MITRACLIP CDS0601-XTRRecalls & reported problems

Summary

The FDA's MAUDE database contains 873 adverse event reports that list this exact device (DI 08717648226366), received between Oct 10, 2018 and Jul 31, 2026 — classified as 30 deaths, 612 injuries, 231 malfunctions.

The most frequently reported specific device problem is “Incomplete Coaptation” (343 reports).

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Sep 8, 2022Open, Classified

   An increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked, have been observed. Contributing causes may be clip locking component material properties and certain use conditions. Unsuccessful clip procedure can lead to recurrence of severe mitral regurgitation, device embolization, or tissue injury.

   Z-0115-2023 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 873 reports, in the reporter's own words as published by the FDA.

• InjuryJul 31, 2026Entrapment of Device

  It was reported that on (b)(6)2026, a patient presented with grade 5 degenerative mitral regurgitation (MR) and a prolapsed posterior leaflet for a MitraClip procedure. During the procedure, a MitraClip was advanced within the patient. While positioning the clip it became caught on the chordae tendinea. Troubleshooting was performed and the clip remained entraped on the leaflets when tissue damage was visualized. The procedure was discontinued, the MR remained at grade 5. There were no clinically significant delays reported.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 50101260 ↗
• InjuryJul 20, 2026Adverse Event Without Identified Device or Use Problem

  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, a MitraClip was advanced within the patient. During grasping attempts the MitraClip XTR caused a tear on the posterior leaflet. The Mitraclip was removed from the patient and the procedure was discontinued without implanting any MitraClips. The final MR remained at grade 4+. There were no clinically significant delays reports.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 25871292 ↗
• InjuryJun 3, 2026Incomplete Coaptation

  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, TWO MITRACLIPS WERE IMPLANTED SUCCESSFULLY. THE PROCEDURE WAS DISCONTINUED, THE FINAL MR WAS REDUCED TO GRADE 1. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED. IT WAS REPORTED THAT ON (B)(6) 2026, A FOLLOW-UP ECHOCARDIOGRAM WAS PERFORMED AND IT WAS IDENTIFIED THAT THE PATIENTS MR HAD INCREASED TO GRADE 3. THE PATIENT WAS TRANSITIONED INTO A PROCEDURE FOR A SECONDARY MITRACLIP PROCEDURE. DURING THE PROCEDURE, IT WAS IDENTIFIED THAT ONE OF THE PREVIOUSLY IMPLANTED CLIP HAD A SINGLE LEAFLET DETACHMENT (SLDA) AND WAS NO LONGER ATTACHED TO THE ANTERIOR LEAFLET. AN ADDITIONAL CLIP WAS IMPLANTED BESIDE THE SLDA CLIP FOR STABILIZATION. 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: Mitral Valve Insufficiency/ Regurgitation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25382848 ↗
• InjuryApr 21, 2026Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2026, A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 4+ ON A PATIENT WITH A PROLAPSED POSTERIOR LEAFLET, THICK LEAFLETS, A CALCIFIED VALVE ANNULUS, AND A PREVIOUS TRANSCATHETER AORTIC VALVE IMPLANT (TAVI) SURGERY. A STEERABLE GUIDE CATHETER (SGC) AND A MITRACLIP XTR WERE INSERTED WITHOUT ISSUES. HOWEVER, LIMITED BENDING MANIPULATION WITH THE SGC OCCURRED, WHICH RESULTED IN DIFFICULTY WITH POSITIONING OF THE SGC AND UNEVEN CLAMPING WITH THE MITRACLIP XTR. THE MITRACLIP XTR WAS ULTIMATELY DEPLOYED ON THE MITRAL VALVE, REDUCING MR TO A GRADE OF 1+. AFTER THE SGC WAS REMOVED FROM THE PATIENT, THE SGC WAS TESTED AND THE SGC TIP WAS BENDING NORMALLY. ON (B)(6) 2026, ONE WEEK POST PROCEDURE, THE PATIENT DEVELOPED CHEST TIGHTNESS. AN ULTRASOUND WAS PERFORMED AND REVEALED THAT THE CLIP 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+. THE PATIENT WAS REPORTED TO BE STABLE.

  Patient problems: Angina; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 24942067 ↗
• InjuryApr 16, 2026Unintended Movement

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT PRESENTED WITH MITRAL REGURGITATION (MR) FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, A MITRACLIP WAS SUCCESSFULLY PLACED ON THE LEAFLETS AND DEPLOYED. AFTER DEPLOYMENT, THE CLIP OPENED TO APPROXIMATELY 30 DEGREES. THE PROCEDURE WAS DISCONTINUED. THERE WERE NO ADVERSE PATIENT SEQUELA OR CLINICALLY SIGNIFICANT DELAYS REPORTED. ON (B)(6) 2026, A TRANSTHORACIC ECHOCARDIOGRAM (TTE) WAS PERFORMED ON THE PATIENT AND IT WAS IDENTIFIED THAT THE MR RETURNED. THE PATIENT'S HEART RATE AND BLOOD PRESSURE REMAINED STABLE, THE PATIENT WAS TREATED WITH MEDICATION AND REMAINS HOSPITALIZED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 24905174 ↗
• MalfunctionApr 14, 2026Difficult to Open or Close

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT PRESENTED WITH MITRAL REGURGITATION (MR) FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, THERE WAS A LEAK IN THE STEERABLE GUIDE CATHETER (SGC) FROM THE HEMOSTASIS VALVE. THE SGC WAS REMOVED FROM THE PROCEDURE AND A REPLACEMENT SGC WAS SELECTED. A MITRACLIP WAS ADVANCED WITHIN THE PATIENT AND ATTEMPTED TO BE PLACED ON THE LEAFLETS. IT WAS IDENTIFIED THAT THE POSTERIOR LEAFLET WOULD NOT DESCEND. TROUBLESHOOTING WAS PERFORMED UNSUCCESSFULLY AND THE CLIP WAS ATTEMPTED TO BE REMOVED FROM THE PROCEDURE. IT WAS NOT POSSIBLE TO REMOVE THE CLIP AND THE PATIENT WAS CONVERTED TO SURGERY. THERE WERE NO CLINICALLY SIGNIFICANT DELAYS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24873587 ↗
• MalfunctionApr 8, 2026Leak/Splash

  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, A MITRACLIP WAS ADVANCED WITHIN THE STEERABLE GUIDE CATHETER (SGC) WHEN AIR BUBBLES WERE VISUALIZED WITHIN THE SGC. TROUBLESHOOTING WAS PREFORMED AND IT WAS IDENTIFIED THAT THE HEMOSTATIC VALVE WAS DAMAGED. THE MITRACLIP AND SGC WAS REMOVED FROM THE PATIENT, REPLACEMENT DEVICES WERE SELECTED. THE REPLACEMENT MITRACLIP WAS SUCCESSFULLY IMPLANTED. THE FINAL MR WAS REDUCED TO <1. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24821755 ↗
• InjuryJan 29, 2026Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2026, A PATIENT PRESENTED WITH GRADE 4+ MIXED MITRAL REGURGITATION (MR), THICK LEAFLETS WITH SEVERE REFLUX AND EXTENSIVE PROLAPSE FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, A MITRACLIP WAS IMPLANTED AND THE REFLUX WAS CONTROLLED. 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 HAS OCCURRED AND CLIP WAS NO LONGER ATTACHED TO POSTERIOR LEAFLET AND MR HAS INCREASED AND PATIENT RETURNED WITH CONGESTIVE HEART FAILURE (CHF). SURGICAL TREATMENT OF THORACOTOMY AND MITRAL VALVE REPLACEMENT WAS PERFORMED ON (B)(6) 2026.

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

  MAUDE report 24214743 ↗
• InjuryJan 15, 2026Difficult or Delayed Positioning; Incomplete Coaptation

  N/A.

  Patient problems: Angina; Dyspnea; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 24081831 ↗
• InjuryJan 12, 2026Incomplete Coaptation; Unintended Movement

  IT WAS REPORTED ON (B)(6) 2025 THAT THE PATIENT PRESENTED WITH GRADE 4 MIXED MITRAL REGURGITATION (MR), RESTRICTED AND FLAIL ANTERIOR LEAFLET FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, PLUS KNOB WAS UNABLE TO RESPOND DUE TO THE MECHANICAL JAM. AN ATTEMPT WAS MADE TO DEPLOY THE CLIP. THE CLIP OPENED TO 60 DEGREE POST DEPLOYMENT AND HAD SINGLE LEAFLET DEVICE ATTACHMENT(SLDA) FROM THE POSTERIOR LEAFLET. CHORDAL RUPTURE WAS OBSERVED. THE MR REMAINED UNCHANGED POST PROCEDURE. THE PATIENT WAS REFERRED FOR THORACIC SURGERY. THERE WAS NO CLINICALLY SIGNIFICANT DELAY.

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

  MAUDE report 24041173 ↗
• MalfunctionJan 5, 2026Incomplete Coaptation

  IT WAS REPORTED ON (B)(6) 2025 THAT THE PATIENT PRESENTED WITH GRADE 4+ FUNCTIONAL MITRAL REGURGITATION (MR), TWO VENTRICULAR ANEURYSMS AND CARDIAC TRANSPOSITION FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, IMAGING WAS DIFFICULT. ONE MITRACLIP WAS SUCCESSFULLY IMPLANTED. DURING DEPLOYMENT OF SECOND MITRACLIP, PARTIAL CLIP DETACHMENT FROM ANTERIOR LEAFLET WAS OBSERVED. THE PROCEDURE WAS TERMINATED WITH REMOVAL OF THE SECOND CLIP AND NO CHANGE IN MR POST PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23956556 ↗
• InjuryDec 24, 2025Positioning Failure; Entrapment of Device; Incomplete Coaptation; Positioning Failure; Entrapment of Device; Incomplete Coaptation

  IT WAS REPORTED THAT A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) WITH A GRADE OF 4, LARGE GAP, AND ENLARGED ATRIUM. A MITRACLIP XTR WAS INSERTED AND DEPLOYED ON THE MITRAL VALVE. A SECOND CLIP, A MITRACLIP XTR (50717R1017) WAS INSERTED AND ADVANCED UNDER THE VALVE. HOWEVER, DIFFICULTIES CAPTURING THE ANTERIOR AND POSTERIOR LEAFLETS OCCURRED, THE CLIP BECAME CAUGHT IN CHORDAE. TROUBLESHOOTING WAS PERFORMED, AND THE CLIP WAS UNABLE TO BE FREED FROM CHORDAE. THEREFORE, THE CLIP WAS DEPLOYED WHERE IT WAS STUCK, ATTACHED TO THE ANTERIOR LEAFLET AND DETACHED FROM THE POSTERIOR LEAFLET (SINGLE LEAFLET DEVICE ATTACHMENT/SLDA). NO ADDITIONAL CLIPS WERE IMPLANTED, AND THE MR REMAINED AT A GRADE OF 4. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 23889694 ↗
• InjuryDec 22, 2025Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2025, A PATIENT PRESENTED WITH GRADE 4+ MIXED MITRAL REGURGITATION (MR), PROLAPSED ANTERIOR LEAFLET, THIN AND FRIABLE LEAFLETS FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, TWO MITRACLIPS WERE IMPLANTED SUCCESSFULLY. THE FINAL MR WAS GRADE 1+. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED. ON (B)(6) 2025, CARDIAC AUSCULTATION REVEALED A MURMUR AT THE MITRAL VALVE AREA. ECHOCARDIOGRAPHY WAS DONE AND IT WAS DETERMINED THAT SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) HAS OCCURRED WITH ONE OF THE MITRACLIP DEVICES THAT HAD BEEN IMPLANTED AND MITRACLIP HAD DETACHED FROM THE POSTERIOR LEAFLET. MR WAS GRADE 4+ AFTER SLDA. IT WAS NOTED THAT THE PATIENT REQUIRED SURGICAL PROCEDURE FOR VALVE REPLACEMENT AND REMOVAL OF THE MITRACLIP. IT WAS NOTED THAT ON 01 DECEMBER 2025 DURING MORNING ROUNDS, THE PATIENT WAS ALERT AND IN STABLE CONDITION. PER THE PHYSICIAN, THE CAUSE OF THE SLDA WAS DETERMINED TO HAVE BEEN RELATED TO PRE-EXISTING PATIENT ANATOMY OF THIN AND FRIABLE LEAFLETS.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 23871226 ↗
• InjuryDec 10, 2025Incomplete Coaptation; Device Damaged by Another Device; Incomplete Coaptation; Device Damaged by Another Device

  IT WAS REPORTED THAT ON (B)(6) 2025, A PATIENT PRESENTED WITH GRADE 4 DEGENERATIVE MITRAL REGURGITATION FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE A MITRACLIP XTR WAS SUCCESSFULLY IMPLANTED ON THE ANTERIOR-3/POSTERIOR-3 (A3/P3) LEAFLET SEGMENT. A SECOND MITRACLIP NTR WAS ADVANCED TO FURTHER REDUCE MR. THE SECOND CLIP HAD CHALLENGES CAPTURING THE LEAFLETS AND CAUSED THE FIRST CLIP TO HAVE A SINGLE LEAFLET DETACHMENT (SLDA). THE PROCEDURE WAS DISCONTINUED AND THE PATIENT UNDERWENT A SURGICAL MITRAL VALVE REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23767053 ↗
• InjuryNov 17, 2025Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2025, A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 4 AND PROLAPSED POSTERIOR LEAFLET. A STEERABLE GUIDE CATHETER (SGC) AND A MITRACLIP XTR WAS INSERTED WITHOUT ISSUES. IT WAS NOTED THAT DURING THE PROCEDURE, DURING MANIPULATION OF THE SGC, THERE WAS INSUFFICIENT SENSITIVITY, PREVENTING PRECISE CONTROL. GRASPING WAS PERFORMED WITH THE MITRACLIP XTR. HOWEVER, THE CLIP WAS UNABLE TO FIRMLY GRASP THE LEAFLETS. THE CLIP WAS ULTIMATELY IMPLANTED. TO FURTHER DECREASE MR, A SECOND CLIP, A MITRACLIP XTR WAS INSERTED AND DEPLOYED ON THE MITRAL VALVE, REDUCING MR TO A GRADE OF 1-2. ON (B)(6) 2025, AN ECHOCARDIOGRAM WAS PERFORMED AND REVEALED THAT THE CLIP HAD DETACHED FROM ONE LEAFLET AND REMAINED ATTACHED TO THE OTHER LEAFLET (SINGLE LEAFLET DEVICE ATTACHMENT/SLDA), CAUSING MR TO INCREASE.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 23569469 ↗
• InjuryNov 13, 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 5, EJECTION FRACTION OF 21%, AND CARDIAC TRANSPOSITION. THREE MITRACLIPS WERE INSERTED AND DEPLOYED ON THE MITRAL VALVE, REDUCING MR TO A GRADE OF 1.5+. ON (B)(6) 2025, A FOLLOW UP ULTRASOUND WAS PERFORMED AND REVEALED A POSTERIOR MITRAL LEAFLET PERFORATION CAUSED BY THE FIRST CLIP. THE MITRACLIP XTR (50605R1031). THE XTR HAD DETACHED FROM THE ANTERIOR LEAFLET AND REMAINED ATTACHED TO THE POSTERIOR LEAFLET (SINGLE LEAFLET DEVICE ATTACHMENT/SLDA), CAUSING MR TO INCREASE TO A GRADE OF 4+.

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

  MAUDE report 23547930 ↗
• InjuryNov 4, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT ON (B)(6) 2025, A PATIENT PRESENTED WITH GRADE 3-4 FUNCTIONAL MITRAL REGURGITATION (MR) FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, A MITRACLIP XTR WAS ATTEMPTED TO BE PLACED BUT WAS UNABLE TO ADEQUATELY GRASP THE LEAFLETS. TROUBLESHOOTING WAS PREFORMED AND MULTIPLE GRASPING ATTEMPTS WERE MADE WHEN IT WAS IDENTIFIED THAT THE LEAFLET TISSUE HAD BEEN DAMAGED. THE CLIP WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS DISCONTINUED. THE FINAL MR REMAINED AT GRADE 3-4. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 23468136 ↗
• InjuryNov 4, 2025Incomplete Coaptation; Incomplete Coaptation

  N/A.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 23467723 ↗
• InjuryAug 18, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 4+ AND PROLAPSED POSTERIOR LEAFLET. A MITRACLIP XTR WAS INSERTED, ADVANCED INTO THE LEFT VENTRICLE (LV), AND GRASPING WAS PERFORMED. HOWEVER, DIFFICULTIES VISUALIZING THE CLIP OCCURRED, AND THE CLIP BECAME CAUGHT IN CHORDAE. TROUBLESHOOTING WAS PERFORMED, AND THE CLIP WAS FREED. HOWEVER, CHORDAE RUPTURE AND LEAFLET DAMAGE WERE OBSERVED. THEREFORE, THE CLIP WAS REMOVED FROM THE PATIENT. HOWEVER, AFTER REMOVING THE STEERABLE GUIDE CATHETER (SGC), IT WAS OBSERVED THAT THE INTERATRIAL SEPTUM WAS DAMAGED. THE PROCEDURE WAS DISCONTINUED. NO CLIPS WERE IMPLANTED, AND THE MR REMAINED AT A GRADE OF 4+. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22829692 ↗
• DeathAug 15, 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) GRADE 4+. PATIENT HAD DILATED CARDIOMYOPATHY, LEFT VENTRICULAR END-SYSTOLIC DIAMETER 70MM, AND POSTERIOR LEAFLET RESTRICTION. A XTR CLIP WAS IMPLANTED REDUCING MR TO GRADE 1+. FIVE DAYS AFTER THE PROCEDURE (B)(6) 2025, THE PATIENT DIED FROM CEREBRAL HEMORRHAGE. THERE WERE NO REPORTED DEVICE ISSUE WITH THE XTR OR THE STEERABLE GUIDE CATHETER DURING THE INITIAL PROCEDURE. POST PROCEDURE THE CLIP WAS REPORTED TO REMAIN STABLE ON BOTH LEAFLETS AND NO TISSUE DAMAGE WAS OBSERVED. THE CAUSE OF THE CEREBRAL HEMORRHAGE WAS REPORTED TO BE UNKNOWN.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 22815722 ↗
• InjuryAug 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2025, A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT MIXED MITRAL REGURGITATION (MR) WITH A GRADE OF 4+. TWO CLIPS WERE IMPLANTED. HOWEVER, MR REMAINED UNCHANGED POST-PROCEDURE. ON (B)(6) 2025, AT A FOLLOW-UP APPOINTMENT, MR SHOWED NO SIGNS OF IMPROVEMENT AND TISSUE DAMAGE OBSERVED.

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

  MAUDE report 22741838 ↗
• InjuryAug 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2025, A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT MIXED MITRAL REGURGITATION (MR) WITH A GRADE OF 4+. TWO CLIPS WERE IMPLANTED. HOWEVER, MR REMAINED UNCHANGED POST-PROCEDURE. ON (B)(6) 2025, AT A FOLLOW-UP APPOINTMENT, MR SHOWED NO SIGNS OF IMPROVEMENT AND TISSUE DAMAGE OBSERVED.

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

  MAUDE report 22741634 ↗
• InjuryJul 25, 2025Difficult or Delayed Positioning; Incomplete Coaptation; Difficult or Delayed Positioning; Incomplete Coaptation

  IT WAS REPORTED ON (B)(6) 2025 THAT THE PATIENT WAS PRESENTED WITH GRADE 4+ DEGENERATIVE MITRAL REGURGITATION (MR), SMALL CARDIAC CHAMBERS AND PROLAPSED POSTERIOR LEAFLET FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, A SINGLE LEAFLET DEVICE ATTACHMENT AND ATRIAL SEPTAL INJURY WAS OBSERVED REQUIRING SURGICAL INTERVENTION. THE MR REMAINED UNCHANGED POST PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY.

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

  MAUDE report 22607799 ↗
• InjuryJul 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THIS WAS A MITRACLIP PROCEDURE TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) WITH A GRADE OF 4+. WHILE ADJUSTING THE TRAJECTORY, INSUFFICIENT HEIGHT WAS ENCOUNTERED. DRAWING FROM OPERATIONAL EXPERIENCE, THE - KNOB WAS USED TO COMPENSATE FOR THE HEIGHT DEFICIENCY. SUBSEQUENTLY, THE CLIP CAME INTO CONTACT WITH THE ATRIAL WALL. AFTER A BRIEF OBSERVATION PERIOD, A PERICARDIAL EFFUSION WAS IDENTIFIED IN THE PATIENT. THE PHYSICIAN IMMEDIATELY HALTED THE PROCEDURE AND WITHDREW THE STEERABLE GUIDE CATHETER (SGC) AND CLIP DELIVERY SYSTEM (CDS). THE PHYSICIAN SUSPECTS THAT THE¿-¿¿ KNOB OF SGC EXHIBITED ABNORMAL TORQUE, CAUSING PERICARDIAL INJURY. THE PATIENT WAS SUBSEQUENTLY TRANSFERRED FOR SURGICAL INTERVENTION.

  Patient problems: Pericardial Effusion

  MAUDE report 22387588 ↗
• InjuryJul 2, 2025Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2025, A PATIENT PRESENTED WITH GRADE 4+ MIXED MITRAL REGURGITATION (MR) FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, A MITRACLIP WAS IMPLANTED SUCCESSFULLY. THERE WERE NO CLINICALLY SIGNIFICANT DELAYS OR ADVERSE PATIENT EFFECTS. 10 DAYS POST PROCEDURE, THE PATIENT RETURNED SYMPTOMATIC WITH CHEST TIGHTNESS AND RETURNED REFLUX. SURGICAL INTERVENTION WAS PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Angina

  MAUDE report 22383693 ↗