TriClip™ TCDS0801-XTRecalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 05415067050847), received between Jun 12, 2025 and Sep 18, 2026 — classified as 23 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Incomplete Coaptation” (17 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 49 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Difficult or Delayed Activation

  It was reported that on (b)(6) 2026 a patient presented with grade 5 degenerative tricuspid regurgitation (TR) for a Triclip procedure. During the procedure, while deploying triclip XT, actuator knob was turned 11 times, and the actuator knob was not released from the clip. Actuator knob was released when physician pulled the actuator knob out and the device was implanted. The final TR was grade 1. There were no adverse patient effects or clinically significant delays reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50820190 ↗
• InjuryAug 3, 2026Difficult to Remove; Unintended Movement

  It was reported that on (b)(6) 2026, a patient presented with grade 5 functional tricuspid regurgitation (TR) and rotated heart for a Triclip procedure. During the procedure, triclip was advanced into the tricuspid valve and when tried to retract into the right atrium, clip got stuck in the chordae and flail segment was observed. Lock knob was removed, lock was tested and the clip was opened to 60 degrees. Physician unlocked the clip, relocked, closed and tested the lock, clip opened to 60 degrees. Physician unlocked the clip, opened to 120 degrees, relocked and closed the clip. Physician tested twice before deployment sequence and was implanted. All steps were performed as per IFU. The final TR was grade 2. There were no adverse patient effects or clinically significant delays reported.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50119852 ↗
• MalfunctionJul 31, 2026Break; Difficult or Delayed Positioning; Difficult to Open or Close

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50103705 ↗
• InjuryJul 31, 2026Improper or Incorrect Procedure or Method; Incomplete Coaptation

  It was reported that on (b)(6) 2026, a patient presented with grade 4 functional tricuspid regurgitation (TR) and rotated heart for a Triclip procedure. During the procedure, first triclip was implanted and second triclip was implanted on the medial side of posterior and septal leaflet. it was determined that there was a single leaflet device attachment (SLDA) and the clip was no longer attached to the septal leaflet. Third triclip was implanted to stabilize the SLDA. Imaging was difficult. The final TR was grade 2. There were no adverse patient effects or clinically significant delays reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50099020 ↗
• MalfunctionJun 30, 2026Unintended Movement

  IT WAS REPORTED ON (B)(6) 2026 THAT THE PATIENT PRESENTED WITH GRADE 3 FUNCTIONAL TRICUSPID REGURGITATION (TR) FOR A TRICLIP PROCEDURE. DURING THE PROCEDURE, THE CLIP FAILED LOCK TEST AS IT OPENED UP 70 DEGREES CONTINOUSLY. TROUBLESHOOTING RESOLVED THE ISSUE. AS A RESULT, THE CLIP WAS IMPLANTED SUCCESSFULLY. ANOTHER TRICLIP WAS ALSO IMPLANTED. THE TR WAS REDUCED TO GRADE 1 POST PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY OR ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25669381 ↗
• InjuryJun 29, 2026Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT PRESENTED WITH GRADE 5 FUNCTIONAL TRICUSPID REGURGITATION (TR) FOR A TRICLIP PROCEDURE. DURING THE PROCEDURE, A STEERABLE GUIDE CATHETER (SGC) WOULD NOT CLICK INTO THE STABILIZER SMOOTHLY. IT WAS NOTED THAT THE PHYSICIAN REQUIRED INCREASED FORCE TO INSERT SGC INTO THE STABILIZER. A TRICLIP XT WAS THEN ADVANCED WITHIN THE PATIENT AND SUCCESSFULLY PLACED ON THE LEAFLETS. AFTER DEPLOYMENT, A SINGLE LEAFLET DETACHMENT (SLDA) OCCURRED. A SECOND TRICLIP XT WAS SELECTED AND PLACED ON THE LEAFLET TO STABILIZE THE SLDA CLIP AND FURTHER REDUCE THE TR. UPON DEPLOYMENT, THE SECOND CLIP HAD AN SLDA. THE PROCEDURE WAS DISCONTINUED, THE FINAL TR REMAINED AT GRADE 5. THERE WERE NO ADVERSE PATIENT SEQUELA OR CLINICALLY SIGNIFICANT DELAYS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25660746 ↗
• InjuryJun 3, 2026Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT PRESENTED WITH GRADE 5 FUNCTIONAL TRICUSPID REGURGITATION (TR) AND ANNULAR DILATION FOR A TRICLIP PROCEDURE. DURING THE PROCEDURE, FIRST TRICLIP XTW WAS IMPLANTED ON THE CENTRAL SIDE OF ANTERIOR AND SEPTAL LEAFLET AND SECOND TRICLIP XT WAS IMPLANTED ON CENTRAL SIDE OF POSTERIOR AND SEPTAL LEAFLET. IT WAS UNCLEAR WHETHER THERE WAS COMPLETE GRASP OF THE SEPTAL LEAFLET. UPON DEPLOYMENT, IT WAS DETERMINED THAT THERE WAS A SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) AND THE CLIP WAS NO LONGER ATTACHED TO THE SEPTAL LEAFLET. THIRD TRICLIP XT WAS IMPLANTED ON THE CENTRAL SIDE OF POSTERIOR AND SEPTAL LEAFLET TO STABILIZE THE SLDA. IMAGING WAS DIFFICULT. THE FINAL MR WAS GRADE <1. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25386098 ↗
• InjuryJun 3, 2026Incomplete Coaptation; Device Damaged by Another Device

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT PRESENTED WITH GRADE 5+ FUNCTIONAL TRICUSPID REGURGITATION (TR), SEPTAL LEAFLET HAD A CENTRAL CLEFT AND SIGNIFICANT AMOUNT OF CHORDAE FOR A TRICLIP PROCEDURE. DURING THE PROCEDURE, FIRST AND SECOND TRICLIPS WERE IMPLANTED. WHILE IMPLANTING THE THIRD CLIP ON THE MEDIAL SIDE OF POSTERIOR AND SEPTAL REGION OF THE VALVE, THE CLIP BECAME ENGAGED WITH THE SEPTAL LEAFLET AND CHORDAE, IT WAS OBSERVED THAT THE PHYSICIAN HAD DISLODGED SECOND TRICLIP FROM THE ANTERIOR LEAFLET WHILE TRYING TO FREE THE THIRD TRICLIP. THIRD TRICLIP WAS NOT ABLE TO BE REMOVED FROM THE SEPTAL LEAFLET AND WAS DECIDED TO IMPLANT BY CAPTURING BOTH THE LEAFLETS. LEAFLETS WERE CAPTURED, AFTER REMOVING THE LOCK LINE, IT WAS OBSERVED THAT THE POSTERIOR LEAFLET HAD COME OUT OF THE CLIP. ADDITIONAL MITRACLIP XTW WAS IMPLANTED ON CENTRAL SIDE OF ANTERIOR AND SEPTAL LEAFLET TO STABILIZE THE SLDA. THE FINAL TR WAS GRADE 5. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25386070 ↗
• InjuryJun 3, 2026Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT PRESENTED WITH GRADE 5 FUNCTIONAL TRICUSPID REGURGITATION (TR) AND A PACER LEAD PINING THE POSTERIOR LEAFLET FOR A TRICLIP PROCEDURE. DURING THE PROCEDURE, A TRICLIP WAS INTENDED TO BE IMPLANTED IN THE ANTERIOR-POSTERIOR (A/P) LEAFLET POSITION WHILE PINING THE HEART MONITOR LEAD INTO THE AP CANYON. DURING POSITIONING, THE CLIP WAS SUCCESSFULLY PLACED BUT THERE WERE CHALLENGES VISUALIZING THE INSERTION OF THE LEAFLETS WITHIN THE CLIP. THE CLIP WAS SUCCESSFULLY DEPLOYED WHEN IT WAS VISUALIZED THAT THE CLIP WAS ONLY ATTACHED TO THE ANTERIOR LEAFLET. A SECOND CLIP WAS INTENDED TO BE PLACED CENTRALLY ON THE ANTERIOR/SEPTAL (A/S) LEAFLETS. DURING POSITIONING, THE CLIP BECAME CAUGHT ON THE SEPTAL CHORDAE. TROUBLESHOOTING WAS PERFORMED AND THE F-KNOB WAS TURNED SIGNIFICANTLY, OUTSIDE OF THE IFU, WHEN THE F-KNOB CABLE BROKE. THE +/- KNOB ON THE STEERABLE GUIDE CATHETER (SGC) WAS UTILIZED TO MANEUVER THE CLIP INTO THE A/S COMMISSURE. THE CLIP WAS DEPLOYED SUCCESSFULLY ON BOTH LEAFLETS WITH SOME CHORDAE ATTACHED. THE PROCEDURE WAS DISCONTINUED, FINAL MR WAS REDUCED TO GRADE 4. THERE WERE NO ADVERSE PATIENT SEQUELA OR CLINICALLY SIGNIFICANT DELAYS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25382936 ↗
• MalfunctionMay 26, 2026Incomplete Coaptation

  IT WAS REPORTED ON (B)(6) 2026 THAT THE PATIENT PRESENTED WITH GRADE 4+ FUNCTIONAL TRICUSPID REGURGITATION (TR) AND RESTRICTED SEPTAL LEAFLET FOR A TRICLIP PROCEDURE. DURING THE PROCEDURE, A TRICLIP WAS SUCCESSFULLY IMPLANTED. POST DEPLOYMENT, THE CLIP HAD SINGLE LEAFLET DEVICE ATTACHMENT(SLDA) FROM THE SEPTAL LEAFLET. THE TR REMAINED UNCHANGED POST PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY OR ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 25279023 ↗
• InjuryMay 21, 2026Material Deformation; Mechanical Jam; Physical Resistance/Sticking

  IT WAS REPORTED ON (B)(6) 2026, THAT THE PATIENT PRESENTED WITH GRADE 4-5 FUNCTIONAL TRICUSPID REGURGITATION (TR) FOR A TRICLIP PROCEDURE. DURING THE PROCEDURE, A TRICLIP WAS SUCCESSFULLY IMPLANTED. DURING DEPLOYMENT SEQUENCE OF SECOND TRICLIP, RESISTANCE WAS ENCOUNTERED DUE TO PRESENCE OF KNOT WHILE REMOVING LOCK LINE. THE LOCK LINE WAS CUT AND THE CLIP DELIVERY SYSTEM HANDLE WAS REMOVED. THE LINE WAS REMOVED COMPLETELY AND THE CLIP WAS DEPLOYED SUCCESSFULLY. THE TR WAS REDUCED TO GRADE 2 POST PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25246479 ↗
• MalfunctionMay 15, 2026Unintended Movement

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT PRESENTED WITH GRADE 5 FUNCTIONAL TRICUSPID REGURGITATION (TR) AND AN ENLARGED ATRIUM FOR A TRICLIP PROCEDURE. DURING THE PROCEDURE, A TRICLIP WAS IMPLANTED SUCCESSFULLY. A SECOND TRICLIP WAS SUCCESSFULLY IMPLANTED. A THIRD TRICLIP WAS SUCCESSFULLY PLACED ON THE LEAFLETS. DURING THE LOCK LINE TESTING THE CLIP OPENED. TROUBLESHOOTING WAS PERFORMED AND THE CLIP REMAINED CLOSED DURING FURTHER TESTING. THE CLIP WAS SUCCESSFULLY DEPLOYED WHEN THE CLIP OPENED. THE PROCEDURE WAS DISCONTINUED; THE FINAL TR WAS REDUCED TO GRADE 2. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25187519 ↗
• InjuryMay 4, 2026Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT PRESENTED WITH GRADE 4 FUNCTIONAL TRICUSPID REGURGITATION (TR), AND DILATED ATRIUM FOR A TRICLIP PROCEDURE. DURING THE PROCEDURE, TRICLIP WAS IMPLANTED. SHORTLY AFTER RELEASE, IT WAS DETERMINED THAT THERE WAS A SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) AND THE CLIP WAS NO LONGER ATTACHED TO THE SEPTAL LEAFLET. ADDITIONAL CLIP WAS IMPLANTED TO STABILIZE THE SLDA. THE FINAL TR WAS GRADE 1. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25072253 ↗
• InjuryMay 4, 2026Difficult or Delayed Positioning; Difficult to Remove; Deformation Due to Compressive Stress

  It was reported that on (b)(6) 2026, a patient presented with grade 4 functional tricuspid regurgitation (TR) and tethered leaflet for a Triclip procedure. During the procedure, it was noted that clip got stuck in the chords below the valve. It was able to free the clip from the chords and moved into the atrium. it was decided to remove the second clip as mandrel was bent. It was attempted to pull the clip back into the guide and it was noticed that one of the clip arms would not come into the guide due to the mandrel being visibly bent. Physician was able to pull the triclip steerable guide catheter (TSGC) and clip delivery system (CDS) into the groin. Vascular surgeon came in and cut down to the vein to remove the clip. The final TR was grade 2. All steps were performed as per IFU. There were no adverse patient effects or clinically significant delays reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25071920 ↗
• InjuryMay 4, 2026Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT PRESENTED WITH GRADE 4 FUNCTIONAL TRICUSPID REGURGITATION (TR), RESTRICTED SEPTAL LEAFLET AND LARGE COAPTATION GAP FOR A TRICLIP PROCEDURE. DURING THE PROCEDURE, TRICLIP WAS IMPLANTED. UPON DEPLOYMENT, IT WAS DETERMINED THAT THERE WAS A SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) AND THE CLIP WAS NO LONGER ATTACHED TO THE ANTERIOR LEAFLET. IMAGING WAS DIFFICULT DUE TO THE PATIENT ANATOMY. SECOND TRICLIP WAS IMPLANTED TO TREAT TR. THE FINAL MR WAS GRADE 2. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25071751 ↗
• MalfunctionApr 21, 2026Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT PRESENTED WITH GRADE 4 FUNCTIONAL TRICUSPID REGURGITATION (TR) FOR A TRICLIP PROCEDURE. DURING THE PROCEDURE, TWO TRICLIPS WERE IMPLANTED. THE FINAL TR WAS GRADE 2. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED. ON (B)(6) 2026 UNDER TRANSTHORACIC ECHOCARDIOGRAM (TTE)IT WAS DETERMINED THAT THERE WAS A SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) FOR SECOND CLIP AND THE CLIP WAS NO LONGER ATTACHED TO THE POSTERIOR LEAFLET. PATIENT HAD SHORTNESS OF BREATH ON THE NEXT DAY. TR WAS GRADE 2 AFTER SLDA.

  Patient problems: Dyspnea

  MAUDE report 24944480 ↗
• MalfunctionApr 13, 2026Unintended Movement

  IT WAS REPORTED ON (B)(6) 2026 THAT THE PATIENT PRESENTED WITH GRADE 3-4 FUNCTIONAL TRICUSPID REGURGITATION (TR), VESSEL TORTUOSITY, ENLARGED RIGHT ATRIUM AND A ROTATED HEART FOR A TRICLIP PROCEDURE. DURING THE PROCEDURE, 2 TRICLIPS WERE IMPLANTED. DURING DEPLOYMENT OF THIRD TRICLIP, THE CLIP WAS UNABLE TO PASS ESTABLISH FINAL ARM ANGLE TEST (EFAA) TEST. THE CLIP WAS REMOVED FROM THE ANATOMY. ANOTHER TRICLIP XT WAS IMPLANTED. THE TR WAS REDUCED TO GRADE 1 POST PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY OR ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24858623 ↗
• MalfunctionApr 10, 2026Difficult or Delayed Activation

  IT WAS REPORTED THAT A TRICLIP PROCEDURE WAS PERFORMED TO TREAT FUNCTIONAL TRICUSPID REGURGITATION (TR) WITH A GRADE OF 5. A TRICLIP XT WAS INSERTED AND DEPLOYED ON THE TRICUSPID VALVE. A SECOND CLIP, A TRICLIP XT WAS THEN INSERTED AND ADVANCED TO THE VALVE. HOWEVER, DURING DEPLOYMENT, DIFFICULTIES DETACHING CLIP FROM THE CLIP DELIVERY SYSTEM (CDS) OCCURRED. IT WAS NOTED THAT THE CLIP WAS FINALLY RELEASED AFTER SOME EFFORTS. THE CDS WAS REMOVED FROM THE PATIENT, AND THE PATIENT WAS COMPLETED WITH TWO CLIPS IMPLANTED, REDUCING TR WITH A GRADE OF 1-2. IT WAS NOTED THAT PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24840044 ↗
• MalfunctionApr 6, 2026Difficult to Open or Close

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT PRESENTED WITH GRADE 3-4 FUNCTIONAL TRICUSPID REGURGITATION (TR) AND ENLARGED ATRIUM FOR A TRICLIP PROCEDURE. DURING THE PROCEDURE, WHEN PERFORMING THE GRIPPER IDENTIFICATION IN THE RIGHT ATRIUM, ONE OF THE GRIPPERS WOULD NOT LOWER WHEN GRASPING. TROUBLESHOOTING STEPS WERE PERFORMED BUT WAS UNSUCCESSFUL. PHYSICIAN WAS ABLE TO CLOSE THE CLIP WITH THE GRIPPER IN THE LOWERED POSITION. CLIP WAS DEPLOYED SUCCESSFULLY. THE FINAL TR WAS GRADE 2. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24793146 ↗
• InjuryMar 24, 2026Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT PRESENTED WITH GRADE 4 FUNCTIONAL TRICUSPID REGURGITATION (TR) FOR A TRICLIP PROCEDURE. DURING THE PROCEDURE, A TRICLIP XT WAS SUCCESSFULLY PLACED ON THE MID ANTERIOR- SEPTAL (A/S) LEAFLET POSITION. UPON DEPLOYMENT, A SINGLE LEAFLET DETACHMENT (SLDA) OCCURRED AND THE CLIP WAS NO LONGER ATTACHED TO THE SEPTAL LEAFLET. A SECOND TRICLIP XT WAS SUCCESSFULLY PLACED ANTERIOR TO THE SLDA CLIP FOR STABILIZATION. A THIRD TRICLIP XT WAS THEN IMPLANTED CENTRALLY ON THE A/S SEGMENT TO REDUCE TR. THE PROCEDURE WAS DISCONTINUED, THE FINAL TR WAS GRADE <1. THERE WERE NO ADVERSE PATIENT SEQUELA OR CLINICALLY SIGNIFICANT DELAYS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24682392 ↗
• MalfunctionMar 20, 2026Leak/Splash

  IT WAS REPORTED ON (B)(6) 2026 THAT THE PATIENT PRESENTED WITH GRADE 5 FUNCTIONAL TRICUSPID REGURGITATION (TR) FOR A TRICLIP PROCEDURE. DURING THE PREPARATION OF THE TRICLIP, LEAK WAS OBSERVED IN THE FLUSH PORT OF THE CLIP. TROUBLESHOOTING WAS PERFORMED AND WAS UNSUCCESSFUL. THE CLIP WAS REPLACED WITH ANOTHER DEVICE TO COMPLETE THE PROCEDURE. 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 24653467 ↗
• InjuryMar 16, 2026Difficult or Delayed Positioning; Incomplete Coaptation

  IT WAS REPORTED THAT A TRICLIP PROCEDURE WAS PERFORMED TO TREAT FUNCTIONAL TRICUSPID REGURGITATION (TR) WITH A GRADE OF 5 ON A PATIENT WITH PROMINENT EUSTACHIAN VALVE, ENLARGED HEART, ROTATED HEART, AND A CARDIAC IMPLANTABLE ELECTRONIC DEVICE (CIED) WITH PACING LEADS. A TRICLIP WAS INSERTED AND IMPLANTED WITHOUT ISSUES. A SECOND CLIP, A TRICLIP XT WAS INSERTED AND GRASPING WAS PERFORMED. HOWEVER, DIFFICULTIES VISUALIZING THE CLIP AND DIFFICULTIES CAPTURING THE LEAFLETS OCCURRED. THE CLIP WAS ULTIMATELY DEPLOYED ON THE TRICUSPID VALVE. HOWEVER, POST DEPLOYMENT, THE CLIP DETACHED FROM THE ANTERIOR (LATERAL) LEAFLET AND REMAINED ATTACHED TO THE SEPTAL LEAFLET (SINGLE LEAFLET DEVICE ATTACHMENT/SLDA). TO STABILIZE THE CLIP, TWO ADDITIONAL CLIPS WERE IMPLANTED, REDUCING TR WITH A GRADE OF 3-4. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24613325 ↗
• InjuryMar 2, 2026Difficult to Flush; Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT PRESENTED WITH GRADE 5 FUNCTIONAL TRICUSPID REGURGITATION (TR), ENLARGED ATRIUM AND LARGE LEAFLET GAP FOR A TRICLIP PROCEDURE. DURING THE PROCEDURE, FIRST TRICLIP WAS IMPLANTED ON MEDIAL SIDE OF ANTERIOR AND SEPTAL LEAFLET (A/S). SECOND TRICLIP WAS IMPLANTED ON THE CENTRAL SIDE IF ANTERIOR AND SEPTAL LEAFLET (A/S). THIRD TRICLIP WAS IMPLANTED ON THE CENTRAL SIDE OF ANTERIOR AND SEPTAL LEAFLET (A/S). AFTER RELEASING THE THIRD CLIP, IT WAS DETERMINED THAT A SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) HAS OCCURRED AND CLIP WAS NO LONGER ATTACHED TO THE ANTERIOR LEAFLET. FOURTH CLIP WAS IMPLANTED ON THE POSTERIOR LEAFLET 2 AND SEPTAL LEAFLET (P2/S). FIFTH CLIP WAS IMPLANTED ON POSTERIOR LEAFLET 1 AND SEPTAL LEAFLET (P1/S) TO STABILIZE THE SLDA. IT WAS REPORTED THAT DURING PREPARATIONS OF ALL OF THE CDS DEVICES IT REQUIRED ADDITIONAL TROUBLESHOOTING OF ADVANCING AND RETRACTING THE DEVICE MULTIPLE TIMES AT A CONSISTENT AND SLOW PLACE TO THOROUGHLY DE-AIR THE SYSTEM. THE FINAL TR WAS GRADE 1-2. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24484744 ↗
• MalfunctionFeb 26, 2026Unintended Movement

  IT WAS REPORTED ON (B)(6) 2026 THAT THE PATIENT PRESENTED WITH GRADE 5 FUNCTIONAL TRICUSPID REGURGITATION (TR) AND LARGE EUSTACHIAN VALVE FOR A TRICLIP PROCEDURE. DURING THE PROCEDURE, 2 TRICLIPS WERE SUCCESSFULLY IMPLANTED. DURING DEPLOYMENT SEQUENCE OF THIRD TRICLIP, THE CLIP WAS UNABLE TO PASS ESTABLISH FINAL ARM ANGLE TEST (EFAA) AS IT OPENED CONTINUOUSLY. TROUBLESHOOTING WAS PERFORMED AND WAS UNSUCCESSFUL. THE CLIP WAS REPLACED WITH ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE TR WAS REDUCED TO GRADE <1 POST PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY OR ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24462574 ↗
• MalfunctionFeb 24, 2026Difficult to Flush

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24434760 ↗