MitraClip™ CDS0706-XTRecalls & reported problems

Summary

The FDA's MAUDE database contains 282 adverse event reports that list this exact device (DI 05415067037404), received between Nov 15, 2022 and Jun 29, 2026 — classified as 7 deaths, 152 injuries, 123 malfunctions.

The most frequently reported specific device problem is “Incomplete Coaptation” (73 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 282 reports, in the reporter's own words as published by the FDA.

• DeathJun 29, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2026, A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) WITH A GRADE OF 4+. THE PATIENT HAD A HISTORY OF HEART AND ORGAN FAILURE. AN XTW CLIP WAS SUCCESSFULLY IMPLANTED. TO FURTHER REDUCE MR, AN XT CLIP WAS DEPLOYED. HOWEVER, AFTER DEPLOYMENT, A JET WAS OBSERVED COMING THROUGH THE ANTERIOR LEAFLET. AN ABBOTT PFO CLOSURE DEVICE WAS USED TO TREAT THE JET. MR WAS REDUCED TO A GRADE OF <1. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE FOLLOWING MORNING, THE MR REMAINED AT <1 AND THE PATIENT WAS DISCHARGED. ON AN UNKNOWN DATE, THE PATIENT RETURNED TO THE HOSPITAL DUE TO SHORTNESS OF BREATH. THE PHYSICIAN DETERMINED IT WAS DUE TO HEART AND ORGAN FAILURE. ON (B)(6) 2026, THE PATIENT PASSED AWAY. THE ABBOTT DEVICES REMAINED STABLE.

  Patient problems: Dyspnea; Heart Failure/Congestive Heart Failure

  MAUDE report 25659755 ↗
• MalfunctionMar 24, 2026Difficult to Open or Close

  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, A MITRACLIP XT WAS ACTUATING SUCCESSFULLY. AFTER A FEW GRASPING ATTEMPTS, ONE OF THE GRIPPERS WOULD NO LONGER DESCEND. TROUBLESHOOTING WAS PREFORMED UNSUCCESSFULLY AND THE GRIPPER WOULD NOT DESCEND. THE CLIP WAS REMOVED FROM THE PATIENT AND A NEW MITRACLIP XT WAS SUCCESSFULLY IMPLANTED. THE PROCEDURE WAS DISCONTINUED, THE FINAL MR 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 24677227 ↗
• MalfunctionMar 24, 2026Unintended Movement

  IT WAS REPORTED ON (B)(6) 2026 THAT THE PATIENT PRESENTED WITH GRADE 4+ FUNCTIONAL MITRAL REGURGITATION (MR) FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, A MITRACLIP WAS SUCCESSFULLY IMPLANTED AT ANTERIOR AND POSTERIOR LEAFLET 2(A2P2). DURING THE DEPLOYMENT SEQUENCE OF SECOND MITRACLIP, THE CLIP WAS OBSERVED TO BE OPEN AFTER RELEASING PIN. THE MR WAS REDUCED TO GRADE 3+ POST PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY OR ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24674644 ↗
• DeathMar 6, 2026Difficult or Delayed Positioning; Positioning Failure

  IT WAS REPORTED ON (B)(6) 2026, THAT THE PATIENT PRESENTED WITH GRADE 4 MIXED MITRAL REGURGITATION (MR), MODERATE-TO-SEVERE AORTIC STENOSIS, CHRONIC HEART FAILURE WITH PRESERVED EJECTION FRACTION (HFPEF), HYPERTENSION, AND A SCHATZKI¿S RING FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, IMAGING WAS CHALLENGING. IN AN ATTEMPT TO IMPROVE IMAGING QUALITY, A PRESSURE BAG WAS POSITIONED UNDER THE PATIENT'S SHOULDER. A MITRACLIP WAS SUBSEQUENTLY SUCCESSFULLY IMPLANTED. AN ATTEMPT WAS THEN MADE TO DEPLOY A SECOND MITRACLIP. MULTIPLE LEAFLET GRASPING AND CAPTURE ATTEMPTS WERE PERFORMED BUT WERE UNSUCCESSFUL. THE CLIP WAS RETRACTED INTO THE LEFT ATRIUM, AT WHICH TIME A NEW FLAIL SEGMENT WAS VISUALIZED. THE SECOND CLIP WAS REORIENTED, ADVANCED INTO THE LEFT VENTRICLE, AND SUCCESSFULLY DEPLOYED. POST-PROCEDURE, THE MR WAS REDUCED TO GRADE 3¿4; HOWEVER, THE MEAN MITRAL PRESSURE GRADIENT INCREASED TO 7 MMHG. ON (B)(6) 2026, THE PATIENT WAS REPORTED TO BE DECEASED. SEVERE MR WITH ACUTE ON CHRONIC HEART FAILURE WITH PRESERVED EJECTION FRACTION, LEADING TO CARDIOGENIC SHOCK AND HEMODYNAMIC INSTABILITY, CONTRIBUTED TO THE PATIENT'S DEATH. THERE WAS NO CLINICALLY SIGNIFICANT DELAY REPORTED.

  Patient problems: Mitral Valve Stenosis; Unspecified Tissue Injury

  MAUDE report 24533345 ↗
• InjuryFeb 27, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2026 THAT THE PATIENT PRESENTED WITH GRADE 3-4 MITRAL REGURGITATION (MR) FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, DIFFICULTY WAS ENCOUNTERED WHILE PERFORMING TRANSEPTAL PUNCTURE. BRADYCARDIA AND HYPOTENSION WAS OBSERVED WHILE POSITIONING THE CLIP. ECHOCARDIOGRAPHY REVEALED SMALL PERICARDIAL EFFUSION(PE). THE CLIP WAS REMOVED FROM THE ANATOMY. A PERICARDIOCENTESIS WAS PERFORMED TO TREAT PE. THE PROCEDURE WAS TERMINATED WITH UNCHANGED MR. THERE WAS NO CLINICALLY SIGNIFICANT DELAY.

  Patient problems: Bradycardia; Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 24471078 ↗
• MalfunctionFeb 20, 2026Device Damaged by Another Device

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24402856 ↗
• MalfunctionJan 29, 2026Unstable; Unintended Movement

  IT WAS REPORTED ON 06 JANUARY 2026 THAT THE PATIENT PRESENTED WITH GRADE 4 DEGENERATIVE MITRAL REGURGITATION (MR) AND PROLAPSED LEAFLET FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, THE CLIP WAS UNABLE TO PASS ESTABLISH FINAL ARM ANGLE TEST (EFAA). THE ARM POSITIONER FELT UNSTABLE. THE CLIP WAS REMOVED FROM THE ANATOMY. THE CLIP WAS REPLACED WITH ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THE MR WAS REDUCED TO GRADE 1-2 POST PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY OR ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24210848 ↗
• MalfunctionJan 12, 2026Unintended Movement; Physical Resistance/Sticking

  IT WAS REPORTED THAT A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) WITH A GRADE OF 3-4. A MITRACLIP XTW WAS INSERTED AND DEPLOYED ON THE MITRAL VALVE. A SECOND CLIP, A MITRACLIP XT, WAS THEN INSERTED AND PLACED ON THE MITRAL VALVE. HOWEVER, WHILE ATTEMPTING TO DEPLOY THE CLIP, THE LOCK LINE FAILED. THEREFORE, THE CLIP WAS REMOVED AND REPLACED. ONE CLIP WAS THEN INSERTED AND DEPLOYED ON THE MITRAL VALVE, REDUCING MR TO A GRADE OF 1-2. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24036875 ↗
• InjuryJan 9, 2026Incomplete Coaptation

  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, A MITRACLIP WAS SUCCESSFULLY IMPLANTED AT MEDIAL ANTERIOR AND POSTERIOR LEAFLET 2 (A2P2). POST DEPLOYMENT, THE CLIP HAD SINGLE LEAFLET DEVICE ATTACHMENT(SLDA) FROM THE POSTERIOR LEAFLET. AN ATTEMPT WAS MADE TO DEPLOY SECOND MITRACLIP BUT DUE TO HIGH MITRAL PRESSURE GRADIENT, THE CLIP WAS REMOVED FROM THE ANATOMY. THE MR WAS REDUCED TO GRADE 2 POST PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24020134 ↗
• MalfunctionDec 29, 2025Incomplete Coaptation; Incomplete Coaptation

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23908627 ↗
• InjuryDec 26, 2025Unintended Movement; Unintended Movement

  N/A.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 23896227 ↗
• MalfunctionDec 15, 2025Difficult or Delayed Positioning; Incomplete Coaptation; Difficult or Delayed Positioning; Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2025, A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) GRADE 4+. THE PATIENT HAD A PRE-EXISTING NON-ABBOTT LEFT ATRIAL APPENDAGE OCCLUSION DEVICE AND A PRE-EXISTING AMPLATZER SEPTAL OCCLUSION DEVICE. AFTER SEVERAL ATTEMPTS, A TRANSEPTAL PUNCTURE WAS ACHIEVED POSTERIOR TO THE AMPLATZER, WITH THE PUNCTURE HEIGHT MEASURED AT 4.3 CM ABOVE THE VALVE PLANE. FOLLOWING THIS, THE SGC AND CDS WERE INTRODUCED, AND ADDITIONAL HEIGHT WAS REQUIRED TO ACHIEVE PERPENDICULARITY TO THE MITRAL VALVE; THIS WAS ACCOMPLISHED USING THE POSTERIOR (P) KNOB AND ADJUSTMENTS TO THE MEDIAL (M) KNOB TO ADEQUATELY POSITION THE CLIP ABOVE THE LEAFLET LEVEL. ONCE PROPER ARM ORIENTATION WAS CONFIRMED USING 3D EN FACE AND LVOT VIEWS, A FIRST CLIP WAS SUCCESSFULLY GRASPED AND DEPLOYED ON THE MEDIAL A2/P2 SEGMENT, REDUCING THE MITRAL REGURGITATION FROM 4+ TO 3+ WITH A MEAN GRADIENT OF 2 MMHG AND REDUCTION OF THE V-WAVE TO 40 MMHG. BECAUSE RESIDUAL LATERAL MR PERSISTED, THE TEAM PROCEEDED WITH A SECOND XTW CLIP POSITIONED LATERAL TO THE FIRST. ALTHOUGH LEAFLET GRASPING AND ASSESSMENT WERE SATISFACTORY, THE SECOND CLIP ENCOUNTERED DEPLOYMENT DIFFICULTIES RE

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 23811900 ↗
• DeathDec 15, 2025Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2025 A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) WITH A GRADE OF 4+, AN ENLARGED ATRIUM, DILATED ANNULUS, AND A 6CM2 MITRAL VALVE AREA ON A PATIENT WITH A MEDICAL HISTORY OF HEART FAILURE (HF), RENAL DISEASE, CORONARY ARTERY DISEASE (CAD). TWO MITRACLIP XTW CLIPS WERE INSERTED AND DEPLOYED ON THE MITRAL VALVE WITHOUT ISSUES. A THIRD CLIP, A MITRACLIP XT (50304A1041), WAS THEN INSERTED AND DEPLOYED ON THE MITRAL VALVE. HOWEVER, POST DEPLOYMENT, IMAGING REVEALED CHORDAL RUPTURE AND THAT THE CLIP HAD DETACHED FROM THE POSTERIOR MITRAL LEAFLET (PML) AND REMAINED ATTACHED TO THE ANTERIOR MITRAL LEAFLET (AML) (SINGLE LEAFLET DEVICE ATTACHMENT/SLDA). TO STABILIZE THE CLIP, A FOURTH CLIP, A MITRACLIP NTW (50313A2091), WAS INSERTED, AND GRASPING WAS PERFORMED. HOWEVER, DIFFICULTIES GRASPING AND CAPTURING THE LEAFLETS OCCURRED. THEREFORE, THE CLIP WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS DISCONTINUED, AND THE MR WAS REDUCED TO A GRADE OF 3+. ON (B)(6) 2025, THE PATIENT DIED DUE TO HEART FAILURE (HF) AND SEVERE MR. IT WAS NOTED THAT THE CLIPS WERE STABLE ON THE LEAFLETS. SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDI

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

  MAUDE report 23811897 ↗
• InjuryDec 12, 2025Difficult or Delayed Positioning; Entrapment of Device; Incomplete Coaptation; Difficult or Delayed Positioning; Entrapment of Device; Incomplete Coaptation

  IT WAS REPORTED THAT A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 4 AND FRIABLE LEAFLETS. A MITRACLIP XTW WAS INSERTED AND DEPLOYED ON THE MITRAL VALVE. TO FURTHER REDUCE MR, A MITRACLIP XT WAS INSERTED, BUT AFTER SEVERAL GRASPING ATTEMPTS, THE MR WORSENED, AND IT WAS OBSERVED THAT THE POSTERIOR LEAFLET WAS TORN. A DECISION WAS MADE TO MOVE CLOSER TO THE FIRST CLIP, BUT THE CLIP APPEARED TO BE STUCK, AND WAS UNABLE TO BE RETRACTED TO THE LEFT ATRIUM (LA). THEREFORE, THE CLIP WAS DEPLOYED WHERE IT WAS STUCK, ATTACHED TO ONLY THE ANTERIOR LEAFLET. AFTER DEPLOYMENT, IT WAS OBSERVED THAT THE CLIP HAD ONLY BEEN ATTACHED TO THE ANTERIOR LEAFLET AND DETACHED FROM THE POSTERIOR LEAFLET (SINGLE LEAFLET DEVICE ATTACHMENT/SLDA). THE CLIP DELIVERY SYSTEM (CDS) WAS REMOVED FROM THE PATIENT. NO ADDITIONAL CLIPS WERE IMPLANTED, AND THE MR REMAINED AT A GRADE OF 4. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

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

  MAUDE report 23794958 ↗
• MalfunctionDec 5, 2025Improper or Incorrect Procedure or Method; Physical Resistance/Sticking; Improper or Incorrect Procedure or Method; Physical Resistance/Sticking

  IT WAS REPORTED ON (B)(6) 2025 THAT THE PATIENT PRESENTED WITH GRADE 4+ DEGENERATIVE MITRAL REGURGITATION (MR) FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, LOCK LINE WAS SEIZED IN CLIP DELIVERY SYSTEM SHAFT. THE LOCK LINE WAS REMOVED ALONG WITH THE CLIP DELIVERY SYSTEM. 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 23729153 ↗
• InjuryDec 5, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED ON (B)(6) 2025 THAT THE PATIENT PRESENTED WITH GRADE 4+ FUNCTIONAL MITRAL REGURGITATION (MR) AND RESTRICTED LEAFLETS FOR A MITRACLIP PROCEDURE. DURING PREPARATION OF THE STEERABLE GUIDE CATHETER (SGC), THE FLUSH PORT OF DILATOR BROKE WHILE TIGHTENING THE STOPCOCK TO THE FLUSH PORT. THE SGC WAS REPLACED WITH ANOTHER DEVICE TO COMPLETE THE PROCEDURE. DURING THE PROCEDURE, A MITRACLIP XTW WAS INSERTED INTO THE ANATOMY BUT REMOVED AFTER A JET WAS OBSERVED LATERAL TO THE ANTERIOR AND POSTERIOR LEAFLET AT ANTERIOR AND POSTERIOR LEAFLET 2 (A2P2). A MITRACLIP XT WAS THEN INSERTED BUT REMOVED DUE TO A FLAIL LEAFLET CAUSED BY MULTIPLE GRASPING ATTEMPTS. FINALLY, A MITRACLIP XTW WAS SUCCESSFULLY DEPLOYED AT THE LATERAL A2P2 SEGMENT. THE MR WAS REDUCED TO GRADE 2+ POST PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23729102 ↗
• MalfunctionDec 5, 2025Unintended Movement; Unintended Movement

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23728155 ↗
• InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  N/A.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 23662851 ↗
• InjuryNov 21, 2025Entrapment of Device; Entrapment of Device

  IT WAS REPORTED ON (B)(6) 2025 THAT THE PATIENT PRESENTED WITH GRADE 4+ FUNCTIONAL MITRAL REGURGITATION (MR), MITRAL ANNULAR CALCIFICATION AND RESTRICTED POSTERIOR LEAFLET FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, IMAGING WAS DIFFICULT. THE CLIP WAS ENTANGLED WITH CHORDAE DURING CAPTURING THE LEAFLETS. TROUBLESHOOTING WAS PERFORMED AND WAS UNSUCCESSFUL. AS A RESULT, THE CLIP WAS DEPLOYED ON THE CHORDAE WITHOUT LEAFLETS. PERICARDIAL EFFUSION WAS NOTED AFTER AN HOUR OF TRANSEPTAL PUNCTURE AND PERICARDIOCENTESIS WAS PERFORMED. PATIENT IS IN STABLE CONDITION. THE MR REMAINED UNCHANGED POST PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY.

  Patient problems: Foreign Body In Patient; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 23619110 ↗
• InjuryNov 5, 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 MITRACLIP PROCEDURE WAS PERFORMED TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) WITH A GRADE OF 4 AND A MEAN PRESSURE GRADIENT OF 1 ON A PATIENT WITH A MEDICAL HISTORY OF HEART FAILURE. A MITRACLIP XTW WAS INSERTED AND DEPLOYED ON THE MITRAL VALVE. A MITRACLIP XT WAS THEN IMPLANTED, REDUCING MR TO A GRADE OF 2. HOWEVER, THE GRADIENT INCREASED TO 8MMHG. ALTHOUGH THE GRADIENT INCREASED TO 8MMHG, THE PHYSICIAN WAS SATISFIED WITH THE RESULTS OF THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: Mitral Valve Stenosis

  MAUDE report 23480463 ↗
• MalfunctionNov 4, 2025Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED ON (B)(6) 2025 THAT THE PATIENT PRESENTED WITH GRADE 4 FUNCTIONAL MITRAL REGURGITATION (MR), RESTRICTED POSTERIOR LEAFLET AND THICK POSTERIOR LEAFLET TIP FOR MITRACLIP PROCEDURE. DURING THE PROCEDURE, 2 MITRACLIPS WERE IMPLANTED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED. ON ESTIMATED DATE, IT WAS DETERMINED THAT A SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) OCCURRED FOR 2 MITRACLIPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23467266 ↗
• InjuryNov 4, 2025Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED ON (B)(6) 2025 THAT THE PATIENT PRESENTED WITH GRADE 4 FUNCTIONAL MITRAL REGURGITATION (MR), RESTRICTED POSTERIOR LEAFLET AND THICK POSTERIOR LEAFLET TIP FOR MITRACLIP PROCEDURE. DURING THE PROCEDURE, 2 MITRACLIPS WERE IMPLANTED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED. ON ESTIMATED DATE, IT WAS DETERMINED THAT A SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) OCCURRED FOR 2 MITRACLIPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23467262 ↗
• MalfunctionOct 24, 2025Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THAT A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT MIXED MITRAL REGURGITATION (MR) WITH A GRADE OF 4+, ON A PATIENT WITH RESTRICTED ANTERIOR LEAFLET, RESTRICTED POSTERIOR LEAFLET, FLAIL, MITRAL ANNULAR CALCIFICATION (MAC), TETHERING OF THE ANTERIOR LEAFLET, AND PROMINENT CHORDAE. A MITRACLIP XTW WAS INSERTED AND DEPLOYED ON THE MITRAL VALVE. A SECOND CLIP, A MITRACLIP XT WAS THEN INSERTED AND DEPLOYED ON THE MITRAL VALVE. HOWEVER, DIFFICULTIES VISUALIZING THE CLIP OCCURRED, AND AFTER DEPLOYMENT OF THE SECOND CLIP, THE CLIP DETACHED FROM THE ANTERIOR LEAFLET AND REMAINED ATTACHED TO THE POSTERIOR LEAFLET (SINGLE LEAFLET DEVICE ATTACHMENT/SLDA). IT WAS NOTED THAT THE SLDA. NO ADDITIONAL CLIPS WERE IMPLANTED, AND THE CLIP REMAINED STABLE. THE MR WAS REDUCED 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 23380803 ↗
• InjuryOct 15, 2025Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED ON (B)(6) 2025 THAT THE PATIENT PRESENTED WITH GRADE 4+ DEGENERATIVE MITRAL REGURGITATION (MR) FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, MITRACLIP WAS ADVANCED INTO LEFT ATRIUM. A CLOT WAS OBSERVED AT THE END OF THE CLIP. THE CLIP WAS RETRACTED INTO THE STEERABLE GUIDE CATHETER (SGC) FOR REMOVAL OF CLOT. UPON REMOVAL, THE CLIP DAMAGED THE HEMOSTATIC VALVE OF THE SGC. THE CLIP AND SGC WERE REPLACED WITH ANOTHER DEVICES TO COMPLETE THE PROCEDURE. THE MR WAS REDUCED TO GRADE 1+ POST PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23295392 ↗
• MalfunctionOct 3, 2025Difficult or Delayed Positioning; Difficult or Delayed Activation; Difficult to Open or Close; Difficult or Delayed Positioning; Difficult or Delayed Activation; Difficult to Open or Close

  IT WAS REPORTED ON (B)(6) 2025 THAT THE PATIENT PRESENTED WITH GRADE 4 DEGENERATIVE MITRAL REGURGITATION (MR) FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, ONE MITRACLIP WAS IMPLANTED SUCCESSFULLY. DURING DEPLOYMENT OF SECOND MITRACLIP, GRIPPER GOT CAUGHT IN THE CHORDAE. TROUBLESHOOTING WAS PERFORMED AND ANOTHER GRIPPER GOT STUCK IN POSTERIOR CHORDAE. THE GRIPPERS WERE FREE AFTER PERFORMING STANDARD TROUBLESHOOTING. THE ACTUATOR KNOB WAS ABLE TO TURN BUT THE CLIP WAS UNABLE TO RELEASE. THE GRIPPERS WERE ABLE TO LOWER AND THE LEAFLETS WERE CAPTURED IN THE CLIP AND WAS DEPLOYED SUCCESSFULLY. 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 23213391 ↗