MitraClip™ CDS0801-NTRecalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 05415067050717), received between Jun 12, 2025 and Aug 28, 2026 — classified as 1 death, 26 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Close” (12 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 49 reports, in the reporter's own words as published by the FDA.

• DeathAug 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that on (b)(6) 2026, a patient presented with grade 4 functional mitral regurgitation (MR), thin friable tissue for a Mitraclip procedure. During the procedure, two MitraClip XT were implanted. During implantation of a third MitraClip XT, multiple grasps were made on the friable tissue. A leaflet tear was then observed. The third clip was removed from the patient and replaced with a MitraClip NT. The third clip was implanted. The final MR remained at grade 4.On (b)(6) 2026 the patient presented with heart failure with a v wave of 70mmHg. A balloon pump was inserted but did not resolve symptoms. The patient passed away. The clips remained stable at the time of death. The physician believed the tissue injury was due to the MitraClip and overall tissue integrity.

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

  MAUDE report 50500551 ↗
• InjuryAug 6, 2026Premature Activation

  It was reported that on (b)(6) 2026, a patient presented with grade 2-3 mixed mitral regurgitation (MR) for a MitraClip procedure. During the procedure, a MitraClip NT was successfully placed on the leaflets. While opening the clip to regrasp the posterior leaflet, the mandrel of the MitraClip NT detached. The clip was deployed only attached to one leaflet, the clip was not attached to the posterior leaflet. A second MitraClip NT was selected and implanted successfully to stabilize the first clip. The procedure was discontinued, the final MR was grade 3 and the mean pressure gradient (MPG) increased to 7mmHg. There were no clinically significant delays reported.

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

  MAUDE report 50162016 ↗
• MalfunctionJul 31, 2026Difficult to Open or Close; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50099006 ↗
• InjuryJul 30, 2026Difficult to Open or Close

  It was reported on(b)(6) 2026 that the patient presented with grade 3 functional mitral regurgitation (MR) and calcified valve for a MitraClip procedure. Imaging was sub-optimal due to patient's complex anatomy. During the procedure, one gripper of the MitraClip NT failed to fully lower and raise during independent gripper actuation. After troubleshooting, the gripper functioned normally; however, the physician elected not to use the device. Following troubleshooting, leaflet damage was noted. As a result, the device was removed from the anatomy.A replacement clip was subsequently utilized to complete the procedure. The MR was reduced to grade 1-2 post procedure. There was no clinically significant delay reported.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50083414 ↗
• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that a MitraClip procedure was performed to treat mixed mitral regurgitation (MR) with a grade of 4, a mean pressure gradient of 3-4 mmHg on a patient with a small mitral valve area (MVA), and chordal thickening. A MitraClip NT was inserted and grasping was performed. However, the mitral valve gradient (MVG) increased to 5-8 mmHg. A decision was made to implant the clip, and the clip was implanted. Post deployment, the gradient increased to 6mmHg. Despite the increase in gradient, the physician was satisfied with the result. There were no device issues. No additional clips were implanted, and the MR was reduced to a grade of 1.However, post procedure, the gradient increased to 12-14 mmHg. The patient did not experience any adverse effects due to the increase in pressure gradient. The patient was reported to be stable, okay, and discharged.

  Patient problems: Mitral Valve Stenosis

  MAUDE report 50063425 ↗
• InjuryJul 27, 2026Incomplete Coaptation

  It was reported that on (b)(6) 2026, a patient presented with grade 4 functional mitral regurgitation (MR), thick leaflets, restricted posterior leaflet for a Mitraclip procedure. During the procedure, first and second mitraclip was implanted. After 5 minutes of deployment, it was determined that there was a single leaflet device attachment (SLDA) and the clip was no longer attached to the anterior leaflet. Third clip was implanted to stabilize the SLDA. Imaging was difficult. The final MR was grade 2-3. There were no adverse patient effects or clinically significant delays reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50020428 ↗
• InjuryJul 1, 2026Incomplete Coaptation

  IT WAS REPORTED ON (B)(6) 2026 THAT THE PATIENT PRESENTED WITH GRADE 4+ FUNCTIONAL TRICUSPID REGURGITATION (TR), THIN LEAFLET AND CALCIFIED ANNULUS FOR A TRICLIP PROCEDURE. DURING THE PROCEDURE, A TRICLIP WAS SUCCESSFULLY IMPLANTED. DURING DEPLOYMENT OF SECOND TRICLIP, THE CLIP HAD SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) FROM THE POSTERIOR LEAFLET. ADDITIONAL CLIP WAS IMPLANTED TO STABILIZE THE SLDA CLIP. THE TR WAS REDUCED TO GRADE 2 POST PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25680704 ↗
• InjuryJun 24, 2026Difficult to Remove; Migration

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT PRESENTED WITH GRADE 4 FUNCTIONAL MITRAL REGURGITATION (MR) AND A RESTRICTED POSTERIOR LEAFLET FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, A MITRACLIP WAS SUCCESSFULLY ADVANCED WITHIN THE PATIENT AND PLACED ON THE LEAFLETS. DURING DEPLOYMENT, THE LOCKLINE WAS UNABLE TO BE FULLY REMOVED. TROUBLESHOOTING WAS PERFORMED AND THE DEPLOYMENT SEPS WERE CONTINUED, SUCCESSFULLY DEPLOYING THE CLIP. WHILE RETRIEVING THE LOCKLINE IT WAS IDENTIFIED THAT THERE WAS A KNOT IN THE MIDDLE. A SECONDARY MITRACLIP WAS IMPLANTED TO STABILIZE THE FIRST CLIP AND FURHTER REDUCE THE MR. THE PROCEDURE WAS DISCONTINUED, 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 25612531 ↗
• MalfunctionJun 12, 2026Unintended Movement

  IT WAS REPORTED ON (B)(6) 2026 THAT THE PATIENT PRESENTED WITH GRADE 4 DEGENERATIVE MITRAL REGURGITATION (MR) AND PROLAPSED ANTERIOR LEAFLET FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, UPON TURNING THE M KNOB, THE SLEEVE SHOWCASED UNINTENDED MOVEMENT. THE CLIP WAS REMOVED FROM THE ANATOMY. THE SAME ISSUE WAS OBSERVED IN THREE MORE CLIPS. HOWEVER, THE THREE CLIPS WERE DEPLOYED SUCCESSFULLY. THE MR WAS REDUCED TO GRADE 3-4 POST PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY OR ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25485369 ↗
• InjuryJun 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2026 THAT THE PATIENT PRESENTED WITH GRADE 4 DEGENERATIVE MITRAL REGURGITATION (MR) AND FLAIL LEAFLET FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, PERFORATION OF LEAFLET WAS OBSERVED. THE PROCEDURE WAS TERMINATED WITH REMOVAL OF CLIP FROM THE ANATOMY. THE MR REMAINED UNCHANGED POST PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY REPORTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 25472788 ↗
• InjuryJun 10, 2026Entrapment of Device; Difficult to Open or Close

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT PRESENTED WITH GRADE 3 FUNCTIONAL MITRAL REGURGITATION (MR) FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, A MITRACLIP BECAME ENTANGLED ON THE SUBVALVULAR APPARATUS. TROUBLESHOOTING WAS PERFORMED UNSUCCESSFULLY AND IT WAS DECIDED THAT THE CLIP WOULD BE IMPLANTED. WHEN THE GRIPPERS WERE DROPPED IT WAS VISUALIZED THAT ON OF THE GRIPPERS WOULD NOT DESCEND. THE CLIP WAS CLOSED AND SUCCESSFULLY DEPLOYED. AN ADDITIONAL MITRACLIP WAS IMPLANTED TO FURTHER REDUCE THE MR. THE PROCEDURE WAS DISCONTINUED, THE FINAL MR WAS REDUCED TO GRADE 1. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25457902 ↗
• InjuryJun 3, 2026Adverse Event Without Identified Device or Use Problem

  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, CLIP DELIVERY SYSTEM (CDS) DEVELOPED THROMBUS. IT WAS DUE TO THE ADMINISTRATION OF AMOUNT OF ANTICOAGULANT. DEVICE WAS REMOVED FROM THE PATIENT AND WAS REPLACED WITH NEW DEVICE. THE FINAL MR WAS GRADE 1-2. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 25386021 ↗
• MalfunctionJun 1, 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, FIRST AND SECOND MITRACLIP NTW WERE IMPLANTED ON THE MEDIAL AND CENTRAL SIDE OF ANTERIOR AND POSTERIOR LEAFLET (A2P2). MITRACLIP NT WAS INSERTED INTO THE PATIENT AND WAS PLACED ON LATERAL SIDE OF ANTERIOR AND POSTERIOR LEAFLET 3 (A3P3). MITRACLIP NT WAS ENTANGLED WITH THE MEDIAL MITRACLIP NTW. MITRACLIP NT WAS FREED AND WAS INVERTED AND BROUGHT TO THE LEFT ATRIUM. ORIENTATION WAS CHECKED AND WENT SUB VALVULAR. A3P3 LEAFLETS WERE GRASPED AND LEAFLET INSERTED WAS CHECKED AND THE MITRACLIP NT WAS IMPLANTED. UPON, RELEASE OF THE CLIP, CLIP OPENED. 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 25350848 ↗
• MalfunctionMay 19, 2026Difficult or Delayed Activation

  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, LEAFLETS WERE GRASPED AND IT WAS ATTEMPTED TO RELEASE THE DEVICE, BUT IT REMAINED ATTACHED AND DID NOT RELEASE AS EXPECTED. TROUBLESHOOTING WAS PERFORMED, GRIPPER CAPS WERE REMOVED FROM THE LOCK AND GRIPPER LINES WERE REMOVED AND THE CLIP WAS SUCCESSFULLY RELEASED. IT WAS NOTED THAT THE CLIP WAS ATTACHED TO BOTH THE LEAFLETS. 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 25219046 ↗
• MalfunctionMay 14, 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, THE GRIPPES WERE UNABLE TO LOWER WHILE PERFORMING 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 REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25177155 ↗
• InjuryApr 24, 2026Incomplete Coaptation

  IT WAS REPORTED ON (B)(6) 2026 THAT THE PATIENT PRESENTED WITH GRADE 3 DEGENERATIVE MITRAL REGURGITATION (MR), CORONARY ARTERY DISEASE (CAD), HYPERTENSION (HTN), HYPERLIPIDEMIA (HLD), ASCENDING AORTIC DILATION, ATRIAL FIBRILLATION (AFIB), PERIPHERAL ARTERY DISEASE (PAD), RIGHT CAROTID ENDARTERECTOMY AND THIN 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 ANTERIOR LEAFLET. ANOTHER MITRACLIP WAS IMPLANTED FOR STABILIZATION OF SLDA CLIP. THE MR WAS REDUCED TO GRADE 1-2 POST PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24988156 ↗
• InjuryApr 7, 2026Positioning Failure

  IT WAS REPORTED ON (B)(6) 2026 THAT THE PATIENT PRESENTED WITH GRADE 4 FUNCTIONAL MITRAL REGURGITATION (MR) AND A RESTRICTED POSTERIOR LEAFLET FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, A MITRACLIP WAS SUCCESSFULLY IMPLANTED. DURING THE DEPLOYMENT SEQUENCE OF THE SECOND MITRACLIP NT, DIFFICULTY WAS ENCOUNTERED WHILE CAPTURING AND GRASPING THE LEAFLETS. MULTIPLE GRASPING ATTEMPTS WERE MADE, WHICH CONTRIBUTED TO ANTERIOR LEAFLET DAMAGE. A FURTHER ATTEMPT AT GRASPING AND CAPTURING WAS MADE USING A MITRACLIP XTW; HOWEVER, THIS WAS UNSUCCESSFUL. THE CLIPS WERE REMOVED FROM THE ANATOMY, AND THE PROCEDURE WAS TERMINATED. THE MR WAS REDUCED TO GRADE 3¿4 POST-PROCEDURE. NO CLINICALLY SIGNIFICANT DELAY WAS REPORTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 24807836 ↗
• MalfunctionApr 7, 2026Difficult or Delayed Positioning; Positioning Failure; Improper or Incorrect Procedure or Method; Device Damaged by Another Device; Difficult to Open or Close; Unintended Movement; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT PRESENTED WITH GRADE 4+ DEGENERATIVE MITRAL REGURGITATION (MR), ANTERIOR LEAFLET FLAIL WITH PROLAPSE (A1), CORONARY ARTERY DISEASE (CAD), HYPERTENSION (HTN), HYPERLIPIDEMIA (HLD), CHRONIC OBSTRUCTIVE PULMONARY DISEASE (CPOD), TRICUSPID REGURGITATION (TR), RIGHT BUNDLE BRANCH (RBB), TRANSIENT ISCHEMIC ATTACK (TIA) FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, FIRST LEAFLET GRASP WAS NOT CONVINCED OF FULL LEAFLET INSERTION, AND SECOND LEAFLET GRASP WAS WELL VISUALIZED, AND IT WAS DECIDED TO DEPLOY THE CLIP. CLIP WAS DEPLOYED AND SLIGHT LATERAL TO MEDIAL, CANT WAS NOTED. IT WAS PREVIOUSLY PLANNED TO IMPLANT THE SECOND MITRACLIP CENTRAL TO THE FIRST CLIP. AFTER IMPLANTING THE SECOND MITRACLIP, LATERAL JET HAD WORSENED AND IT WAS OBSERVED THAT THE ANTERIOR LEAFLET WAS VISIBLE OUTSIDE OF THE CLIP. IT WAS DECIDED TO IMPLANT THE ADDITIONAL CLIP LATERAL TO THE FIRST CLIP. THIRD MITRACLIP WAS DOWN IN THE VENTRICLE, GRASPING WAS COMPLETED AND FOUND THE ORIENTATION WAS NOT CORRECT. PHYSICIAN OPENED THE ARM, MISTAKENLY DID NOT LIFT THE GRIPPERS, TRIED TO ROTATE THE CLIP AND RESISTANCE WAS FELT. WHEN PHYSICIAN REALIZED THE MISTAKE, PHYSICIAN LIFT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24802024 ↗
• InjuryApr 6, 2026Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT PRESENTED WITH GRADE 4+ DEGENERATIVE MITRAL REGURGITATION (MR) 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. MR GRADE WAS 4+ AFTER THE SLDA. PATIENT RETURNED WITH SHORTNESS OF BREATH.

  Patient problems: Dyspnea; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 24793215 ↗
• MalfunctionMar 20, 2026Difficult to Open or Close

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT PRESENTED WITH GRADE 4 DEGENERATIVE MITRAL REGURGITATION (MR) AND MITRAL ANNULAR CALCIFICATION ON POSTERIOR SIDE OF THE VALVE FOR A MITRACLIP PROCEDURE. DURING THE PREPARATION, ONE OF THE GRIPPERS WOULD NOT FULLY LOWER ONTO THE CLIP ARM. DEVICE WAS REPLACED AND CONTINUED THE PROCEDURE. 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 24653705 ↗
• InjuryMar 2, 2026Difficult or Delayed Positioning; Entrapment of Device; Difficult to Open or Close; Expulsion; Unintended Movement

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT PRESENTED WITH GRADE 4+ DEGENERATIVE MITRAL REGURGITATION (MR), PROLAPSED POSTERIOR LEAFLET AT P1 AND P2, POSTERIOR LEAFLET FLAIL AT P3, PROLAPSED ANTERIOR LEAFLET AT A2 FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, MITRACLIP NT WAS IMPLANTED ON THE CENTRAL SIDE OF ANTERIOR AND POSTERIOR LEAFLET 3 (A3P3) AND THE SECOND MITRACLIP XTW WAS IMPLANTED ON THE LATERAL SIDE OF ANTERIOR AND POSTERIOR LEAFLET 2 (A2P2). PHYSICIAN DECIDED TO PLACE ANOTHER THIRD MITRACLIP NT ON THE MEDIAL SIDE OF ANTERIOR AND POSTERIOR LEAFLET 3 (A3P3). THIRD CLIP WAS STEERED OVER THE VALVE, AND THE POSTERIOR LEAFLET WAS CAUGHT AT THE GRIPPER, AND INTERACTED WITH THE FLAIL CHORDAE, TRIED REMOVING THE STUCK POSTERIOR LEAFLET, BUT WAS UNSUCCESSFUL. IT WAS DECIDED TO GRASP THE LEAFLETS, AND IT WAS OBSERVED THAT THE GRIPPERS WOULD NOT LOWER AND RAISE. TROUBLESHOOTING WAS PERFORMED BUT WAS UNSUCCESSFUL IN LOWERING THE GRIPPERS. WHILE GRIPPERS IN RAISED POSITION, PHYSICIAN ATTEMPTED AS MUCH LEAFLET AS POSSIBLE IN CLIP ARMS AND CLOSED THE CLIP. MITRACLIP NT WAS IMPLANTED. ONCE CLIP WAS DEPLOYED, IT WAS FREED FROM THE CHORDAE. AFTER FEW HEARTBEATS, MITRACLIP NT WAS EMBO

  Patient problems: Embolism/Embolus

  MAUDE report 24489641 ↗
• MalfunctionFeb 27, 2026Difficult to Open or Close

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT PRESENTED WITH GRADE 4 FUNCTIONAL MITRAL REGURGITATION (MR) AND MALCOAPTATION FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, ONE OF THE GRIPPERS WOULD NOT LOWER. THE FINAL MR WAS GRADE 2. ALL STEPS WERE PERFORMED AS PER IFU. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24470341 ↗
• InjuryFeb 23, 2026Entrapment of Device

  N/A.

  Patient problems: Mitral Valve Stenosis

  MAUDE report 24420288 ↗
• MalfunctionFeb 12, 2026Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT PRESENTED WITH GRADE 4 DEGENERATIVE MITRAL REGURGITATION (MR) AND PROLAPSED POSTERIOR LEAFLET FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, FIRST MITRACLIP WAS IMPLANTED AND DECIDED TO GO FOR THE SECOND CLIP TO FURTHER REDUCE THE MR. WHEN THE SECOND CLIP WAS DEPLOYED, A SINGLE LEAFLET DETACHMENT (SLDA) OCCURRED, AND THE CLIP WAS NO LONGER ATTACHED TO THE POSTERIOR LEAFLET. IMAGING WAS DIFFICULT. 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 24326635 ↗
• InjuryJan 29, 2026Incomplete Coaptation

  N/A.

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

  MAUDE report 24210438 ↗