MitraClip™ CDS0706-XTWRecalls & reported problems

Summary

The FDA's MAUDE database contains 1,341 adverse event reports that list this exact device (DI 05415067037381), received between Nov 9, 2022 and Jul 27, 2026 — classified as 31 deaths, 776 injuries, 534 malfunctions.

The most frequently reported specific device problem is “Incomplete Coaptation” (380 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 1,341 reports, in the reporter's own words as published by the FDA.

• DeathJul 27, 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 and a restricted posterior leaflet. One clip was successfully implanted, reducing MR to a grade of 1+. On (b)(6) 2026, the patient passed away. The cause of death is unknown. The patient had pulmonary disease. There were no complications with the MitraClip, the clip remained stable on both leaflets.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50024353 ↗
• InjuryJul 27, 2026Incomplete Coaptation

  It was reported that on (b)(6) 2024, a patient presented with grade 4 degenerative mitral regurgitation (MR) for a Mitraclip procedure. The final MR was grade 1. There were no adverse patient effects or clinically significant delays reported. On (b)(6) 2026, patient returned with declined ejection fraction, increase in fluid retention, shortness of breath. Transesophageal echocardiogram (TEE) was performed, and it was determined that there was a single leaflet device attachment (SLDA) and the clip was no longer attached to the posterior leaflet. MR was moderate to severe after SLDA

  Patient problems: Dyspnea; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 50013491 ↗
• MalfunctionJun 3, 2026

  ON [REDACTED], DURING RIGHT AND LEFT HEART CATHETERIZATION PERFORMED AS PART OF THE PRE-SURGICAL EVALUATION, FLUOROSCOPY DEMONSTRATED MIGRATION OF ONE MITRACLIP INTO THE LEFT ATRIUM IN A FIXED POSITION. IMMEDIATELY FOLLOWING THE PROCEDURE, THE PATIENT DEVELOPED ALTERED MENTAL STATUS AND RIGHT-SIDED WEAKNESS, PROMPTING ACTIVATION OF A STROKE ALERT. CT IMAGING OF THE HEAD DEMONSTRATED A MIGRATED APPROXIMATELY 1 CM MITRACLIP FRAGMENT WITHIN THE BASILAR ARTERY. THE PATIENT'S NEUROLOGICAL DEFICITS SUBSEQUENTLY RESOLVED WITHOUT INTERVENTION, AND THE PATIENT RETURNED TO NEUROLOGIC BASELINE. ABBOTT, THE MITRACLIP MANUFACTURER, WAS NOTIFIED OF THE EVENT.

  Patient problems: Altered State of Consciousness; Muscle Weakness/Atrophy

  MAUDE report 25373846 ↗
• InjuryJun 1, 2026Material Deformation; Physical Resistance/Sticking

  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, RESISTANCE WAS NOTED DURING REMOVAL OF THE LOCK LINE. AT THAT TIME, ONLY ONE END OF THE LOCK LINE WAS ACCESSIBLE, AND TRACTION WAS APPLIED UNTIL PARTIAL WITHDRAWAL OF THE LINE WAS ACHIEVED. A KNOT WAS OBSERVED WHILE REMOVAL ATTEMPTS WERE MADE. THE LOCK LINE SUBSEQUENTLY BECAME RESTRICTED AGAIN AND COULD NOT BE FURTHER REMOVED. A DECISION WAS MADE TO APPLY TENSION TO THE LOCK LINE WHILE ATTEMPTING TO OPEN THE CLIP. THIS MANEUVER RESULTED IN UNLOCKING OF THE CLIP. THE CLIP WAS SUCCESSFULLY OPENED AND INVERTED FOR RETRACTION INTO THE LEFT ATRIUM. THE CLIP WAS THEN REMOVED FROM THE ANATOMY, AND A REPLACEMENT CLIP WAS UTILIZED 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 25350976 ↗
• MalfunctionMay 11, 2026Incomplete Coaptation

  IT WAS REPORTED ON (B)(6) 2026 THAT THE PATIENT PRESENTED WITH GRADE 4+ FUNCTIONAL MITRAL REGURGITATION (MR) AND FLAIL AND CALCIFIED POSTERIOR LEAFLET FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, A MITRACLIP WAS SUCCESSFULLY IMPLANTED. POST DEPLOYMENT, THE CLIP HAD SINGLE LEAFLET DEVICE ATTACHMENT(SLDA) FROM THE POSTERIOR LEAFLET. ANOTHER MITRACLIP WAS IMPLANTED. THE MR WAS REDUCED TO GRADE 2+ POST PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY OR ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25142447 ↗
• InjuryApr 22, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON AN (B)(6) 2025 THAT A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT GRADE 4 FUNCTIONAL MITRAL REGURGITATION (MR). TWO MITRACLIPS WERE IMPLANTED. THE MR WAS REDUCED TO GRADE 2 POST PROCEDURE. ON AN UNKNOWN DAY, RECURRENT MR OF GRADE 3 WAS REPORTED. THE PATIENT WAS SYMPTOMATIC WITH DYSPNEA. ON (B)(6) 2026, AN ECHOCARDIOGRAM WAS PERFORMED AND REVEALED RECURRENT MR WITH A GRADE OF 3. A SECOND MITRACLIP PROCEDURE WAS THEN PERFORMED, AND ONE CLIP WAS IMPLANTED, REDUCING MR TO A GRADE OF 2.

  Patient problems: Dyspnea; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 24955741 ↗
• MalfunctionApr 20, 2026Difficult to Open or Close

  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, ONE GRIPPER WAS UNABLE TO LOWER. 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 REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24925326 ↗
• MalfunctionApr 10, 2026Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT PRESENTED WITH GRADE 4+ FUNCTIONAL MITRAL REGURGITATION (MR) RESTRICTION FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, FIRST MITRACLIP XTW WAS IMPLANTED ON THE ANTERIOR AND POSTERIOR LEAFLET 2 (A2/P2) AND IT WAS DETERMINED THAT THERE WAS A SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) AND THE CLIP WAS NO LONGER ATTACHED TO THE POSTERIOR LEAFLET. SECOND MITRACLIP XTW WAS IMPLANTED ON THE LATERAL SIDE OF ANTERIOR AND POSTERIOR LEAFLET 2 (A2/P2) AND THIRD MITRACLIP NT WAS IMPLANTED ON THE MEDIAL SIDE OF ANTERIOR AND POSTERIOR LEAFLET 2 (A2/P2). 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 24844407 ↗
• MalfunctionMar 30, 2026Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT PRESENTED WITH GRADE 4+ FUNCTIONAL MITRAL REGURGITATION (MR) AND ENLARGED ATRIUM FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, MITRACLIP WAS IMPLANTED. THE FINAL MR WAS GRADE 1-2. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED. ON (B)(6) 2026, IT WAS DETERMINED THAT A SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) HAS OCCURRED AND THE CLIP WAS NO LONGER ATTACHED TO THE POSTERIOR LEAFLET. PER THE PHYSICIAN, SLDA WAS DUE TO THE PRE-EXISTING PATIENT ANATOMY OF LARGE ATRIUM THAT CAUSED THE LEAFLETS TO BE FLAT OR HORIZONTAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24716490 ↗
• InjuryMar 20, 2026Incomplete Coaptation; Device Damaged by Another Device

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT PRESENTED WITH DEGENERATIVE MITRAL REGURGITATION (MR), MYXOMATOUS POSTERIOR LEAFLET 2, WIDE PROLAPSE OF MORE THAN 15MM AND FLAIL GAP OF 10MM FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, FIRST MITRACLIP WAS IMPLANTED. DURING IMPLANTATION OF SECOND MITRACLIP, FIRST GRASP WAS DIFFICULT AND THERE WAS INTERACTION WITH CHORDS. SECOND MITRACLIP WAS PLACED ON THE CENTRAL SIDE OF ANTERIOR AND POSTERIOR LEAFLET 2 (A2P2), AS THERE WAS NO CHANGE IN THE MR, THE CLIP WAS MOVED TO THE MEDIAL SIDE OF THE FIRST CLIP AND THERE WAS NO SIGNIFICANT MR REDUCTION. IT WAS DECIDED TO MOVE CLOSER TO THE FIRST CLIP, GRASPING WAS OBTAINED WITHOUT SIGNIFICANT MR REDUCTION AND INCREASE IN THE GRADIENT TO ABOVE 6 MMHG. IT WAS DECIDED TO INVERT THE CLIP AND COME INTO THE LEFT ATRIUM. CLIP WAS CLOSED AND WAS MOVED LATERAL TO THE FIRST CLIP. FIRST CLIP APPEARED TO BE STABLE FROM THE INITIAL RELEASE. PARALAX WAS REMOVED FROM THE SECOND CLIP TO MATCH THE FIRST CLIP. SECOND CLIP WAS OPENED AND IT WAS DETERMINED THAT THE CLIP INTERACTED WITH THE POSTERIOR MITRAL LEAFLET AND THE FLAIL SEGMENT. CLIP WAS INVERTED AND RETRACTED. CLIP WAS INITIALLY THOUGHT TO BE FREED FROM

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 24652203 ↗
• MalfunctionMar 20, 2026Positioning Failure; Device Damaged by Another Device

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT PRESENTED WITH DEGENERATIVE MITRAL REGURGITATION (MR), MYXOMATOUS POSTERIOR LEAFLET 2, WIDE PROLAPSE OF MORE THAN 15MM AND FLAIL GAP OF 10MM FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, FIRST MITRACLIP WAS IMPLANTED. DURING IMPLANTATION OF SECOND MITRACLIP, FIRST GRASP WAS DIFFICULT AND THERE WAS INTERACTION WITH CHORDS. SECOND MITRACLIP WAS PLACED ON THE CENTRAL SIDE OF ANTERIOR AND POSTERIOR LEAFLET 2 (A2P2), AS THERE WAS NO CHANGE IN THE MR, THE CLIP WAS MOVED TO THE MEDIAL SIDE OF THE FIRST CLIP AND THERE WAS NO SIGNIFICANT MR REDUCTION. IT WAS DECIDED TO MOVE CLOSER TO THE FIRST CLIP, GRASPING WAS OBTAINED WITHOUT SIGNIFICANT MR REDUCTION AND INCREASE IN THE GRADIENT TO ABOVE 6 MMHG. IT WAS DECIDED TO INVERT THE CLIP AND COME INTO THE LEFT ATRIUM. CLIP WAS CLOSED AND WAS MOVED LATERAL TO THE FIRST CLIP. FIRST CLIP APPEARED TO BE STABLE FROM THE INITIAL RELEASE. PARALAX WAS REMOVED FROM THE SECOND CLIP TO MATCH THE FIRST CLIP. SECOND CLIP WAS OPENED AND IT WAS DETERMINED THAT THE CLIP INTERACTED WITH THE POSTERIOR MITRAL LEAFLET AND THE FLAIL SEGMENT. CLIP WAS INVERTED AND RETRACTED. CLIP WAS INITIALLY THOUGHT TO BE FREED FROM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24652155 ↗
• InjuryMar 12, 2026Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2025, A PATIENT PRESENTED WITH GRADE 4 FUNCTIONAL MITRAL REGURGITATION (MR) AND THIN FRIABLE LEAFLETS FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, MITRACLIP XTW WAS IMPLANTED SUCCESSFULLY. 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 A SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) HAS OCCURRED AND THE CLIP WAS LONGER ATTACHED TO THE POSTERIOR LEAFLET. MR WAS GRADE 4 AFTER SLDA. PATIENT RETURNED WITH DYSPNEA ON EXERTION (DOE) AND SHORTNESS OF BREATH (SOB) ON (B)(6) 2026, ADDITIONAL MITRACLIP XT WAS PLACED ON LATERAL SIDE OF THE FIRST CLIP FOR STABILIZATION. THE FINAL MR WAS GRADE 1.

  Patient problems: Dyspnea; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 24586451 ↗
• InjuryMar 12, 2026Incomplete Coaptation

  IT WAS REPORTED THAT ON 18 FEBRUARY 2026, A PATIENT PRESENTED WITH GRADE 4 MIXED MITRAL REGURGITATION (MR), TETHERED POSTERIOR LEAFLET AND A PROLAPSED FLAIL ANTERIOR LEAFLET FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, FIRST MITRACLIP WAS IMPLANTED AND WHILE SECOND CLIP IN THE LEFT ATRIUM, IT WAS DETERMINED THAT A SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) HAS OCCURRED FOR THE FIRST CLIP AND THE CLIP WAS NO LONGER ATTACHED TO THE POSTERIOR LEAFLET. SECOND CLIP WAS IMPLANTED ON LATERAL SIDE OF THE FIRST CLIP. IT WAS REPORTED THAT THERE WAS NO INTERACTION BETWEEN THE FIRST CLIP AND SECOND CLIP. IT WAS BELIEVED THAT LEAFLET INSERTION WAS NOT ADEQUATE. THIRD CLIP WAS IMPLANTED TO STABILIZE THE FIRST AND SECOND CLIP. IMAGING WAS DIFFICULT. PER THE PHYSICIAN, SLDA WAS DUE TO PRE-EXISTING PATIENT ANATOMY OF BOTH FRIABLE TISSUE COUPLED WITH EXCESSIVE MOBILITY OF THE ANTERIOR PROLAPSED, FLAILED LEAFLET. THE FINAL MR WAS GRADE 2. WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24586321 ↗
• InjuryMar 11, 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. THE FINAL MR WAS GRADE 1+. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED. ON AN UNKNOW DATE, PHYSICIAN OBSERVED THAT THERE WAS RECURRENT MR WITH GRADE 4. PHYSICIAN BELIEVED THAT THERE WAS POSSIBLE SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) HAS OCCURRED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 24570606 ↗
• InjuryMar 10, 2026Incomplete Coaptation

  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, TWO MITRACLIP XTW'S WERE SUCCESSFULLY IMPLANTED. THE FINAL MR WAS GRADE 2+. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED. ON AN ESTIMATED DATE, (B)(6) 2026, THE PATIENT RETURNED SYMPTOMATIC WITH HEART FAILURE SYMPTOMS FOR A TRANSTHORACIC ECHOCARDIOGRAM (TTE), IT WAS IDENTIFIED THAT THE FIRST MITRACLIP XTW HAD A SINGLE LEAFLET DETACHMENT (SLDA). THE MR RETURNED TO 4+.

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

  MAUDE report 24560178 ↗
• InjuryFeb 27, 2026Unintended Movement

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT PRESENTED WITH GRADE 4+ FUNCTIONAL MITRAL REGURGITATION (MR), RESTRICTED POSTERIOR LEAFLET AND HEART FAILURE FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, FIRST MITRACLIP WAS IMPLANTED AND IT WAS OBSERVED THAT THE CLIP APPEARED TO RELAX AFTER THE DEPLOYMENT. ADDITIONAL SECOND CLIP WAS IMPLANTED TO STABILIZE THE FIRST CLIP AND FURTHER REDUCE THE MR. 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 THE NEXT DAY, PHYSICIAN NOTED THAT THE CLIP APPEARED MORE RELAXED. IT WAS NOTED THAT WAS NO CHANGE IN THE MR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24472999 ↗
• MalfunctionFeb 27, 2026Positioning Failure; Difficult to Open or Close

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT PRESENTED WITH GRADE 4+ FUNCTIONAL MITRAL REGURGITATION (MR), WIDE CENTRAL JET AND SEVERE-TORRENTIAL MR FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, FIRST MITRACLIP WAS IMPLANTED ON THE MEDIAL SIDE OF ANTERIOR AND POSTERIOR LEAFLET (A2P2). SECOND MITRACLIP WAS ADVANCED INTO THE LEFT VENTRICLE ON THE LATERAL SIDE OF THE FIRST CLIP. AFTER SUCCESSFUL GRASP, IT WAS DETERMINED THE CLIP NEEDED TO BE MOVED MORE MEDIAL. GRIPPERS WERE RAISED AND CLIP WAS RELEASED. DURING THE SECOND GRASP, ANTERIOR GRIPPER WOULD NOT LOWER OR RAISE. TROUBLESHOOTING WAS PERFORMED BUT WAS UNSUCCESSFUL. IT WAS DECIDED TO REMOVE THE CLIP FROM THE PATIENT BUT WHILE REMOVING IT WAS OBSERVED THAT THE ANTERIOR LEAFLET WAS CAUGHT ON THE ANTERIOR GRIPPER. IMPLANTER ROTATED THE SGC AND ADVANCED INTO THE VENTRICLE AND WAS ABLE TO REMOVE THE STUCK LEAFLET. CDS WAS REMOVED SUCCESSFULLY. ANOTHER MITRACLIP XT WAS IMPLANTED ON THE LATERAL SIDE OF THE FIRST CLIP. IMAGING WAS DIFFICULT. ALL STEPS WERE PERFORMED AS PER IFU. THE FINAL MR WAS GRADE 3. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24470408 ↗
• InjuryFeb 26, 2026Incomplete Coaptation

  ON (B)(6) 2025, THE PATIENT PRESENTED WITH GRADE 4 FUNCTIONAL MITRAL REGURGITATION (MR) AND ENLARGED ATRIUM FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, 2 MITRACLIPS WAS SUCCESSFULLY IMPLANTED. THE MR WAS REDUCED TO GRADE 1-2 POST PROCEDURE. APPROXIMATELY ON (B)(6) 2025, THE SECOND CLIP HAD SINGLE LEAFLET DEVICE ATTACHMENT(SLDA) FROM THE ANTERIOR LEAFLET. RECURRENT MR OF GRADE 4 WAS REPORTED. ON (B)(6) 2026, A RE-INTERVENTION PROCEDURE WAS PERFORMED. 2 MITRACLIPS WERE IMPLANTED TO STABILIZE THE SLDA CLIP. THE MR WAS REDUCED TO GRADE 2 POST PROCEDURE.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 24462344 ↗
• InjuryFeb 24, 2026Difficult or Delayed Positioning; Unintended Movement

  IT WAS REPORTED THAT A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT GRADE 4 MITRAL REGURGITATION (MR) IN AN 81-YEAR-OLD PATIENT WITH THIN, WISPY LEAFLETS, MITRAL ANNULAR CALCIFICATION (MAC), AND A CHALLENGING TRANSSEPTAL PUNCTURE THAT RESULTED IN LIMITED STEERING CAPABILITY. A MITRACLIP XTW WAS INSERTED. HOWEVER, IT WAS NOTED THAT THERE WAS LIMITED ROOM TO STEER THE DEVICE DUE TO THE TRANSSEPTAL PUNCTURE. DESPITE THIS, THE FIRST CLIP WAS SUCCESSFULLY DEPLOYED ON THE MITRAL VALVE. FOLLOWING DEPLOYMENT, THE PHYSICIAN PROVIDED A VISUAL OBSERVATION, THOUGH IT WAS NOT CLEAR WHETHER THE OBSERVATION WAS RELATED TO NORMAL POST-DEPLOYMENT SETTLING OR ANY OTHER DEVICE-RELATED FINDING. IT WAS NOTED THAT THE CLIP ANGLE BEFORE OPENING WAS 20 DEGREES. THE CLIP ANGLE AFTER OPENING WAS UNDETERMINED BUT IT WAS NOTED THAT IT WAS OVER 20 DEGREES. HOWEVER, IT WAS REPORTED THAT THE CLIP REMAINED STABLE ON THE LEAFLETS, AND THE OUTCOME WAS DEEMED POSITIVE, WITH THE PATIENT¿S MR IMPROVING FROM SEVERE TO MODERATE, WITH NO ADVERSE PATIENT CONSEQUENCES. AFTER THE IMPLANT OF THE INITIAL CLIP, THERE WAS REDUCTION IN MITRAL REGURGITATION. THE PHYSICIAN THOUGHT THE CLIP HAD OPENED BUT WAS NOT SURE IF IT WAS CLIP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24430655 ↗
• MalfunctionFeb 20, 2026Incomplete Coaptation; Device Damaged by Another Device

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24402804 ↗
• MalfunctionFeb 19, 2026Unintended Movement

  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 PERFORMING THE ESTABLISH FINAL ARM ANGLE (EFAA), THE CLIP OPENED. THE CLIP WAS THEN RELOCKED AND CLOSED FOR THE SECOND ATTEMPT, IT FAILED AGAIN. THE CLIP WAS SUCCESSFULLY REMOVED FROM THE PATIENT AND REPLACED WITH ANOTHER CLIP. ALL STEPS WERE PERFORMED AS PER IFU. 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 24390348 ↗
• DeathFeb 16, 2026Expulsion

  IT WAS REPORTED ON (B)(6) 2026 THAT THE PATIENT PRESENTED WITH GRADE 4 DEGENERATIVE MITRAL REGURGITATION (MR), FRIABLE LEAFLETS, THICK AND FLAIL POSTERIOR LEAFLET AND CANCER FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, A MITRACLIP WAS SUCCESSFULLY IMPLANTED. THE MR WAS REDUCED TO GRADE 1+ POST PROCEDURE. POST PROCEDURE, THE PATIENT BECAME SYMPTOMATIC, PRESENTING WITH PAIN AND HEMORRHAGE. PER THE PHYSICIAN, THESE SYMPTOMS WERE CONSIDERED UNRELATED TO THE MITRACLIP PROCEDURE. SUBSEQUENT X-RAY IMAGING DEMONSTRATED COMPLETE DETACHMENT OF THE CLIP FROM BOTH MITRAL LEAFLETS. THE DETACHED CLIP WAS VISUALIZED AT THE BIFURCATION OF THE DISTAL ILIAC AORTA. THE PATIENT SUBSEQUENTLY DIED DUE TO HEART FAILURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY REPORTED.

  Patient problems: Foreign Body In Patient; Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 24344470 ↗
• MalfunctionFeb 13, 2026Unintended Movement

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24332973 ↗
• InjuryFeb 6, 2026Unintended Movement; Migration

  IT WAS REPORTED ON (B)(6) 2026 THAT THE PATIENT PRESENTED WITH GRADE 4 DEGENERATIVE MITRAL REGURGITATION (MR), ENLARGED ATRIUM AND PROLAPSED LEAFLET FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, THE CLIP OPENED TO 30-40 DEGREE POST DEPLOYMENT. PARTIAL CLIP MOMENT WAS OBSERVED POST OPENING. ANOTHER MITRACLIP WAS DEPLOYED TO STABILIZE THE OPENED CLIP. PER THE PHYSICIAN, STEERABLE GUIDE CATHETER (SGC) WAS UNABLE TO HOLD COLUMN AFTER REMOVING THE FIRST CLIP. ASPIRATION RESOLVED THE ISSUE. 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 24278823 ↗
• InjuryFeb 4, 2026Difficult or Delayed Positioning

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT PRESENTED WITH GRADE 4+ FUNCTIONAL MITRAL REGURGITATION (MR), ROTATED HEART, MITRAL ANNULAR CALCIFICATION (MAC) AND THIN LEAFLETS FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, FIRST MITRACLIP WAS IMPLANTED ON MEDIAL SIDE OF ANTERIOR AND POSTERIOR LEAFLET 2 (A2/P2) WITH MINOR REDUCTION IN THE MR. SEVERAL ATTEMPTS WERE MADE TO PLACE THE SECOND CLIP CLOSER TO THE FIRST CLIP, HOWEVER DUE TO THE WEAK TISSUE, POSTERIOR LEAFLET WAS KEPT COMING OFF, THERE WAS DIFFICULTY GRASPING AND CAPTURING THE LEAFLETS. IT WAS DECIDED TO IMPLANT THE SECOND CLIP ON THE LATERAL SIDE WITH NO REDUCTION IN THE MR. IT WAS OBSERVED THAT THERE WAS A LEAFLET DAMAGE IN THE AREA OF INITIAL GRASP. IMAGING WAS DIFFICULT. INTRA-AORTIC BALLOON PUMP (IABP) WAS INSERTED TO THE PATIENT. PER THE PHYSICIAN, LEAFLET DAMAGE WAS DUE TO THE PATIENT PATHOLOGY, FRAIL BODY HABITUS AND FRIABLE LEAFLETS. THE FINAL MR WAS GRADE 4+. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED.

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

  MAUDE report 24260845 ↗