MitraClip™ CDS0706-NTRecalls & reported problems

Summary

The FDA's MAUDE database contains 170 adverse event reports that list this exact device (DI 05415067037367), received between Nov 19, 2022 and Apr 7, 2026 — classified as 4 deaths, 100 injuries, 66 malfunctions.

The most frequently reported specific device problem is “Incomplete Coaptation” (41 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 170 reports, in the reporter's own words as published by the FDA.

• InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT PRESENTED WITH GRADE 4+ MIXED MITRAL REGURGITATION (MR) FOR A MITRACLIP PROCEDURE. IT WAS REPORTED THAT DURING DEVICE PREPARATION, IT WAS VISUALIZED THAT THE STEERABLE GUIDE CATHETER (SGC) TIP WAS AT AN IRREGULAR ANGLE. WHILE TESTING THE KNOB, THERE WAS IRREGULAR MOVEMENTS. WHILE REMOVING THE DILATOR FROM THE PATIENT THE DILATOR WAS DROPPED ON THE FLOOR. A REPLACEMENT SGC WAS ADVANCED AND MITRACLIP WAS SUCCESSFULLY PLACED. UPON DEPLOYMENT, THE CLIP MOVED ON THE POSTERIOR LEAFLET. A SECONDARY MITRACLIP WAS ATTEMPTED TO BE PLACED BUT WAS UNSUCCESSFUL DUE TO A TORN CHORDAE. THE PROCEDURE WAS DISCONTINUED; THE FINAL MR WAS GRADE 4+. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24802122 ↗
• InjuryFeb 13, 2026Difficult or Delayed Positioning

  IT WAS REPORTED THAT A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) WITH A GRADE OF 4 ON A PATIENT WITH FRIABLE TISSUE A MITRACLIP NT WAS INSERTED AND DEPLOYED ON THE MITRAL VALVE. TO FURTHER REDUCE MR, A SECOND CLIP, A MITRACLIP NT, WAS THEN INSERTED AND GRASPING WAS PERFORMED. A GOOD GRASP AND CAPTURED WAS ACHIEVED. HOWEVER, PRIOR TO DEPLOYMENT, A TRANSTHORACIC ECHOCARDIOGRAM (TTE) WAS PERFORMED AND REVEALED THAT THE ANTERIOR MITRAL LEAFLET (AML) HAD SLIPPED OUT OF THE CLIP, THAT THE MR HAD INCREASED, AND THE AML WAS OBSERVED TO BE DAMAGED. THEREFORE, THE CLIP WAS REPOSITIONED AND DEPLOYED CLOSER TO THE FIRST IMPLANTED CLIP. NO ADDITIONAL CLIPS WERE IMPLANTED, AND THE MR REMAINED AT A GRADE OF 4. THE CLIPS WERE NOTED TO BE STABLE ON THE LEAFLETS. THERE WERE NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

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

  MAUDE report 24335482 ↗
• MalfunctionFeb 4, 2026Difficult or Delayed Activation; Mechanical Jam

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT PRESENTED WITH GRADE 4 FUNCTIONAL MITRAL REGURGITATION (MR) FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, WHILE DEPLOYING THE CLIP, IT WAS UNABLE TO RELEASE THE CLIP FROM THE DELIVERY SYSTEM AS GRIPPER LINE WAS STUCK IN THE CLIP. TROUBLESHOOTING WAS PERFORMED AND WAS SUCCESSFUL. CLIP WAS IMPLANTED SUCCESSFULLY. ALL STEPS WERE PERFORMED AS PER IFU. THE FINAL MR WAS GRADE 4. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24260847 ↗
• InjuryJan 7, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, A PATIENT PRESENTED WITH GRADE 4 DEGENERATIVE MITRAL REGURGITATION (MR), THIN AND FLAIL LEAFLET AND MINIMAL HEIGHT FROM TRANSEPTAL FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, WHILE IMPLANTING THE MITRACLIP NT, LEAFLET TEAR WAS OBSERVED. MITRACLIP NT WAS REMOVED FROM THE PATIENT AND IMPLANTED ANOTHER CLIP. THE FINAL MR WAS GRADE 3. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED. ON (B)(6) 2025, MITRACLIP VALVE REPLACEMENT SURGERY WAS PERFORMED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23993732 ↗
• MalfunctionJan 6, 2026Difficult to Open or Close

  IT WAS REPORTED ON (B)(6) 2025 THAT THE PATIENT PRESENTED WITH FUNCTIONAL MITRAL REGURGITATION (MR) FOR A MITRACLIP PROCEDURE. DURING THE PREPARATION OF MITRACLIP, THE GRIPPER WAS UNABLE TO LOWER. THE ISSUE WAS PERSISTENT WITH THE SECOND CLIP AS WELL. TROUBLESHOOTING WAS PERFORMED AND WAS UNSUCCESSFUL. THE CLIP WAS REPLACED WITH ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY OR ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23973320 ↗
• MalfunctionJan 6, 2026Difficult to Open or Close

  IT WAS REPORTED ON (B)(6) 2025 THAT THE PATIENT PRESENTED WITH FUNCTIONAL MITRAL REGURGITATION (MR) FOR A MITRACLIP PROCEDURE. DURING THE PREPARATION OF MITRACLIP, THE GRIPPER WAS UNABLE TO LOWER. THE ISSUE WAS PERSISTENT WITH THE SECOND CLIP AS WELL. TROUBLESHOOTING WAS PERFORMED AND WAS UNSUCCESSFUL. THE CLIP WAS REPLACED WITH ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY OR ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23973319 ↗
• InjuryDec 23, 2025Incomplete Coaptation; Incomplete Coaptation

  N/A.

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

  MAUDE report 23885230 ↗
• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  N/A.

  Patient problems: High Blood Pressure/ Hypertension; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 23820910 ↗
• MalfunctionDec 8, 2025Difficult or Delayed Activation; Activation Failure; Difficult or Delayed Activation; Activation Failure

  IT WAS REPORTED ON (B)(6) 2025 THAT THE PATIENT PRESENTED WITH GRADE 4+ FUNCTIONAL MITRAL REGURGITATION (MR) FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, DIFFICULTY WAS ENCOUNTERED WHILE DEPLOYING THE CLIP AS THE TIP OF THE DELIVERY SYSTEM WAS UNABLE TO DETACH FROM THE CLIP. TROUBLESHOOTING WAS PERFORMED AND WAS UNSUCCESSFUL. THE CLIP WAS REPLACED WITH ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE MR 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 23747706 ↗
• InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, A PATIENT PRESENTED WITH GRADE 4+ DEGENERATIVE MITRAL REGURGITATION (MR) FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, TWO MITRACLIPS WERE SUCCESSFULLY IMPLANTED BEFORE THE PROCEDURE WAS DISCONTINUED. THE FINAL MR REMAINED UNCHANGED AT GRADE 4+. THERE WERE NO CLINICALLY SIGNIFICANT DELAYS REPORTED. ON (B)(6) 2025, THE PATIENT RETURNED FOR OPEN HEART SURGERY TO TREAT THE HIGH MR THROUGH A MITRAL VALVE REPLACEMENT PROCEDURE. THE PROCEDURE WAS SUCCESSFUL AND THE MR WAS REDUCED. ON (B)(6) 2026: THIS FILE (B)(4) - (B)(6) HAS BEEN IDENTIFIED AS A DUPLICATE, AS THE PART AND LOT NUMBER WERE IDENTICAL IN ADDITION TO THE REPORTED EVENT DETAILS TO (B)(4) - (B)(6). ALL PERTINENT AND ADDITIONAL INFORMATION WILL BE ADDED TO (B)(4).

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

  MAUDE report 23662841 ↗
• MalfunctionNov 26, 2025Difficult to Open or Close; Unintended Movement; Difficult to Open or Close; Unintended Movement

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23662347 ↗
• MalfunctionNov 26, 2025Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THAT A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 3, THIN LEAFLET, AND SHORT POSTERIOR LEAFLET. A MITRACLIP XTW WAS INSERTED AND DEPLOYED ON THE MITRAL VALVE. A SECOND CLIP, A MITRACLIP NT, WAS THEN INSERTED AND DEPLOYED ON THE MITRAL VALVE. HOWEVER, POST DEPLOYMENT, THE CLIP DETACHED FROM THE POSTERIOR LEAFLET AND REMAINED ATTACHED TO THE ANTERIOR LEAFLET (SINGLE LEAFLET DEVICE ATTACHMENT/SLDA). NO ADDITIONAL CLIPS WERE IMPLANTED, AND THE MR WAS DECREASED 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 23658084 ↗
• InjurySep 10, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT ON (B)(6) 2025, A PATIENT PRESENTED WITH GRADE 4+ FUNCTIONAL MITRAL REGURGITATION FOR A MITRACLIP PROCEDURE. A MITRACLIP XTW WAS SUCCESSFULLY IMPLANTED. THERE WAS A JET REMAINING IN THE MEDIAL COMMISSURE, A MITRACLIP NT WAS SELECTED. AFTER THE MITRACLIP NT WAS PREPARED, AND SUCCESSFULLY ADVANCED IT WAS ATTEMPTED TO BE PLACED. DURING GRASPING THE GRIPPERS WOULD NOT DESCEND, TROUBLESHOOTING WAS PERFORMED AND AFTER MULTIPLE ATTEMPTS THE GRIPPERS DID RESPONSE SUCCESSFULLY. THE MITRACLIP NT WAS THEN IMPLANTED SUCCESSFULLY. A SMALL FLAIL WAS IDENTIFIED ON THE ANTERIOR-3/POSTERIOR-3 (A3/P3) COMMISSURE, WHICH WAS LIKELY CAUSED BY THE CLIP. THE FINAL MR WAS GRADE 2+. THERE WAS NO CLINICALLY SIGNIFICANT DELAY REPORTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23020723 ↗
• InjuryJul 22, 2025Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2024, A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) WITH A GRADE OF 4 AND ENLARGED ATRIUM. TWO MITRACLIPS WERE DEPLOYED ON THE MITRAL VALVE, REDUCING MR TO A GRADE OF 1-2. ON (B)(6) 2025, DURING A TRICLIP PROCEDURE, AN ECHOCARDIOGRAM WAS PERFORMED AND REVEALED THAT ONE OF THE CLIPS HAD DETACHED FROM THE POSTERIOR LEAFLET AND REMAINED ATTACHED TO THE ANTERIOR LEAFLET (SINGLE LEAFLET DEVICE ATTACHMENT/SLDA), CAUSING MR TO INCREASE TO A GRADE OF 4.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 22568441 ↗
• MalfunctionJul 17, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THIS WAS A MITRACLIP PROCEDURE TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) WITH A GRADE OF 4. AN NT CLIP WAS INSERTED AND DEPLOYED ON THE MITRAL VALVE. HOWEVER, IMMEDIATELY AFTER DEPLOYMENT, THE CLIP OPENED FROM 10 DEGREES TO ROUGHLY 40 DEGREES. IT WAS NOTED THE CLIP REMAINED STABLE ON THE LEAFLETS AND MR WAS REDUCED TO 1-2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22532161 ↗
• MalfunctionJul 14, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THIS WAS A MITRACLIP PROCEDURE TO TREAT FUNCTIONAL MITRAL REGURGITATION WITH A GRADE OF 3-4. ONE CLIP WAS SUCCESSFULLY IMPLANTED. TO FURTHER REDUCE MR, AN ADDITIONAL CLIP WAS INSERTED AND PLACED ON THE MITRAL VALVE. WHILE ATTEMPTING TO DEPLOY THE CLIP, THE LOCK LINE WAS UNABLE TO BE REMOVED. THE CLIP WAS ABLE TO BE UNLOCKED AND REMOVED. THE PROCEDURE WAS DISCONTINUED. MR 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 22500990 ↗
• InjuryJun 27, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED ON (B)(6) 2025 THAT THE PATIENT PRESENTED WITH GRADE 4+ DEGENERATIVE MITRAL REGURGITATION (MR) AND ENLARGED ATRIUM FOR A MITRACLIP PROCEDURE. MITRACLIP 41002A1070 NTW WAS IMPLANTED SUCCESSFULLY. DURING DEPLOYMENT SECOND MITRACLIP 40903R1098 NT, DIFFICULTY GRASPING THE LEAFLETS WAS ENCOUNTERED. THERE WAS CHORDAL RUPTURE WHICH LEAD TO INCREASE IN MR. THE DEVICE WAS REMOVED FROM THE ANATOMY. THIRD MITRACLIP 50113A1026 XTW WAS PLACED MEDIAL TO CLIP 1. THE CLIP WAS STABLE ON DEPLOYMENT. FOURTH MITRACLIP 50115A1041 XTW WAS PLACED MEDIAL TO CLIP 1 AND LATERAL TO CLIP 2. AN ATTEMPT WAS MADE TO PLACE THE FIFTH MITRACLIP 50123R1008 XTW LATERAL TO CLIP 4 AND MEDIAL TO CLIP 1. FIFTH CLIP WAS ENTANGLED WITH CLIP 4 AND CAUSED IT TO SHIFT. THERE WAS INADEQUATE GRASP OF LEAFLETS WHICH LEAD TO UNCHANGED MR. THE FIFTH CLIP WAS REMOVED FROM ANATOMY. AN ATTEMPT WAS MADE TO IMPLANT A CLOSURE DEVICE BETWEEN FIRST AND THIRD MITRACLIP. DURING DEPLOYMENT OF CLOSURE DEVICE, IT HAD INTERACTION WITH MITRACLIP 1. THIS MADE MITRACLIP 1 TO SHIFT AND LEAD TO INCREASE IN MR TO GRADE 4+. THE PATIENT WAS EXTUBATED AND WAS IN STABLE CONDITION. THE PHYSICIAN REFERRED THE PATIENT FOR SURGERY. THERE WAS

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22347001 ↗
• InjuryJun 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, A PATIENT PRESENTED WITH GRADE 4 DEGENERATIVE MITRAL REGURGITATION, A POSTERIOR CALCIUM SHELF WITH SHORT RESTRICTED POSTERIOR LEAFLET AND ELEVATED STARTING GRADIENT FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE THERE WAS CHALLENGES IN REDUCING THE MR. A MITRACLIP XTW AND A MITRACLIP NT WERE ATTEMPTED BUT WERE NOT IMPLANTED. DURING THE GRASPING ATTEMPTS, THERE WAS A TISSUE PERFORATION NOTED ON THE POSTERIOR LEAFLET. PER THE PHYSICIAN, THERE WERE NO DEVICE MALFUNCTIONS. THE FINAL MR WAS GRADE 3-4. THERE WERE NO CLINICALLY SIGNIFICANT DELAYS REPORTED. AN ADDITIONAL MEDICAL PROCEDURE HAS BEEN SCHEDULED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22237855 ↗
• MalfunctionJun 2, 2025Material Separation; Difficult to Open or Close; Material Separation; Difficult to Open or Close

  IT WAS REPORTED ON (B)(6) 2025, THAT THE PATIENT PRESENTED WITH GRADE 4 DEGENERATIVE MITRAL REGURGITATION (MR) PROLAPSED POSTERIOR LEAFLET AND MITRAL ANNULAR CALCIFICATION (MAC)ANTERIOR LEAFLET CALCIFICATION (NOT IN GRASPING ZONE) FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE OF MITRACLIP THE CLIP WAS STEERED DOWN TO THE VALVE BUT THE INITIAL GRASP ATTEMPT DID NOT ADEQUATELY REDUCE MITRAL REGURGITATION (MR). ECHOCARDIOGRAPHY (ECHO) REVEALED THAT THE ANTERIOR LEAFLET GRIPPER WAS UNABLE TO RAISE WHEN AN ATTEMPT WAS MADE TO RAISE BOTH THE GRIPPERS. FURTHER INSPECTION WITH ECHO AND FLUOROSCOPY CONFIRMED THE ANTERIOR GRIPPER REMAINED DOWN WHEN THE LEVER WAS RETRACTED. THE CLIP WAS RETRACTED INTO THE GUIDE, REVEALING THE GRIPPER LINE WAS DETACHED FROM THE GRIPPER. THE CLIP WAS REPLACED WITH ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE MR WAS DECREASED TO GRADE 3-4 POST PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22126485 ↗
• MalfunctionMay 23, 2025Break; Material Separation; Difficult to Open or Close; Break; Material Separation; Difficult to Open or Close

  IT WAS REPORTED THAT ON (B)(6) 2025, A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) GRADE 4. A NT MITRACLIP WAS CHOSEN FOR IMPLANTATION. "+" KNOB WAS APPLIED TO THE STEERABLE GUIDE CATHETER AND BOTH THE ANTERIOR AND MEDIAL KNOBS WERE APPLIED TO THE CLIP DELIVERY SYSTEM. WHEN MAKING THE THIRD GRASP ATTEMPT, IT WAS NOTED THAT THE GRIPPERS WERE NO LONGER MOVING. THEY WERE IN LOWERED POSITION AND WOULD NOT RAISE. TROUBLESHOOTING WAS PERFORMED. THE CLIP WAS ABLE TO BE REMOVED AND A REPLACEMENT DEVICE WAS IMPLANTED WITHOUT ISSUE. OUTSIDE THE PATIENT THE GRIPPER LINES WERE OBSERVED TO BE DETACHED. THERE WERE NO PATIENT CONSEQUENCES OR CLINICALLY SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22078760 ↗
• MalfunctionMay 16, 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 MITRAL REGURGITATION (MR) FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, ACTIVATED CLOTTING TIME (ACT) WAS MAINTAINED AT 385 SECONDS. AFTER TRANSEPTAL PUNCTURE A NON-ABBOTT WIRE WAS ACCESSED ACROSS SEPTUM INTO LEFT ATRIUM. AS STEERABLE GUIDE CATHTER (SGC) WAS BEING ADVANCED, THROMBUS WAS OBSERVED ON THE WIRE IN THE RIGHT ATRIUM. 3000 UNITS OF HEPARIN WAS ADMINISTERED. SGC WAS REMOVED WITH NO ADVERSE EVENT. 26F GORE DRY SEAL WAS PLACED AND CLOT WAS SUCCESSFULLY REMOVED WITH NEGATIVE SUCTION. SGC FLUSHED AND RE-ENTERED INTO BODY. SGC DID NOT CAUSE THROMBUS FORMATION, MIGRATION FROM ITS ORIGINAL LOCATION, OR WORSENING OF THE THROMBUS. DURING THE PROCEDURE, GRIPPER ORIENTATION WAS PERFORMED AND WAS SUCCESSFUL. MITRACLIP NTW ADVANCED INTO LEFT ATRIUM(LA) AND DURING INDEPENDENT GRIPPER CHECK IT WAS NOTED THAT THE ANTERIOR GRIPPER WAS UNABLE TO LOWER AND RAISE. TROUBLESHOOTING WAS PERFORMED AND WAS UNSUCCESSFUL. THE CLIP WAS REPLACED WITH ANOTHER NTW CLIP TO COMPLETE THE PROCEDURE. AFTER DEPLOYMENT OF MITRACLIP NTW ON LATERAL SIDE, A RESIDUAL JET AND MITRAL PRESSURE GRADIENT OF 5 MMHG WAS NOTED. AN ATTEMPT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22038024 ↗
• MalfunctionMay 16, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 4, PROLAPSED ANTERIOR LEAFLET, AND FLAIL. A MITRACLIP XTW WAS INSERTED AND DEPLOYED ON THE MITRAL VALVE. A SECOND CLIP, A MITRACLIP NT, WAS PREPARED PER THE INSTRUCTIONS FOR USE (IFU), INSERTED WITHOUT ISSUES, AND POSITIONED LATERAL TO THE FIRST CLIP. HOWEVER, DIFFICULTIES VISUALIZING THE CLIP OCCURRED, AND ONE OF THE GRIPPERS WOULD NOT LOWER. TROUBLESHOOTING WAS PERFORMED, BUT THE ISSUE WAS UNABLE TO BE RESOLVED. THEREFORE, THE CLIP WAS REMOVED FROM THE PATIENT. NO ADDITIONAL CLIPS WERE IMPLANTED, AND MR WAS REDUCED TO A GRADE OF 3. WHILE OUTSIDE THE PATIENT, THE GRIPPER FUNCTION WAS TESTED, BUT ONE OF THE GRIPPERS DID NOT LOWER. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22036193 ↗
• InjuryMay 13, 2025Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THIS WAS A MITRACLIP PROCEDURE TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 4. ONE CLIP WAS PLACED WITHOUT ISSUE. A SECOND CLIP WAS ADVANCED INTO THE PATIENT ANATOMY AND DEPLOYED ON BOTH LEAFLETS. HOWEVER, AFTER DEPLOYMENT THE CLIP DETACHED FROM THE POSTERIOR LEAFLET AND REMAINED ATTACHED ONLY TO THE ANTERIOR LEAFLET IN A SINGLE LEAFLET DEVICE ATTACHMENT (SLDA). IT WAS ALSO NOTED THAT THE POSTERIOR LEAFLET HAD BEEN DAMAGED. NO ADDITIONAL INTERVENTION WAS PERFORMED, AND MR WAS REDUCED TO GRADE 2.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22013532 ↗
• InjuryApr 4, 2025Incomplete Coaptation; Incomplete Coaptation

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21778349 ↗
• MalfunctionMar 17, 2025Difficult to Advance; Difficult to Open or Close; Unintended Movement; Difficult to Advance; Difficult to Open or Close; Unintended Movement

  IT WAS REPORTED THAT A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 3. A MITRACLIP NT WAS PREPARED PER THE INSTRUCTIONS FOR USE IFU). HOWEVER, WHILE THE MITRACLIP NT WAS EXITING THE STEERABLE GUIDE CATHETER (SGC) AND ADVANCING TO STRADDLE, RESISTANCE WAS ENCOUNTERED. MINOR ADVANCING WAS APPLIED, AND THE SLEEVE JUMPED FORWARD TOWARDS THE STRADDLE POSITION INTO THE LEFT ATRIUM (LA). THE CLIP WAS STEERED DOWN TO THE VALVE WITHOUT FURTHER INCIDENT. THE CLIP WAS DEPLOYED ON THE MITRAL VALVE, REDUCING MR 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 21620581 ↗