TriClip™ TCDS0301-XTRecalls & reported problems

Summary

The FDA's MAUDE database contains 62 adverse event reports that list this exact device (DI 05415067047731), received between May 22, 2024 and Sep 23, 2026 — classified as 34 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Incomplete Coaptation” (30 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 62 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Difficult to Insert; Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50874482 ↗
• 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: Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 25046554 ↗
• InjuryFeb 27, 2026Entrapment of Device; Improper or Incorrect Procedure or Method; Expulsion; Unintended Movement

  IT WAS REPORTED THAT ON ((B)(6) 2026, A PATIENT PRESENTED WITH GRADE 4 DEGENERATIVE TRICUSPID REGURGITATION (TR) AND ROTATED HEART FOR A TRICLIP PROCEDURE AND WITH MITRAL REGURGITATION (MR) FOR MITRACLIP PROCEDURE. DURING THE PROCEDURE, A STEERABLE GUIDE CATHETER WAS UNABLE TO CROSS THE SEPTUM AND UNABLE TO TREAT THE MITRAL VALVE. IT WAS DECIDED TO TREAT THE TR. TRICLIP WAS STUCK IN THE TISSUE AND WAS DEPLOYED IN THE RIGHT ATRIUM. CLIP WAS DEPLOYED PRIOR TO REMOVING THE LOCK LINE. WHILE REMOVING THE LOCK LINE, THE CLIP WAS OPENED. AFTER DEPLOYMENT, THE CLIP WAS EMBOLIZED, MOVED ACROSS THE ATRIAL SEPTAL DEFECT (ASD) INTO THE LEFT ATRIUM AND LODGING INTO THE PULMONARY VEIN. IMAGING WAS DIFFICULT. PATIENT WAS SENT TO THE OPEN-HEART SURGERY, AND THE SURGEON SUCCESSFULLY REMOVED THE DEVICE AND REPAIRED THE TRICUSPID VALVE. THE FINAL TR WAS GRADE 4. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED.

  Patient problems: Embolism/Embolus; Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 24470062 ↗
• MalfunctionDec 25, 2025Incomplete Coaptation; Incomplete Coaptation

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23892525 ↗
• MalfunctionDec 8, 2025Break; Device Damaged by Another Device; Break; Device Damaged by Another Device

  IT WAS REPORTED THAT ON (B)(6) 2025, A PATIENT PRESENTED WITH GRADE 5+ FUNCTIONAL TRICUSPID REGURGITATION FOR A TRICLIP PROCEDURE. DURING DEVICE PREPARATION, IT WAS IDENTIFIED THAT THE TRICLIP XT WAS DAMAGED. THE CLIP WAS DISCARDED AND A NEW CLIP WAS SELECTED. A NEW TRICLIP XT WAS SELECTED AND IMPLANTED SUCCESSFULLY. THE FINAL TR WAS REDUCED TO GRADE 1+. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23751552 ↗
• InjuryDec 2, 2025Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THAT A TRICLIP PROCEDURE WAS PERFORMED TO TREAT FUNCTIONAL TRICUSPID REGURGITATION (TR) WITH A GRADE OF 5 AND A COAPTATION GAP. A FIRST CLIP, A TRICLIP WAS INSERTED AND DEPLOYED ON THE TRICUSPID VALVE. A SECOND CLIP, A TRICLIP XT, WAS INSERTED AND DEPLOYED ON THE TRICUSPID VALVE. HOWEVER, DIFFICULTIES VISUALIZING THE CLIP OCCURRED, AND AFTER DEPLOYMENT, THE SECOND CLIP DETACHED FROM ONE LEAFLET AND REMAINED ATTACHED TO THE OTHER LEAFLET (SINGLE LEAFLET DEVICE ATTACHMENT/SLDA). TO STABILIZE THE CLIP, A THIRD CLIP WAS IMPLANTED, REDUCING TR TO A GRADE OF 3. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23697715 ↗
• InjuryDec 2, 2025Off-Label Use; Incomplete Coaptation; Off-Label Use; Incomplete Coaptation

  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, ONE MITRACLIP WAS IMPLANTED, ONE TRICLIP WAS IMPLANTED ON ANTERIOR AND SEPTAL LEAFLET (A/S) AND SECOND TRICLIP WAS IMPLANTED ON POSTERIOR AND SEPTAL LEAFLET (P/S) AND IT WAS DETERMINED THAT SECOND CLIP HAD SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) AND THE CLIP WAS NO LONGER ATTACHED TO THE SEPTAL LEAFLET. ADDITIONAL THIRD TRICLIP WAS IMPLANTED TO STABILIZE THE SLDA. THE FINAL TR WAS GRADE 3. THERE WERE NO CLINICALLY SIGNIFICANT DELAYS OR ADVERSE PATIENT SEQUELA REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23697679 ↗
• InjuryNov 19, 2025Incomplete Coaptation; Migration; Incomplete Coaptation; Migration

  IT WAS REPORTED ON (B)(6) 2025 THAT THE PATIENT PRESENTED WITH GRADE 5+ FUNCTIONAL TRICUSPID REGURGITATION (TR) WITH PACEMAKER LEAD FOR A TRICLIP PROCEDURE. DURING THE PROCEDURE, 2 MITRACLIPS WERE IMPLANTED SUCCESSFULLY ON THE ANTERIOR AND SEPTAL LEAFLETS. THE FINAL TR WAS GRADE 1-2. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED. ON (B)(6) 2025, TEE (TRANSESOPHAGEAL ECHOCARDIOGRAM) WAS PERFORMED WHERE IT WAS DETERMINED THAT THERE WAS A MOVEMENT OF CLIP AND SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) FROM ANTERIOR LEAFLET. IMAGING WAS DIFFICULT. PER THE PHYSICIAN, THE PARTIAL CLIP MOVEMENT AND SLDA WAS DUE TO SO MUCH PRESSURE ON THE CLIP AS PATIENT HAS DECIDED TO STOP TAKING THE MEDICATIONS WHICH LEAD TO HEART DILATING. TR WAS GRADE 3-4 AFTER SLDA. ADDITIONAL TRICLIP WAS IMPLANTED ON THE ANTERIOR AND SEPTAL LEAFLET FOR STABILIZATION. THE TR WAS REDUCED TO GRADE 1-2.

  Patient problems: Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 23593951 ↗
• InjuryOct 31, 2025Incomplete Coaptation; Device Damaged by Another Device; Incomplete Coaptation; Device Damaged by Another Device

  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 SUCCESSFULLY. THE TR WAS REDUCED TO GRADE 1 POST PROCEDURE. ON (B)(6) 2025, FIRST TRICLIP WAS OBSERVED TO HAVE SINGLE LEAFLET DEVICE ATTACHMENT(SLDA) FROM SEPTAL LEAFLET. DUE TO THE MOVEMENT OF FIRST TRICLIP, SECOND TRICLIP ALSO HAD SLDA FROM SEPTAL LEAFLET. THE PATIENT RETURNED WITH RECURRENT TR OF GRADE 3. THERE WAS NO CLINICALLY SIGNIFICANT DELAY.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation; Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 23442107 ↗
• MalfunctionSep 8, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED ON (B)(6) 2025 THAT THE PATIENT PRESENTED WITH GRADE 4 FUNCTIONAL TRICUSPID REGURGITATION (TR) FOR A TRICLIP PROCEDURE. DURING THE PROCEDURE, TRICLIP XTW WAS IMPLANTED SUCCESSFULLY. AN ATTEMPT WAS MADE TO DEPLOY TRICLIP XT. THE CLIP OPENED TO 20-30 DEGREES POST DEPLOYMENT. THE TR WAS REDUCED TO GRADE 1 POST PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY OR ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22999076 ↗
• InjuryAug 21, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT PRESENTED WITH GRADE 3+ MIXED TRICUSPID REGURGITATION FOR A TRICLIP PROCEDURE. DURING THE PROCEDURE, A TRICLIP WAS IMPLANTED SUCCESSFULLY. WHILE ATTEMPTING TO IMPLANT A SECOND TRICLIP, THE CLIP BECAME ENTANGLED WITHIN THE SUB VALVULAR APPARATUS. TROUBLESHOOTING WAS PERFORMED UNSUCCESSFULLY AND THE CLIP COULD NOT BE FREED. THE CLIP WAS DEPLOYED WITHIN THE CHORDAE WITHOUT ANY LEAFLET INSERTION. THE PROCEDURE WAS DISCONTINUED. THE FINAL TR WAS GRADE 2+. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22865974 ↗
• MalfunctionAug 13, 2025Incomplete Coaptation; Incomplete Coaptation

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22796281 ↗
• MalfunctionAug 12, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT DURING PREPARATION OF A TRICLIP XT, THE GRIPPERS DID NOT LOWER. TROUBLESHOOTING WAS PERFORMED, BUT THE ISSUE CONTINUED TO OCCUR. THEREFORE, THE CLIP WAS NOT USED AND WAS REPLACED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22787216 ↗
• MalfunctionAug 11, 2025Difficult to Open or Close; Difficult to Open or Close

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22775862 ↗
• InjuryAug 8, 2025Positioning Failure; Premature Activation; Unintended Movement; Positioning Failure; Premature Activation; Unintended Movement

  IT WAS REPORTED THAT A TRICLIP PROCEDURE WAS PERFORMED TO TREAT DEGENERATIVE TRICUSPID REGURGITATION (TR) WITH A GRADE OF 4-5. A TRICLIP XT WAS INSERTED WITHOUT ISSUES. A DECISION WAS MADE TO USE FLUOROSCOPY BEFORE USING PROPER IMAGING TO STEER DOWN TO THE VALVE. HOWEVER, WHILE STEERING DOWN TO THE VALVE, THE CLIP UNINTENTIONALLY MOVED AND BECAME STUCK ON THE PATENT FORAMEN OVALE (PFO). TROUBLESHOOTING WAS PERFORMED TO REMOVE THE TIP OF THE CLIP OUT OF THE PFO BUT THE CLIP COULD NOT BE FREED. IN AN ATTEMPT TO REMOVE THE CLIP FROM THE PFO, THE CLIP WAS PULLED FOR 45 MINUTES. HOWEVER, THE CLIP HAD STARTED TO DETACH FROM THE MANDREL. THE CLIP WAS INVERTED. HOWEVER, THE CLIP COMPLETELY DETACHED FROM THE MANDREL, AND HUNG ON THE LOCK LINE. A DECISION WAS MADE TO REMOVE THE ENTIRE STEERABLE GUIDE CATHETER (SGC) ALL THE WAY BACK TO THE INCISION POINT. A VASCULAR SURGEON THEN MADE ANOTHER INCISION IN THE GROIN, AND WAS ABLE TO REMOVE THE CLIP, AND CLOSED THE GROIN. ONE CLIP WAS THEN INSERTED AND SUCCESSFULLY DEPLOYED ON THE TRICUSPID VALVE, REDUCING TR TO A GRADE OF 2-3. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22750252 ↗
• InjuryJul 11, 2025Incomplete Coaptation; Incomplete Coaptation

  ON (B)(6) 2025, A PATIENT WAS PRESENTED WITH GRADE 5 FUNCTIONAL TRICUSPID REGURGITATION(TR) FOR A TRICLIP PROCEDURE. DURING THE PROCEDURE, 3 TRICLIPS WERE SUCCESSFULLY IMPLANTED. THE TR GRADE WAS REDUCED TO 1 POST PROCEDURE. ON (B)(6) 2025, IT WAS OBSERVED ON FOLLOW UP CHECK UP THAT ONE TRICLIP HAD AN SINGLE LEAFLET DEVICE ATTACHMENT(SLDA) FROM SEPTAL LEAFLET. THE RECURRENT MR WAS OF GRADE 1-2. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 22480764 ↗
• InjuryJul 7, 2025Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2024, A TRICLIP PROCEDURE WAS PERFORMED TO TREAT FUNCTIONAL TRICUSPID REGURGITATION (TR) WITH A GRADE OF 5. TWO CLIPS WERE IMPLANTED, REDUCING TR TO A GRADE OF 1. AT THE ONE MONTH FOLLOW-UP APPOINTMENT, ECHOCARDIOGRAPHY SHOWED THE IMPLANTED CLIPS HAD DETACHED FROM THE SEPTAL LEAFLET (SINGLE LEAFLET DEVICE ATTACHMENT/SLDA), CAUSING TR TO INCREASE TO A GRADE OF 4.

  Patient problems: Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 22417374 ↗
• InjuryJul 7, 2025Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2024, A TRICLIP PROCEDURE WAS PERFORMED TO TREAT FUNCTIONAL TRICUSPID REGURGITATION (TR) WITH A GRADE OF 5. TWO CLIPS WERE IMPLANTED, REDUCING TR TO A GRADE OF 1. AT THE ONE MONTH FOLLOW-UP APPOINTMENT, ECHOCARDIOGRAPHY SHOWED THE IMPLANTED CLIPS HAD DETACHED FROM THE SEPTAL LEAFLET (SINGLE LEAFLET DEVICE ATTACHMENT/SLDA), CAUSING TR TO INCREASE TO A GRADE OF 4.

  Patient problems: Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 22416882 ↗
• MalfunctionJun 16, 2025Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2025, A PATIENT PRESENTED WITH GRADE 5 TRICUSPID REGURGITATION FOR A TRICLIP PROCEDURE. A TRICLIP WAS IMPLANTED SUCCESSFULLY. THE FINAL TR WAS GRADE 2. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS. ON (B)(6) 2025, DURING THE NEXT DAY FOLLOW-UP TESTING A TRANSTHORACIC ECHOCARDIOGRAM IT SHOWED THAT A SINGLE LEAFLET DETACHMENT (SLDA) HAD OCCURRED. THE CLIP WAS NO LONGER ATTACHED TO THE SEPTAL LEAFLET. THE TR WAS GRADE 3. THE PATIENT WAS EXPERIENCING NO EFFECTS AND WAS RELEASED FROM THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22214057 ↗
• MalfunctionJun 7, 2025Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED ON 14 MAY 2025 A PATIENT PRESENTED WITH GRADE 4 FUNCTIONAL TRICUSPID REGURGITATION (TR) AND A TETHERED SEPTAL LEAFLET FOR A TRICLIP PROCEDURE. REPORTEDLY, IMAGING WAS DIFFICULT. UPON DEPLOYMENT OF THE TRICLIP XT A SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) WAS OBSERVED. THE CLIP DETACHED FROM THE ANTERIOR LEAFLET AND REMAINED ATTACHED TO THE SEPTAL LEAFLET. THE TR GRADE REMAINED AT 4.

  Patient problems: Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 22162214 ↗
• InjuryJun 6, 2025Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Adverse Event Without Identified Device or Use Problem

  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, THE CLIP WAS INVERTED AND BECAME STUCK IN THE CHORDAE. TROUBLESHOOTING WAS PERFORMED TO REMOVE THE CLIP, DURING WHICH THE CHORDAE RUPTURED. THE CLIPS WERE REMOVED FROM THE PATIENT AND THE PROCEDURE WAS DISCONTINUED WITHOUT IMPLANTING ANY CLIPS. THE FINAL TR HAS WORSENED TO GRADE 5. THERE WAS NO ADDITIONAL INTERVENTION WAS PERFORMED FOR THE INJURY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22159809 ↗
• InjuryMay 30, 2025Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED ON (B)(6) 2025 A PATIENT PRESENTED WITH GRADE 4 TRICUSPID REGURGITATION (TR) AND A RESTRICTED SEPTAL LEAFLET FOR A TRICLIP PROCEDURE. IMAGING WAS CHALLENGING DUE TO THE PATIENT'S ANATOMY AND PACEMAKER LEAD. ONE TRICLIP WAS IMPLANTED. A SECOND TRICLIP XT WAS PLACED ON THE SEPTAL AND POSTERIOR LEAFLET SEGMENTS. POST-DEPLOYMENT A SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) WAS OBSERVED WITH THE SECOND CLIP. THE CLIP DETACHED FROM THE SEPTAL LEAFLET AND REMAINED ATTACHED TO THE POSTERIOR LEAFLET. A THIRD TRICLIP WAS DEPLOYED TO STABILIZE THE SECOND CLIP. THE FINAL TR GRADE WAS 2. PER THE PHYSICIAN THE SLDA WAS DUE TO POOR IMAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22114833 ↗
• MalfunctionMay 22, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED ON (B)(6) 2025 THAT THE PATIENT PRESENTED WITH GRADE 4+ FUNCTIONAL TRICUSPID REGURGITATION (TR). DURING THE PREPARATION OF TRICLIP XT, ONE GRIPPER WAS UNABLE TO LOWER. THERE WAS UNDESIRED GAP BETWEEN THE GRIPPER AND THE CLIP ARMS WHEN OPENED TO 120-140 DEGREES. TROUBLESHOOTING WAS PERFORMED AND WAS UNSUCCESSFUL. THERE WAS NO PATIENT INVOLVEMENT WITH THE COMPLAINT DEVICE. THE CLIP WAS REPLACED WITH ANOTHER DEVICE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22072543 ↗
• MalfunctionMay 20, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED A TRICLIP PROCEDURE WAS PERFORMED ON (B)(6) 2025 TO TREAT TRICUSPID REGURGITATION (TR). IT WAS LATER FOUND THAT THE CLIP HAD DETACHED FROM THE ANTERIOR LEAFLET RESULTING IN A SINGLE LEAFLET DEVICE ATTACHMENT (SLDA). A SECOND PROCEDURE WAS PERFORMED ON (B)(6) 2025. A CLIP WAS ADVANCED BUT DURING DEPLOYMENT THE GRIPPERS WOULD NOT COME DOWN. TROUBLESHOOTING WAS PERFORMED WITHOUT SUCCESS, SO THE CLIP WAS REMOVED FROM THE PATIENT. A DIFFERENT CLIP WAS PREPARED AND DEPLOYED REDUCING TR TO MODERATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22056884 ↗
• InjuryMay 16, 2025Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED ON (B)(6) 2025 A PATIENT PRESENTED WITH GRADE 4 FUNCTIONAL TRICUSPID REGURGITATION (TR) AND AN ENLARGED ATRIUM FOR A TRICLIP PROCEDURE. ONE TRICLIP XTW ON THE MID SEPTAL AND ANTERIOR LEAFLET SEGMENTS AND ONE TRICLIP XT WAS IMPLANTED ON THE CENTRAL SEPTAL AND ANTERIOR LEAFLET SEGMENTS. THE FINAL TR GRADE WAS 1-2. ON (B)(6) 2025 THE PATIENT PRESENTED WITH SYMPTOMATIC EPISODES OF NON-SUSTAINED VENTRICULAR TACHYCARDIA (NSVT). A TRANSTHORACIC ECHOCARDIOGRAM (TTE) WAS PERFORMED AND IT WAS NOTED THAT THE CLIPS WERE IN PLACE AND STABLE. AMIODARONE, MEXILETINE AND DIURETICS WERE ADMINISTERED. AN ELECTROPHYSIOLOGY CONSULTATION DETERMINED THE NSVT ORIGINATED FROM THE TRICUSPID VALVE ANNULUS. ON (B)(6) 2025 A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS PERFORMED AND TWO SINGLE LEAFLET DEVICE ATTACHMENTS (SLDA) WERE OBSERVED. BOTH CLIPS DETACHED FROM THE SEPTAL LEAFLET AND REMAINED ATTACHED TO THE ANTERIOR LEAFLET. ON THE TRANSGASTRIC, THE SEPTAL LEAFLET APPEARED SHORTER THAN PRE-PROCEDURE AND WAS SUSPECTED TO HAVE TORN. THE TR GRADE INCREASED TO 3-4. PER THE PHYSICIAN THE SLDA WAS DUE TO "FRIABLE LEAFLETS".

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

  MAUDE report 22036727 ↗