIOUS TRICUSPID AORTIC VALVE REPLACEMENT (TAVR) FOR A TRICLIP PROCEDURE. PATIENT PRE-PROCEDURE GRADIENT WAS 1MMHG. DURING THE PROCEDURE, ONE TRICLIP XTW WAS IMPLANTED ON MEDIAL SIDE OF ANTEROSEPTAL AND POSTEROSEPTAL FOR CLOVER TECHNIQUE. PROCEDURE WAS SUCCESSFUL. THE POST PROCEDURE GRADIENT WAS 3MMHG AND FINAL TR WAS GRADE 1. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED. ON (B)(6) 2026, ON FOLLOW UP WITH THE PHYSICIAN, IT WAS DETERMINED THAT THE MEAN PRESSURE GRADIENT WAS 13MMHG AND PATIENT WAS ASYMPTOMATIC. MULTIPLE MEASUREMENTS WERE WITH CONSISTENT 8-13MMHG.

  Patient problems: Tricuspid Valve Stenosis

  MAUDE report 24260961 ↗
• MalfunctionFeb 4, 2026Device Damaged by Another Device

  IT WAS REPORTED ON (B)(6) 2026 THAT THE PATIENT PRESENTED WITH GRADE 5 FUNCTIONAL TRICUSPID REGURGITATION (TR) FOR A TRICLIP PROCEDURE. DURING THE PROCEDURE, A TRICLIP WAS SUCCESSFULLY IMPLANTED AT ANTERIOR SEPTAL REGION. DURING DEPLOYMENT OF SECOND TRICLIP, A CONTACT BETWEEN FIRST TRICLIP AND SECOND TRICLIP WAS OBSERVED WHICH LEAD TO SINGLE LEAFLET DEVICE ATTACHMENT(SLDA) OF FIRST TRICLIP FROM THE SEPTAL LEAFLET. HOWEVER, SECOND TRICLIP WAS SUCCESSFULLY IMPLANTED STABILIZING THE SLDA CLIP. A THIRD TRICLIP WAS IMPLANTED TO FURTHER REDUCE THE TR TO GRADE 2-3. THERE WAS NO CLINICALLY SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24259295 ↗
• MalfunctionFeb 4, 2026Incomplete Coaptation; Device Damaged by Another Device

  IT WAS REPORTED ON (B)(6) 2026, THAT THE PATIENT PRESENTED WITH GRADE 5 FUNCTIONAL TRICUSPID REGURGITATION (TR) FOR A TRICLIP PROCEDURE. DURING THE PROCEDURE, A TRICLIP WAS SUCCESSFULLY IMPLANTED AT ANTERIOR SEPTAL REGION. DURING DEPLOYMENT OF SECOND TRICLIP, A CONTACT BETWEEN FIRST TRICLIP AND SECOND TRICLIP WAS OBSERVED WHICH LEAD TO SINGLE LEAFLET DEVICE ATTACHMENT(SLDA) OF FIRST TRICLIP FROM THE SEPTAL LEAFLET. HOWEVER, SECOND TRICLIP WAS SUCCESSFULLY IMPLANTED STABILIZING THE SLDA CLIP. A THIRD TRICLIP WAS IMPLANTED TO FURTHER REDUCE THE TR TO GRADE 2-3. THERE WAS NO CLINICALLY SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24259246 ↗
• MalfunctionJan 13, 2026Incomplete Coaptation

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24055656 ↗
• InjuryJan 7, 2026Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2025, A PATIENT PRESENTED WITH GRADE 5 FUNCTIONAL TRICUSPID REGURGITATION (TR) FOR A TRICLIP PROCEDURE. DURING THE PROCEDURE, ONE TRICLIP WAS IMPLANTED SUCCESSFULLY. THE FINAL TR WAS GRADE 2. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED. ON (B)(6) 2025, IT WAS IDENTIFIED THAT THERE WAS A SINGLE LEAFLET DEVICE ATTACHMENT (SLDA). TR WAS GRADE 5 AFTER SLDA AND THE PHYSICIAN PERFORMED ADDITIONAL PROCEDURE FOR VALVE REPLACEMENT. TR WAS GRADE 0 AFTER ADDITIONAL PROCEDURE.

  Patient problems: Dyspnea; No Clinical Signs, Symptoms or Conditions; Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 23995666 ↗
• InjuryJan 7, 2026Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2025, A PATIENT PRESENTED WITH GRADE 4+ FUNCTIONAL TRICUSPID REGURGITATION (TR), ANNULAR DILATION AND THIN LEAFLETS FOR A TRICLIP PROCEDURE. DURING THE PROCEDURE, ONE TRICLIP WAS IMPLANTED ON SEPTAL AND ANTERIOR LEAFLET, AND IT WAS DETERMINED THAT A SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) OCCURRED AND CLIP WAS NO LONGER ATTACHED TO THE ANTERIOR LEAFLET. PER THE PHYSICIAN, SLDA WAS DUE TO PRE-EXISTING PATIENT ANATOMY. IMAGING WAS DIFFICULT. ADDITIONAL TRICLIP WAS IMPLANTED TO STABILIZE THE SLDA. THE FINAL TR WAS GRADE 3-4. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23993742 ↗
• MalfunctionJan 5, 2026Device Damaged by Another Device

  IT WAS REPORTED ON (B)(6) 2025 THAT THE PATIENT PRESENTED WITH GRADE 3 FUNCTIONAL TRICUSPID REGURGITATION (TR) FOR A TRICLIP PROCEDURE. DURING THE PROCEDURE, ONE TRICLIP WAS SUCCESSFULLY IMPLANTED. DURING DEPLOYMENT OF SECOND TRICLIP, THE FIRST TRICLIP HAD SINGLE LEAFLET DEVICE ATTACHMENT(SLDA) FROM THE SEPTAL LEAFLET DUE TO CONTACT WITH THE SECOND CLIP. ADDITIONAL CLIP WAS DEPLOYED TO STABILIZE THE SLDA CLIP. THE TR WAS REDUCED TO GRADE 2 POST PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23957179 ↗
• InjuryJan 5, 2026Incomplete Coaptation; Device Damaged by Another Device

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23957110 ↗
• InjuryJan 2, 2026Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2025, A PATIENT PRESENTED WITH FUNCTIONAL TRICUSPID REGURGITATION (TR) FOR A TRICLIP PROCEDURE. DURING THE PROCEDURE, TRICLIP WAS IMPLANTED SUCCESSFULLY ON ANTERIOR AND SEPTAL LEAFLET. THE FINAL TR WAS GRADE 4. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED. ON (B)(6) 2025, IT WAS DETERMINED THAT A SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) OCCURRED AND CLIP WAS NO LONGER ATTACHED TO THE SEPTAL LEAFLET. TR WAS GRADE 4 AFTER SLDA. PER THE PHYSICIAN, SLDA WAS DUE TO THE PRE-EXISTING PATIENT ANATOMY. ADDITIONAL SECONDARY PROCEDURE WAS PERFORMED AND TRICLIP WAS IMPLANTED TO STABILIZE THE SLDA. THE FINAL TR WAS GRADE 2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23950417 ↗
• InjuryJan 2, 2026Difficult to Remove

  IT WAS REPORTED THAT ON (B)(6) 2025, A PATIENT PRESENTED WITH GRADE 4 FUNCTIONAL TRICUSPID REGURGITATION (TR) AND ROTATED HEART FOR A TRICLIP PROCEDURE. DURING THE PROCEDURE, SEPTAL LEAFLET WAS STUCK ON THE GRIPPER, AND A POSSIBLE TEAR WAS NOTED IN THE SEPTAL TRICUSPID LEAFLET. TRICLIP WAS IMPLANTED ON THE POSSIBLE TEAR OF THE LEAFLET. DURING THE SECOND TRICLIP PROCEDURE, GRASPING WAS DIFFICULT DUE TO BAD IMAGING OF LEAFLETS, AND THE PROCEDURE WAS DISCONTINUED. IMAGING WAS DIFFICULT DUE TO PATIENT ANATOMY. PER THE PHYSICIAN, LEAFLET DAMAGE WAS DUE TO TRICLIP DEVICE. ALL STEPS WERE PERFORMED AS PER IFU. THE FINAL TR WAS GRADE 4. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED.

  Patient problems: Tricuspid Valve Insufficiency/ Regurgitation; Unspecified Tissue Injury

  MAUDE report 23950348 ↗
• MalfunctionDec 31, 2025Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED ON (B)(6) 2025 THAT THE PATIENT PRESENTED WITH GRADE 5 FUNCTIONAL TRICUSPID REGURGITATION (TR), PREVIOUS CARDIAC SURGERY AND RESTRICTED ANTERIOR LEAFLET FOR A TRICLIP PROCEDURE. DURING THE PROCEDURE, IMAGING WAS CHALLENGING DUE TO THE ANATOMY. A TRICLIP WAS SUCCESSFULLY IMPLANTED. POST DEPLOYMENT, THE CLIP HAD SINGLE LEAFLET DEVICE ATTACHMENT(SLDA) FROM THE ANTERIOR LEAFLET. PER THE PHYSICIAN, THE SLDA WAS DUE TO THE PRE-EXISTING PATIENT ANATOMY. THE TR REMAINED UNCHANGED POST PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY OR ADVERSE PATIENT EFFECTS.

  Patient problems: Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 23935099 ↗
• MalfunctionDec 30, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT A TRICLIP PROCEDURE WAS PERFORMED TO TREAT MIXED TRICUSPID REGURGITATION (TR) WITH A GRADE OF 5, ON A PATIENT WITH A PRE-EXISTING FLAIL AND DILATED ANNULUS. A TRICLIP WAS INSERTED AND DEPLOYED ON THE TRICUSPID VALVE. A SECOND CLIP, A TRICLIP XTW WAS INSERTED AND PLACED ON THE VALVE. HOWEVER, WHILE ESTABLISHING FINAL ARM ANGLE (EFAA), IT WAS OBSERVED THE CLIP CONTINUOUSLY OPENED FROM 5 TO 10 DEGREES TO GREATER THAN 60 DEGREES. TROUBLESHOOTING WAS PERFORMED, BUT THE ISSUES CONTINUED TO OCCUR; THEREFORE, THE CLIP DELIVERY SYSTEM (CDS) WAS REMOVED AND REPLACED. ONE CLIP WAS THEN DEPLOYED ON THE TRICUSPID VALVE, REDUCING TR TO A GRADE OF 2-3. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23923502 ↗
• InjuryDec 30, 2025Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED ON 04 DECEMBER 2025 THAT THE PATIENT PRESENTED WITH GRADE 5 FUNCTIONAL TRICUSPID REGURGITATION (TR) FOR A TRICLIP PROCEDURE. DURING THE PROCEDURE, 2 TRICLIPS WERE IMPLANTED SUCCESSFULLY. THE TR WAS REDUCED TO GRADE 2 POST PROCEDURE. ON (B)(6) 2025, ONE TRICLIP HAD SINGLE LEAFLET DEVICE ATTACHMENT(SLDA). RECURRENT TR OF GRADE 5+ WAS REPORTED. ON (B)(6) 2025, A RE-INTERVENTION PROCEDURE WAS PERFORMED. ADDITIONAL TRICLIP WAS IMPLANTED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY. CODES 2199 AND 4582 WERE REMOVED. CODE 4607, 4641- ADDITIONAL PROCEDURE AND 4453-RECURRENT TR WERE AS ADDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 23923338 ↗
• MalfunctionDec 29, 2025Difficult or Delayed Positioning; Difficult to Remove; No Apparent Adverse Event; Difficult or Delayed Positioning; Difficult to Remove; No Apparent Adverse Event

  IT WAS REPORTED THAT A TRICLIP PROCEDURE WAS PERFORMED TO TREAT FUNCTIONAL TRICUSPID REGURGITATION (TR) WITH A GRADE OF 4. A TRICLIP WAS INSERTED AND DEPLOYED ON THE TRICUSPID VALVE. A SECOND CLIP, A TRICLIP WAS THEN INSERTED AND STEERED DOWN TO THE VALVE. HOWEVER, THERE WAS VERY LITTLE HEIGHT ABOVE THE VALVE AND DIFFICULT TRAJECTORY. AN ATTEMPT TO OPEN AND ORIENT THE CLIP WAS MADE, BUT THE CLIP ENDED UP UNDER ONE OF THE LEAFLETS. THE CLIP WAS INVERTED AND BROUGHT BACK TO THE RIGHT ATRIUM (RA). TROUBLESHOOTING WAS PERFORMED, BUT THE CLIP WAS STILL UNABLE TO BE ACHIEVE A GOOD POSITION. AFTER SEVERAL ATTEMPTS, THE CLIP WAS RETRACTED BACK INTO THE STEERABLE GUIDE CATHETER (SGC). HOWEVER, IT WAS OBSERVED THAT THE SGC WAS INTERACTING WITH THE EUSTACHIAN VALVE. SEVERAL ATTEMPTS WERE MADE TO GET THE CLIP BACK INTO THE SGC. THEREFORE, A DECISION WAS MADE TO REMOVE THE CLIP. THE CLIP WAS REMOVED AND REPLACED. ONE CLIP WAS THEN INSERTED AND DEPLOYED ON THE TRICUSPID VALVE, REDUCING TR TO A GRADE OF 1. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23907097 ↗
• MalfunctionDec 24, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT A TRICLIP PROCEDURE WAS PERFORMED TO TREAT FUNCTIONAL TRICUSPID REGURGITATION (TR) WITH A GRADE OF 4 ON A PATIENT WITH A PROMINENT EUSTACHIAN VALVE. A TRICLIP STEERABLE GUIDE CATHETER AND A TRICLIP WAS INSERTED. HOWEVER, THE DEVICE WAS INTERACTING WITH THE EUSTACHIAN VALVE IN A WAY THAT WAS PREVENTING THE ABILITY TO STEER AND MANIPULATE THE CLIP DELIVERY SYSTEM (CDS) AS INTENDED. DUE TO THESE CHALLENGES, DIFFICULTY UNDERSTRADDLING THE CLIP BACK INTO THE GUIDE OCCURRED, BUT WERE FINALLY ABLE TO GET THE CLIP BACK INTO THE GUIDE. THEREFORE, THE TSGC AND CDS WERE REMOVED FROM THE PATIENT. THE TSGC WAS INSPECTED, AND THERE WAS NO DAMAGE OBSERVED. THEREFORE, A NEW TSGC AND A NEW TRICLIP WAS USED TO COMPLETE THE PROCEDURE. ONE CLIP WAS IMPLANTED, REDUCING TR TO A GRADE OF 1. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23889872 ↗
• MalfunctionDec 23, 2025Difficult to Remove; No Apparent Adverse Event; Difficult to Remove; No Apparent Adverse Event

  N/A.

  Patient problems: Cardiac Tamponade; Myocardial Infarction; No Clinical Signs, Symptoms or Conditions; Pericardial Effusion; Unspecified Tissue Injury

  MAUDE report 23883017 ↗
• InjuryDec 19, 2025Incomplete Coaptation; Incomplete Coaptation

  ON (B)(6) 2025 THAT THE PATIENT PRESENTED WITH GRADE 5+ FUNCTIONAL TRICUSPID REGURGITATION (TR) AND DILATED RIGHT ATRIUM FOR A TRICLIP PROCEDURE. DURING THE PROCEDURE, 3 TRICLIPS WERE SUCCESSFULLY IMPLANTED. THE TR WAS REDUCED TO GRADE 1+ POST PROCEDURE. ON (B)(6) 2025, THE THIRD TRICLIP HAD SINGLE LEAFLET DEVICE ATTACHMENT(SLDA). THERE WAS NO CLINICALLY SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 23853904 ↗
• MalfunctionDec 16, 2025Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THAT A TRICLIP PROCEDURE WAS PERFORMED TO TREAT FUNCTIONAL TRICUSPID REGURGITATION (TR) WITH A GRADE OF 5+, DILATED LEFT ATRIUM, TETHERED LEAFLET, VERY RESTRICTED LEAFLETS AND COAPATION GAP. TWO TRICLIPS WERE INSERTED AND DEPLOYED ON THE TRICUSPID VALVE WITHOUT ISSUES. A THIRD CLIP, A TRICLIP XTW WAS INSERTED AND DEPLOYED ON THE TRICUSPID VALVE. HOWEVER, POST DEPLOYMENT, THE CLIP DETACHED FROM THE SEPTAL LEAFLET AND REMAINED ATTACHED TO THE POSTERIOR LEAFLET (SINGLE LEAFLET DEVICE ATTACHMENT/SLDA). NO ADDITIONAL CLIPS WERE IMPLANTED, AND THE TR WAS REDUCED TO A GRADE OF 2+. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23822221 ↗