MitraClip™ CDS0706-NTWRecalls & reported problems

Summary

The FDA's MAUDE database contains 448 adverse event reports that list this exact device (DI 05415067037435), received between Nov 18, 2022 and May 21, 2026 — classified as 13 deaths, 253 injuries, 182 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 448 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2026Positioning Failure; Physical Resistance/Sticking

  IT WAS REPORTED ON 29 APRIL 2026 THAT THE PATIENT PRESENTED WITH GRADE 4 FUNCTIONAL MITRAL REGURGITATION (MR) FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO PERFORM TRANSEPTAL PUNCTURE. THE STEERABLE GUIDE CATHETER (SGC) WAS ADVANCED INTO LEFT ATRIUM, BUT WAS REMOVED DUE TO LOW TRANSEPTAL HEIGHT. UPON REMOVAL, THE SGC SHAFT WAS OBSERVED TO BE BENT. THE SGC WAS REPLACED WITH ANOTHER DEVICE TO COMPLETE THE PROCEDURE. DURING THE PROCEDURE, THE CLIP ADVANCED INSIDE ANATOMY WAS UNABLE TO STRAIGHTEN OR CURVE AS INTENDED, AS A RESULT, 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 REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25246300 ↗
• InjuryApr 28, 2026Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2024, A PATIENT PRESENTED WITH GRADE 4 DEGENERATIVE MITRAL REGURGITATION (MR) AND PROLAPSED LEAFLET FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, MITRACLIP WAS IMPLANTED. THE FINAL MR WAS GRADE 1. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED. ON (B)(6) 2026, IT WAS DETERMINED THAT THERE WAS A SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) AND THE CLIP WAS NO LONGER ATTACHED TO THE POSTERIOR LEAFLET AND HAD POSSIBLE TORN LEAFLET. MR RETURNED AFTER SLDA. ADDITIONAL NON-ABBOTT DEVICE WAS IMPLANTED ON THE SAME DAY.

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

  MAUDE report 25020991 ↗
• InjuryApr 7, 2026Migration

  N/A.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 24802128 ↗
• MalfunctionFeb 13, 2026Break; Difficult to Open or Close

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24335506 ↗
• MalfunctionFeb 4, 2026Retraction Problem; Unintended Movement; Physical Resistance/Sticking

  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, CLIP DELIVERY SYSTEM (CDS) HANDLE WAS NOT TRANSLATING TO CLIP. DELIVERY CATHETER SHAFT MOVED IN AN UNINTENDED WAY DURING ROTATION OF THE CDS HANDLE. DEVICE WAS REPLACED AND CONTINUED THE PROCEDURE. THE FINAL MR 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 24260766 ↗
• DeathJan 29, 2026Difficult or Delayed Positioning; Positioning Failure

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT PRESENTED WITH GRADE 4 FUNCTIONAL MITRAL REGURGITATION (MR) AND CONGESTIVE HEART FAILURE (CHF) FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, WHILE INDEPENDENTLY GRASPING THE LEAFLET, TEAR WAS OBSERVED. CLIP WAS NOT IMPLANTED, AND BALLOON PUMP WAS INSERTED AS A RESULT OF LEAFLET TEAR. PATIENT WAS HOSPITALIZED AND WAS IN INTENSIVE CARE UNIT (ICU). THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED. ON (B)(6) 2026, IT WAS REPORTED THAT THE PATIENT HAD DECEASED. IT WAS REPORTED THAT THE MITRACLIP CONTRIBUTED TO THE DEATH OF THE PATIENT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24214909 ↗
• InjuryJan 29, 2026Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2025, A PATIENT PRESENTED WITH GRADE 4 DEGENERATIVE MITRAL REGURGITATION (MR) AND PROLAPSED POSTERIOR LEAFLET FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, TWO MITRACLIPS WERE IMPLANTED. ALL STEPS WERE PERFORMED AS PER IFU. THE FINAL MR WAS GRADE <1. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED. ON (B)(6) 2025, IT WAS DETERMINED THAT A SINGLE LEAFLET DEVICE ATTACHMENT HAS OCCURRED FOR BOTH THE CLIPS AND CLIPS WERE NO LONGER ATTACHED TO THE POSTERIOR LEAFLET.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 24214696 ↗
• MalfunctionDec 17, 2025Positioning Failure; Difficult to Open or Close; Positioning Failure; Difficult to Open or Close

  IT WAS REPORTED THAT ON (B)(6) 2025, A PATIENT PRESENTED WITH GRADE 4 FUNCTIONAL MITRAL REGURGITATION (MR) FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, ONE OF THE GRIPPERS WOULD NOT LOWER AND THE PROCEDURE WAS DISCONTINUED. TROUBLESHOOTING WAS PERFORMED BUT WAS UNSUCCESSFUL. 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 23834809 ↗
• InjuryDec 9, 2025Difficult or Delayed Positioning; Deformation Due to Compressive Stress; Difficult to Open or Close; Difficult or Delayed Positioning; Deformation Due to Compressive Stress; Difficult to Open or Close

  IT WAS REPORTED ON 14 NOVEMBER 2025 THAT THE PATIENT PRESENTED WITH GRADE 4 FUNCTIONAL MITRAL REGURGITATION (MR) FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, CLIP WAS ADVANCED INTO VENTRICLE. THE GRIPPERS WERE ACCIDENTLY LOWERED BENEATH THE LEAFLETS. TROUBLESHOOTING WAS PERFORMED AND WAS SUCCESSFUL. THE CLIP WAS RETRACTED BACK INTO LEFT ATRIUM(LA). THE GRIPPER WAS OBSERVED TO BE BENT. AS A RESULT, A DECISION WAS MADE TO REMOVE THE CLIP FROM THE ANATOMY. WHILE REMOVAL, THE CLIP WAS UNABLE TO CLOSE COMPLETELY. THE ENTIRE SYSTEM WAS RETRACTED DOWN TO THE GROIN AND A SMALL INCISION WAS MADE TO ALLOW SMOOTH REMOVAL OF THE SYSTEM. THE MR REMAINED UNCHANGED POST PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY. ON (B)(6) 2025, THE HEMOSTASIS VALVE OF THE STEERABLE GUIDE CATHETER (SGC) WAS OBSERVED TO BE TORN ON RETURNED DEVICE ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23760349 ↗
• InjuryDec 5, 2025Leak/Splash; Leak/Splash

  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, AIR BUBBLE WAS OBSERVED IN THE SLEEVE OF DELIVERY CATHETER HANDLE WHILE ADVANCING INTO MITRAL VALVE. THE CLIP WAS REPLACED WITH ANOTHER DEVICE TO COMPLETE THE PROCEDURE. ADDITIONAL ANESTHETIC SUPPORT WAS PROVIDED TO THE PATIENT. THE MR WAS REDUCED TO GRADE 2+ POST PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY OR ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23729152 ↗
• MalfunctionNov 26, 2025Deformation Due to Compressive Stress; Difficult to Open or Close; Deformation Due to Compressive Stress; Difficult to Open or Close

  IT WAS REPORTED THAT ON (B)(6) 2025, A PATIENT PRESENTED WITH GRADE 4 DEGENERATIVE MITRAL REGURGITATION (MR), SHORT POSTERIOR LEAFLETS AND CALCIFIED ANTERIOR LEAFLETS FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, ONE OF THE GRIPPERS STOPPED RESPONDING DURING INDEPENDENT GRIPPER ACTUATION. TROUBLE SHOOTING WAS PERFORMED. THE CLIP WAS REMOVED FROM THE ANATOMY AND WAS OBSERVED AT THE BACK TABLE. UPON REMOVAL, A BENT WAS OBSERVED IN ONE GRIPPER. THE PROCEDURE WAS DISCONTINUED. ALL STEPS WERE PERFORMED AS PER IFU. THE FINAL MR REMAIN UNCHANGED POST PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED.

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

  MAUDE report 23662821 ↗
• MalfunctionNov 26, 2025Break; Difficult to Open or Close; Break; Difficult to Open or Close

  IT WAS REPORTED ON (B)(6) 2025 THAT THE PATIENT PRESENTED WITH GRADE 4 FUNCTIONAL MITRAL REGURGITATION (MR) FOR MITRACLIP PROCEDURE. DURING THE PROCEDURE, IT WAS OBSERVED THAT ANTERIOR GRIPPER WAS NOT RAISED OR LOWERED. THE ANTERIOR GRIPPER WAS ATTACHED TO ANTERIOR LEAFLET. THE DEVICE WAS MOVED BACK INTO THE ATRIUM, GRIPPERS WERE RECHECKED BUT IT WAS NOT FUNCTIONING. TROUBLE SHOOTING WAS PERFORMED BY LOCKING THE DEVICE AND CYCLING THE GRIPPERS. MITRACLIP WAS REMOVED AND IT WAS DETERMINED THAT GRIPPER LINE WAS NOT ATTACHED TO THE GRIPPER. ALL STEPS WERE PERFORMED AS PER IFU. NEW MITRACLIP WAS IMPLANTED SUCCESSFULLY. 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 23660502 ↗
• MalfunctionNov 14, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED ON (B)(6) 2025 THAT THE PATIENT PRESENTED WITH GRADE 3 FUNCTIONAL MITRAL REGURGITATION (MR), THICK SEPTUM, PREVIOUS CARDIAC SURGERY AND RESTRICTED POSTERIOR LEAFLET FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, DIFFICULTY WAS ENCOUNTERED WHILE PERFORMING TRANSEPTAL PUNCTURE. A BULGE WAS OBSERVED ON THE SEPTUM POSSIBLY DUE TO PREVIOUS CARDIAC SURGERY. AN ATTEMPT WAS MADE TO ADVANCE STEERABLE GUIDE CATHETER(SGC) INTO SEPTUM AND RESISTANCE WAS FELT. THE CLIP WAS INSERTED INTO SGC AND WAS OBSERVED UNDER FLUOROSCOPY AND ECHO GUIDANCE. IT WAS NOTED THAT SGC AND CLIP WERE NOT INSIDE THE SEPTUM. THE CLIP AND SGC WERE REMOVED FROM ANATOMY. UPON REMOVAL, VISUAL INSPECTION REVEALED DAMAGE TO THE POLYESTER COVERING OF THE CLIP. A NEW MITRACLIP NTW DEVICE WAS PREPARED. AN INTRA-AORTIC BALLOON PUMP WAS INSERTED TO FACILITATE SEPTAL DILATION. THE SGC WAS REINTRODUCED INTO THE ANATOMY, AND THE NTW CLIP WAS SUCCESSFULLY DEPLOYED. THE MR WAS REDUCED TO GRADE <1 POST PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23557299 ↗
• MalfunctionNov 6, 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. DURING THE PROCEDURE, POSTERIOR SIDE OF THE GRIPPER WOULD NOT LOWER COMPLETELY WHILE IN THE BODY. TROUBLESHOOTING WAS PERFORMED BY CYCLING THE LOCK LINE AND GRIPPER, THERE WAS NO CHANGE. THE CLIP WAS REMOVED FROM THE PATIENT AND ASSESSED IT. ALL STEPS WERE PERFORMED AS PER IFU. 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 23489762 ↗
• MalfunctionOct 30, 2025Retraction Problem; Failure to Advance; Expulsion; Material Split, Cut or Torn; Retraction Problem; Failure to Advance; Expulsion; Material Split, Cut or Torn

  IT WAS REPORTED THAT ON (B)(6) 2025, A PATIENT PRESENTED WITH GRADE 4+ FUNCTIONAL MITRAL REGURGITATION (MR) FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, THERE WERE CHALLENGES WITH REACHING THE LEAFLETS DUE TO A HIGH TRANSEPTAL PUNCTURE SO THE STEERABLE GUIDE CATHETER (SGC) AND A MITRACLIP WERE RETRACTED INTO THE LEFT ATRIUM AND THE TRANSSEPTAL WAS ATTEMPTED TO BE RE-PUNCTURED. WHEN THE CLIP WAS ATTEMPTED TO BE PULLED INTO THE GUIDE IT WAS IDENTIFIED THAT THE CLIP BECAME STUCK ON THE LIP OF THE GUIDE. TROUBLESHOOTING WAS PREFORMED BY ATTEMPTING TO PUSH THE CLIP OFF OF THE TIP OF THE GUIDE BUT IT REMAINED CAUGHT. DURING THIS TIME IT WAS IDENTIFIED THAT THE CLIP INTRODUCER WAS NO LONGER ATTACHED TO THE CLIP. THE CLIP AND THE SGC WERE FULLY REMOVED FROM THE PATIENT, WHILE RETRACTING THEM IT WAS OBSERVED THAT THE CLIP HAD FULLY DETACHED FROM THE INTRODUCER AND A HOLE WAS IDENTIFIED ON THE GUIDE WHERE THE CLIP HAD BEEN STUCK TO THE LIP OF THE GUIDE. THE SGC AND CLIP WERE FULLY REMOVED FROM THE PATIENT AND A NEW SGC AND MITRACLIP WERE ADVANCED THROUGH THE OPPOSITE FEMORAL VEIN, THE MITRACLIP WAS SUCCESSFULLY IMPLANTED AND THE PROCEDURE WAS DISCONTINUED. THE FINAL MR WAS GRADE 1+. THER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23430190 ↗
• DeathOct 30, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) WITH A GRADE OF 4 AND A MEAN PRESSURE GRADIENT OF 2MMHG. TWO MITRACLIP NTW CLIPS WERE INSERTED AND DEPLOYED ON THE MITRAL VALVE. A THIRD CLIP, A MITRACLIP NTW, WAS THEN INSERTED AND GRASPING WAS PERFORMED. HOWEVER, THE CLIP BECAME CAUGHT IN CHORDAE. TROUBLESHOOTING WAS PERFORMED, AND THE CLIP WAS ABLE TO BE REMOVED FROM THE CHORDAE. HOWEVER, WHILE BRINGING THE CLIP BACK INTO THE ATRIUM, IMAGING REVEALED A CHORDAL RUPTURE. THE CLIP WAS THEN BROUGHT BACK INTO THE VALVE, AND GRASPING WAS PERFORMED. THE CLIP WAS THEN DEPLOYED ON THE MITRAL VALVE. HOWEVER, THE MR WAS UNABLE TO BE REDUCED, AND THE GRADIENT HAD INCREASED TO 10MMHG. NO ADDITIONAL CLIPS WERE IMPLANTED DUE TO THE GRADIENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. HOWEVER, POST PROCEDURE, ON THE SAME DATE, THE PATIENT PASSED AWAY.

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

  MAUDE report 23423931 ↗
• InjuryOct 20, 2025Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THAT A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 4+ ON A PATIENT WITH THICKENED AND PROLAPSED ANTERIOR MITRAL LEAFLET (AML), RESTRICTED POSTERIOR MITRAL LEAFLET (PML). A MITRACLIP NTW WAS INSERTED AND DEPLOYED ON THE MITRAL VALVE. HOWEVER, DIFFICULTIES VISUALIZING THE CLIP OCCURRED, AND POST DEPLOYMENT, THE CLIP DETACHED FROM THE AML AND REMAINED ATTACHED TO THE PML (SINGLE LEAFLET DEVICE ATTACHMENT/SLDA). TO STABILIZE THE SLDA CLIP, A SECOND CLIP WAS IMPLANTED LATERALLY TO THE SLDA CLIP. TO FURTHER REDUCE MR, A THIRD CLIP WAS IMPLANTED LATERAL TO THE SECOND CLIP, REDUCING MR TO TRACE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PATIENT WAS REPORTED TO BE DISCHARGED ON THE FOLLOWING DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23336687 ↗
• MalfunctionOct 15, 2025Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED ON (B)(6) 2025 A PATIENT PRESENTED WITH GRADE 3+ FUNCTIONAL MITRAL REGURGITATION (MR), THIN LEAFLETS, AND A RESTRICTED POSTERIOR LEAFLET FOR A MITRACLIP PROCEDURE. THERE WAS DIFFICULTY VISUALIZING THE CLIP DURING THE PROCEDURE DUE TO THE PATIENT'S PRE-EXISITING HERNIA. ONE MITRACLIP NTW WAS PLACED. UPON DEPLOYMENT A SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) WAS OBSERVED. THE CLIP DETACHED FROM THE POSTERIOR LEAFLET AND REMAINED ATTACHED TO THE ANTERIOR LEAFLET. THE FINAL MR GRADE WAS 1+. THE PHYSICIAN BELIEVED THE SLDA WAS DUE TO THE PATIENT'S LEAFLET INTEGRITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23285993 ↗
• MalfunctionOct 15, 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, POSTERIOR GRIPPER WAS UNABLE TO ACTUATE DURING INDEPENDENT GRIPPER ACTUATION. 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 23285559 ↗
• InjuryOct 3, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED ON (B)(6) 2025 THAT THE PATIENT PRESENTED WITH GRADE 4 FUNCTIONAL MITRAL REGURGITATION (MR) AND TETHERED POSTERIOR LEAFLET FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, ONE MITRACLIP WAS IMPLANTED. DURING IMPLANTATION OF SECOND MITRACLIP, IMAGING WAS DIFFICULT DUE TO SHADOW FROM FIRST CLIP. A DIFFICULTY WAS ENCOUNTERED WHILE RELEASING THE CLIP. TROUBLESHOOTING WAS PERFORMED AND WAS SUCCESSFUL. WHILE RETRACTING BACK, A FLAIL OF ANTERIOR LEAFLET ALONG WITH INCREASED MR WAS OBSERVED. THE CLIP WAS REMOVED FROM THE ANATOMY. A NON-ABBOTT DEVICE WAS PLACED FOR STABILIZATION. THE MR REMAINED UNCHANGED POST PROCEDURE. PATIENT WAS IN STABLE CONDITION. THERE WAS NO CLINICALLY SIGNIFICANT DELAY.

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

  MAUDE report 23213463 ↗
• InjurySep 26, 2025Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED ON (B)(6) 2025 THAT THE PATIENT PRESENTED WITH GRADE 4 FUNCTIONAL MITRAL REGURGITATION (MR) AND RESTRICTED POSTERIOR LEAFLET FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, POST DEPLOYMENT OF MITRACLIP A SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) OCCURRED FROM POSTERIOR LEAFLET. ADDITIONAL MITRACLIP NTW WAS DEPLOYED TO STABILIZE THE SLDA CLIP AND REDUCTION OF MR TO GRADE 1-2. THERE WAS NO CLINICALLY SIGNIFICANT DELAY . NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23156733 ↗
• MalfunctionSep 10, 2025Incomplete Coaptation; Incomplete Coaptation

  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. THE FINAL MR WAS GRADE 1. ON (B)(6) 2025, IT WAS IDENTIFIED THROUGH A TRANSTHORACIC ECHOCARDIOGRAM (TTE) THAT A SINGLE LEAFLET DETACHMENT OCCURRED AND THE CLIP WAS NO LONGER ATTACHED TO A LEAFLET. THE FINAL MR INCREASED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23020561 ↗
• InjurySep 8, 2025Difficult or Delayed Positioning; Device Damaged by Another Device; Physical Resistance/Sticking; Difficult or Delayed Positioning; Device Damaged by Another Device; Physical Resistance/Sticking

  IT WAS REPORTED ON (B)(6) 2025 THAT THE PATIENT PRESENTED WITH GRADE 4+ FUNCTIONAL MITRAL REGURGITATION (MR) AND DILATED LEFT AND RIGHT VENTRICLE FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, ONE MITRACLIP WAS SUCCESSFULLY IMPLANTED. FOLLOWING DEPLOYMENT OF A SECOND MITRACLIP XTW, MITRAL REGURGITATION (MR) WORSENED. A THIRD MITRACLIP NTW WAS ATTEMPTED; HOWEVER, RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE CLIP LATERAL TO THE XTW. FLUOROSCOPY REVEALED ENTANGLEMENT BETWEEN THE NTW AND XTW CLIPS. DURING TROUBLESHOOTING, IT WAS OBSERVED THAT THE XTW GRIPPERS WERE NOT ENGAGED WITH THE LEAFLETS, AND ITS GRIPPER ASSEMBLY REMAINED INTACT WITH THE DISTAL END OF THE NTW, CONTRIBUTING TO THE ENTANGLEMENT. SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) OF THE XTW CLIP FROM THE ANTERIOR LEAFLET OCCURRED DURING THE DISENTANGLEMENT PROCESS. THE NTW CLIP WAS SUCCESSFULLY DEPLOYED WITH ADEQUATE LEAFLET GRASP. A ATRIAL SEPTAL DEFECT (ASD) HAD OCCURRED. PATIENT EXPERIENCED HYPOXIA. A NON-ABBOTT DEVICE WAS USED FOR ASD CLOSURE. THE PATIENT WAS PLACED ON INTRA-AORTIC BALLOON PUMP (IABP) SUPPORT IN INTENSIVE CARE UNIT (ICU). POST-PROCEDURE, MR WAS REDUCED TO GRADE 3+. THERE WAS NO CLINICALLY SIGNIFICANT P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22999064 ↗
• MalfunctionAug 29, 2025Difficult to Remove; Unintended Movement; Difficult to Remove; Unintended Movement

  IT WAS REPORTED ON (B)(6) 2025 THAT THE PATIENT PRESENTED WITH GRADE 4+ DEGENERATIVE MITRAL REGURGITATION (MR), HEART FAILURE AND FLAIL POSTERIOR LEAFLET FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, DIFFICULTY WAS ENCOUNTERED WHILE KEYING THE DEVICE. THE M KNOB WAS STEERING IN OPPOSITE DIRECTION WHEN IT WAS USED TO STEER IN DOWNWARD DIRECTION. THERE WAS UNUSUAL RESISTANCE EXPERIENCED WHILE REMOVAL OF CLIP DELIVERY SYSTEM FROM STEERABLE GUIDE CATHETER. 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. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22923480 ↗
• InjuryAug 26, 2025Incomplete Coaptation; Migration; Incomplete Coaptation; Migration

  IT WAS REPORTED THAT ON 04 AUGUST 2025, A PATIENT PRESENTED WITH GRADE 4 FUNCTIONAL MITRAL REGURGITATION (MR) AND AN ENLARGED ATRIUM FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, A MITRACLIP NTW WAS SUCCESSFULLY PLACED. AFTER DEPLOYMENT, THE CLIP SHIFTED ON THE POSTERIOR LEAFLETS. A SECOND MITRACLIP NT WAS SELECTED TO STABILIZE THE CLIP. IT WAS SUCCESSFULLY PLACED AND DEPLOYED. THE FINAL MR WAS GRADE 1-2. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS. NO ADDITIONAL INFORMATION WAS PROVIDED. ON AN APPROXIMATE DATE, (B)(6) 2025, THE PATIENT REPORTED BEING SYMPTOMATIC. ON AN APPROXIMATE DATE, (B)6) 2025, THE PATIENT RETURNED FOR A TRANSTHORACIC ECHOCARDIOGRAM WHEN IT WAS DISCOVERED THAT THE MITRACLIP NTW EXPERIENCED A SINGLE LEAFLET DETACHMENT (SLDA) AND WAS DETACHED FROM THE POSTERIOR LEAFLET AND THE MITRACLIP NT HAD AN SLDA AND WAS DETACHED FROM THE ANTERIOR LEAFLET. THE MR HAD WORSENED TO GRADE 4+. PER THE PHYSICIAN, THIS WAS LIKELY CAUSED BY FRIABLE LEAFLETS. THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY FOR ADDITIONAL TREATMENT. ON (B)(6) 2026, THE PATIENT UNDERWENT AN ADDITIONAL PROCEDURE WITH A NON-ABBOTT DEVICE TO STABILIZE THE SLDA CLIPS AND THE

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

  MAUDE report 22898417 ↗