MITRACLIP CDS0701-XTRecalls & reported problems

Summary

The FDA's MAUDE database contains 271 adverse event reports that list this exact device (DI 08717648230981), received between Jan 22, 2020 and Feb 2, 2026 — classified as 6 deaths, 144 injuries, 121 malfunctions.

The most frequently reported specific device problem is “Incomplete Coaptation” (76 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 271 reports, in the reporter's own words as published by the FDA.

• DeathFeb 2, 2026Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2020, A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 4 AND PRE-EXISTING POSTERIOR FLAIL. A MITRACLIP XTW WAS INSERTED AND DEPLOYED MEDIALLY ON THE MITRAL VALVE. A SECOND MITRACLIP, A MITRACLIP XT, WAS THEN INSERTED AND DEPLOYED ON THE MITRAL VALVE, LATERAL TO THE FIRST CLIP, REDUCING MR TO A GRADE OF 1-2. IT WAS NOTED THAT THE CLIPS APPEARED TO BE STABLE. ON (B)(6) 2026, AN ECHOCARDIOGRAM WAS PERFORMED AND REVEALED A POSTERIOR FLAIL THAT THE MITRACLIP XT 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. IT WAS NOTED THAT IT WAS UNCERTAIN IF THE MITRACLIP XT HAD WORSENED THE POSTERIOR FLAIL. DUE TO DECLINING HEALTH, THE PATIENT URGENTLY UNDERWENT A SECOND MITRACLIP PROCEDURE ON THE SAME DAY. ONE CLIP WAS IMPLANTED, AND THE MR REMAINED AT A GRADE OF 4. IT WAS NOTED THAT THE PATIENT REQUIRED HOSPITALIZATION. ON (B)(6) 2026, THE PATIENT PRESENTED TO THE HOSPITAL IN HEART FAILURE, REQUIRING A BALLOON PUMP AND OTHER SUPPORTS. THE PATIENT DIED. IN THE PHYSICIAN'S OPINION, THE CAUSE OF DEATH

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

  MAUDE report 24234854 ↗
• InjuryDec 19, 2024Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT ON (B)(6) 2022, A PATIENT PRESENTED WITH GRADE 4+ DEGENERATIVE MITRAL REGURGITATION (MR), TRICUSPID REGURGITATION, INSULIN-DEPENDENT DIABETES MELLITUS (IDDM), CARDIOMYOPATHY, HISTORY OF CORONARY ARTERY BYPASS GRAFT (CABG), CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) AND A POSTERIOR 2 PROLAPSE. THREE CLIPS WERE IMPLANTED, TWO XTWS AND AN XT. THE MR WAS REDUCED TO GRADE 1+. ON (B)(6) 2023, THE PATIENT RETURNED SYMPTOMATIC WITH GRADE 4+ MR, FATIGUE, AND SHORTNESS OF BREATH. AN ECHOCARDIOGRAM WAS PERFORMED, DISPLAYING THE CENTRAL XT CLIP OPENED TO APPROXIMATELY 50 DEGREES. THE XT WAS STABLE BETWEEN THE 2 XTW CLIPS THAT WERE PLACED LATERAL TO EACH SIDE. ON (B)(6) 2023 THE CLIPS WERE SURGICALLY EXPLANTED AND A VALVE REPLACEMENT WAS PERFORMED. ON (B)(6) 2024, A PRESENTATION OF THE PROCEDURE WAS PERFORMED BY DR. (B)(6). THE CLIPS WERE SURGICALLY EXPLANTED. THE XT CLIP ARMS WERE OPENED TO APPROXIMATELY 50 DEGREES. IT WAS HYPOTHESIZED THAT THE TENSION FROM THE VALVE LEAFLET AND FAILURE OF THE CLIP LOCKING MECHANISM CONTRIBUTED TO THE OPENING OF THE XT. DURING THE PRESENTATION, THE OPENED CLIP WAS INCORRECTLY LABELED AS AN XTW. IT WAS CONFIRMED BY THE IMPLANTER THAT THE

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

  MAUDE report 20977477 ↗
• InjuryJan 10, 2024Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2022, A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT A FUNCTIONAL MITRAL REGURGITATION (MR) WITH GRADE OF 2-3. ONE CLIP WAS IMPLANTED, REDUCING MR TO GRADE 2. SOMETIME IN NOVEMBER 2023, A FOLLOW-UP IMAGING WAS PERFORMED, AND THE CLIP WAS NOTED TO BE STABLE ON THE LEAFLETS. ON 15DEC2023, THE PATIENT WAS PRESENTED WITH SHORTNESS OF BREATH. TRANSTHORACIC ECHOCARDIOGRAM (TTE) WAS PERFORMED SHOWING THAT THE CLIP DETACHED FROM THE POSTERIOR LEAFLET (SINGLE LEAFLET DEVICE ATTACHMENT (SLDA), BUT WAS ONLY ATTACHED TO ONE CHORD AND THE ANTERIOR LEAFLET. LEAFLET DAMAGE WAS OBSERVED, AND MR WAS NOTED TO WORSEN TO GRADE 4+. THE PATIENT HAD INFECTION AND VIOLENT COUGHING, WHICH WAS THEORIZED BE WHAT MIGHT HAVE CAUSED THE SLDA. IN THE PHYSICIAN¿S OPINION, THE IMPLANTED CLIP DID NOT CAUSE OR CONTRIBUTE TO THE INFECTION. ON (B)(6) 2023, THE PATIENT UNDERWENT ADDITIONAL MITRACLIP PROCEDURE TO TREAT WHAT NOW IS A DEGENERATIVE MITRAL REGURGITATION (MR) WITH GRADE 4+. TWO CLIPS WERE IMPLANTED WITH NO REPORTED ISSUE, REDUCING MR TO GRADE 1-2. HOWEVER, THE PRESSURE GRADIENT INCREASED FROM PRE-PROCEDURAL 8MMHG TO 10MMHG. THE PHYSICIAN IS SATISFIED WITH THE RESULT DESPITE THE G

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

  MAUDE report 18484174 ↗
• InjuryDec 12, 2023Off-Label Use; Incomplete Coaptation; Off-Label Use; Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2021 A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT DEGENERATIVE TRICUSPID REGURGITATION (TR) GRADE 4. A MITRACLIP XT WAS PLACED OFF-LABEL SUCCESSFULLY, REDUCING TR TO GRADE 1-2. ON (B)(6) 2023 THE PATIENT RETURNED WITH RECURRENT SEVERE TR AND THE IMPLANTED CLIP DETACHED FROM ONE LEAFLET (SINGLE LEAFLET DEVICE ATTACHMENT (SLDA)). AN ADDITIONAL TRICLIP WAS PLACED TO STABILIZE, REDUCING TR TO MILD. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 18310639 ↗
• InjuryDec 1, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED THIS WAS A MITRACLIP PROCEDURE TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 4 AND A POSTERIOR PROLAPSE. ONE CLIP WAS INSERTED AND SUCCESSFULLY DEPLOYED ON THE MITRAL VALVE. TO FURTHER REDUCE MR, AN XT CLIP WAS INSERTED, AND GRASPING WAS PERFORMED. HOWEVER, GRASPING WAS NOTED TO BE DIFFICULT. A PERFORATION WAS THEN OBSERVED ON THE POSTERIOR LEAFLET; THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE CLIP AND DISCONTINUE THE PROCEDURE. MR WAS REDUCED TO A GRADE OF 2-3. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 18248525 ↗
• InjuryNov 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBSEQUENT TO THE INITIAL REPORT, THE ADDITIONAL INFORMATION AS RECEIVED: IT WAS REPORTED THAT ON (B)(6) 2021, A MITRACLIP PROCEDURE WAS PERFORMED FOR SEVERE DEGENERATIVE MITRAL REGURGITATION (MR) WITH A MYXOMATOUS BARLOW MITRAL VALVE AND PROLAPSED LEAFLETS. TWO MITRACLIPS (XTW AND XT) WERE IMPLANTED WITHOUT A DEVICE ISSUE REPORTED, REDUCING THE MR TO MILD-MODERATE. THE PROCEDURE WAS DEEMED SUCCESSFUL WITHOUT COMPLICATIONS.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 18179118 ↗
• InjuryOct 11, 2023Incomplete Coaptation; Incomplete Coaptation

  THIS IS FILED TO REPORT INCOMPLETE COAPTATION AND TISSUE DAMAGE IT WAS REPORTED THAT A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) WITH GRADE 4. A MITRACLIP XTW WAS IMPLANTED AT A2/P2 WITHOUT ISSUES. A MITRACLIP XT WAS IMPLANTED ON A3/P3. HOWEVER, AFTER DEPLOYMENT IT WAS OBSERVED THE CLIP DETACHED FROM THE POSTERIOR LEAFLET AFTER DEPLOYMENT, SEVERE MR WAS NOTICED ON THE MEDIAL SIDE OF THE FIRST CLIP AND GOING THROUGH POSTERIOR LEAFLET AND REMAINED ATTACHED TO THE ANTERIOR LEAFLET (SINGLE LEAFLET DEVICE ATTACHMENT/SLDA). THIS RESULTED IN A TEAR OF THE POSTERIOR LEAFLET AND MR RETURNING TO A GRADE OF 4. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 17916779 ↗
• MalfunctionOct 6, 2023Unintended Movement; Unintended Movement

  THIS IS FILED TO REPORT A CLIP THAT OPENED DURING 'ESTABLISH FINAL ARM ANGLE' (EFAA). IT WAS REPORTED THAT A PATIENT PRESENTED WITH GRADE 4 DEGENERATIVE MITRAL REGURGITATION (MR), A PROLAPSED POSTERIOR MITRAL LEAFLET, AND A POSTERIOR 2 FLAIL FOR A MITRACLIP PROCEDURE. THE TARGET WAS ANTERIOR 2 AND POSTERIOR 2 LEAFLETS (A2/P2). THE DEVICE WAS PREPARED AND OPERATED PER INSTRUCTIONS FOR USE (IFU) AND PASSED FUNCTION INSPECTION DURING PREP. THE SECOND CLIP WAS PLACED MEDIALLY TO THE XTW ON A2/P2. DURING INITIAL 'ESTABLISH FINAL ARM ANGLE' (EFAA), THE CLIP SLIGHTLY OPENED. THE SECOND CLIP WAS UNLOCKED, OPENED TO 60 DEGREES, AND RELOCKED TO TROUBLESHOOT. EFAA WAS REPEATED AND THE CLIP SLIGHTLY RELAXED AGAIN, BUT THERE WAS NO CHANGE TO MR (OPENING NOTICED WAS NOTICED ON FLUOROSCOPY). THE CLIP WAS IMPLANTED, AND THE MR WAS REDUCED TO GRADE 1-2. PER THE PHYSICIAN, THE DEVICE SETTLED. THE CLIP WAS STABLE ON THE LEAFLETS. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17886564 ↗
• InjurySep 18, 2023Device Damaged by Another Device; Expulsion; Migration; Device Damaged by Another Device; Expulsion; Migration

  THIS IS FILED TO REPORT MIGRATION, EXPULSION, DEVICE DISLODGEMENT, AND EMBOLISM IT WAS REPORTED ON AN UNKNOWN DATE, A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) WITH AN UNKNOWN GRADE. ONE CLIP WAS SUCCESSFULLY IMPLANTED, REDUCING MR TO AN UNKNOWN GRADE. DURING A SCHEDULED FOLLOW-UP, ECHOCARDIOGRAPHY WAS PERFORMED AND IT WAS OBSERVED THE IMPLANTED CLIP HAD MOVED ON THE LEAFLETS, CAUSING MR TO INCREASE TO A GRADE OF 4. ON (B)(6) 2023 A SECOND MITRACLIP PROCEDURE WAS PERFORMED, TO TREAT THE RECURRENT MR. WHILE IMPLANTING AN ADDITIONAL CLIP, THE CLIP CAME IN CONTACT WITH THE IMPLANTED CLIP, CAUSING THE IMPLANTED CLIP TO DETACH FROM BOTH LEAFLETS AND EMBOLIZED. A SNARE WAS THEN INSERTED AND THE EMBOLIZED CLIP WAS SUCCESSFULLY REMOVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Embolism/Embolus; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 17765677 ↗
• InjurySep 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS FILED TO REPORT RECURRENT MITRAL REGURGITATION. IT WAS REPORTED THAT ON (B)96) 2023, A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 4. TWO CLIPS WERE DEPLOYED ON THE MITRAL VALVE, REDUCING MR TO A GRADE OF 1. AT THE ONE MONTH FOLLOW UP, ECHOCARDIOGRAPHY SHOWED MR HAD SLIGHTLY INCREASED TO A GRADE OF 1-2. ROUGHLY FIVE MONTHS LATER, AN ADDITIONAL FOLLOW UP ECHOCARDIOGRAPHY SHOWED MR HAD INCREASED TO A GRADE OF 4. IT WAS NOTED THAT BOTH CLIPS REMAINED STABLE ON BOTH LEAFLETS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 17750716 ↗
• MalfunctionJul 6, 2023Positioning Failure; Improper or Incorrect Procedure or Method; Positioning Failure; Improper or Incorrect Procedure or Method

  N/A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17267165 ↗
• MalfunctionJun 6, 2023Difficult to Open or Close; Unintended Movement; Difficult to Open or Close; Unintended Movement

  THIS WILL BE FILED TO REPORT A CLIP THAT FAILED TO ESTABLISH FINAL ARM ANGLE (EFAA). IT WAS REPORTED THAT DURING DEVICE PREPARATION OF A MITRACLIP PROCEDURE, THE XT CLIP FAILED EFAA. THE CLIP JUMPED OPENED ONE FULL TURN FROM CLOSED TO 60 DEGREES. THE CLIP WAS REPLACED WITH AN XTW TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVED AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17074292 ↗
• MalfunctionJun 5, 2023Difficult or Delayed Positioning; Difficult to Open or Close; Difficult or Delayed Positioning; Difficult to Open or Close

  THIS IS FILED TO REPORT INABILITY TO CLOSE A CLIP. IT WAS REPORTED THAT A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) WITH GRADE 4+ AND A RESTRICTED POSTERIOR LEAFLET. A MITRACLIP XTW WAS PLACED IN THE MEDIAL JET WITHOUT INCIDENT, REDUCING MR TO A GRADE OF 2-3. A MITRACLIP XT (20613R104) WAS THEN INSERTED, BUT AFTER GRASPING BOTH LEAFLETS AND ATTEMPTING TO CLOSE THE XT, THE CLIP WOULD NOT CLOSE. TROUBLESHOOTING WAS PERFORMED, BUT THE ISSUE WAS UNABLE TO BE RESOLVED. THEREFORE, THE CLIP WAS REMOVED. IN THE PHYSICIAN¿S OPINION, THE CLIPS LIMITED ABILITY TO CLOSE WAS LIKELY DUE TO THE CLIP CAUGHT IN CHORDAE. A MITRACLIP NTW (30109A1012) WAS THEN USED TO ADDRESS THE LATERAL JET, BUT BECAME CAUGHT IN THE CHORDAE, AND CAUSED AN INCREASE IN MR TO A GRADE OF 3-4. THE PHYSICIAN WAS UNABLE TO DETERMINE IF ANY TISSUE DAMAGE OCCURRED. THE CLIP WAS REMOVED AND REPLACED WITH AN XTW CLIP. THIS CLIP WAS SUCCESSFULLY IMPLANTED, REDUCING MR TO A GRADE OF 2. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17059370 ↗
• MalfunctionJun 5, 2023Difficult or Delayed Positioning; Unintended Movement; Difficult or Delayed Positioning; Unintended Movement

  THIS IS FILED TO REPORT THE CLIP OPENING AFTER DEPLOYMENT. IT WAS REPORTED THAT A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) GRADE 4. THE TRANSSEPTAL PUNCTURE WAS LOW, RESULTING IN DIFFICULTLY POSITIONING TOWARDS THE VALVE. THE FIRST CLIP WAS IMPLANTED SUCCESSFULLY. A SECOND XT (LOT: 21103R1035) CLIP WAS POSITIONED ON THE VALVE SUCCESSFULLY. AFTER DEPLOYMENT, THE XT (LOT: 21103R1035) CLIP OPENED FROM LESS THAN 10 DEGREES TO APPROXIMATELY 25 DEGREES. THE MR WAS STILL REDUCED TO GRADE 2 SO THE PROCEDURE WAS ENDED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17058666 ↗
• InjuryMay 8, 2023Incomplete Coaptation; Incomplete Coaptation

  THIS IS FILED TO REPORT SINGLE LEAFLET DEVICE ATTACHMENT (SLDA). IT WAS REPORTED THAT A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) GRADE 4 WITH A PROLAPSED POSTERIOR LEAFLET. AN XTW CLIP WAS IMPLANTED WITH NO REPORTED ISSUE. ANOTHER CLIP (XT) WAS IMPLANTED. AFTER DEPLOYMENT OF THE XT CLIP, A SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) WAS OBSERVED. THE CLIP HAD DETACHED FROM THE POSTERIOR LEAFLET. CHORDAE AND TISSUE DAMAGE WERE NOTED. IN THE PHYSICIAN¿S OPINION, THE SLDA WAS DUE TO THE PRE-EXISTING PATIENT ANATOMY. ADDITIONAL CLIP (NT) ATTEMPTED TO CORRECT MR. SLDA CLIP WAS NOT CONSIDERED UNSTABLE DESPITE DETACHING FROM POSTERIOR LEAFLET. THE ADDITIONAL CLIP DID NOT REDUCE MR AS INTENDED SO IT WAS REMOVED. MR REMAINED AT GRADE 4. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 16885589 ↗
• MalfunctionMay 4, 2023Unintended Movement; Unintended Movement

  THIS IS FILED TO REPORT UNINTENDED MOVEMENT. IT WAS REPORTED THAT A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH GRADE 4. A MITRACLIP XT WAS DEPLOYED LATERALLY BUT FOLLOWING DETACHMENT OF THE CLIP DELIVERY SYSTEM (CDS), THE CLIP WAS OBSERVED TO HAVE OPENED WHILE LOCKED (COWL) FROM 0 TO ABOUT 60 TO 70 DEGREES. THE CLIP WAS CONFIRMED TO BE STABLE ON BOTH LEAFLETS. A MITRACLIP XTW WAS THEN IMPLANTED. THE PROCEDURE WAS COMPLETED WITH TWO CLIPS IMPLANTED. THE MR WAS REDUCED TO GRADE 1+. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16873396 ↗
• InjuryApr 20, 2023Entrapment of Device; Premature Activation; Improper or Incorrect Procedure or Method; Unintended Movement; Entrapment of Device; Premature Activation; Improper or Incorrect Procedure or Method; Unintended Movement

  THIS IS FILED TO REPORT UNINTENDED MOVEMENT, PREMATURE DEPLOYMENT, DEVICE ENTRAPMENT, FOREIGN BODY, AND EMBOLISM. IT WAS REPORTED THAT A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) WITH GRADE 4 AND POOR LEAFLET TISSUE QUALITY. TWO MITRACLIPS WERE IMPLANTED WITHOUT ISSUES. AN XT CLIP WAS INSERTED AND ADVANCED INTO THE LEFT VENTRICLE (LV). IT WAS NOTED THE CLIP WAS NOT PROPERLY ALIGNED WHILE ADVANCING INTO THE LV. EXCESSIVE MOVEMENT OCCURRED WHILE IN THE LV, CAUSING THE CLIP TO BECOME CAUGHT IN CHORDAE. TROUBLESHOOTING WAS PERFORMED, BUT IT WAS OBSERVED THE CLIP HAD DETACHED FROM THE MANDREL. THE PHYSICIAN DECIDED TO REMOVE THE LOCK LINE (LL) AND DEPLOY THE CLIP IN THE CHORDAE. AFTER DEPLOYMENT, THE CLIP EMBOLIZED IN THE LEFT UPPER PULMONARY VEIN (PV). ONE ADDITIONAL CLIP WAS IMPLANTED, BUT MR REMAINED AT A GRADE OF 4. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 16782378 ↗
• InjuryApr 11, 2023Positioning Failure; Premature Activation; Positioning Failure; Premature Activation

  SUBSEQUENT TO THE REPORTED INFORMATION, IT WAS FURTHER REPORTED THAT THE CLIP INTERACTED WITH CHORDAE AND THERE WAS DIFFICULTY GRASPING EXPERIENCED. IT WAS ALSO NOTED THAT IMAGING WAS CHALLENGING THROUGHOUT THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 16714938 ↗
• MalfunctionApr 6, 2023Unintended Movement; Unintended Movement

  THIS IS FILED TO REPORT THE XT CLIP OPENING WHILE ESTABLISHING FINAL ARM ANGLE. IT WAS REPORTED THAT A MITRACLIP PROCEDURE WAS PERFORMED ON (B)(6) 2022 TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) GRADE 4. TWO MITRACLIP XTW'S (20510R307 AND 20511R166) WERE IMPLANTED SUCCESSFULLY, REDUCING MR TO GRADE 1-2. ON (B)(6) 2023, THE PATIENT RETURNED WITH RECURRENT MR GRADE 3-4 DUE TO PROGRESSION OF DISEASE. THERE WAS NO EVIDENCE OF TISSUE OR CHORDAL DAMAGE AND THE TWO IMPLANTED CLIPS WERE STILL STABLE ON THE LEAFLETS. AN ADDITIONAL NTW CLIP (20511R242) WAS IMPLANTED, REDUCING MR TO GRADE 2-3. ON (B)(6) 2023, THE PATIENT RETURNED WITH AN SLDA OF XTW CLIP (20510R307) AND WORSENED MR GRADE 4+. AN NTW CLIP (21013R1093) WAS POSITIONED IN THE VALVE. GRASPING AND CAPTURING THE LEAFLETS WERE NOTED TO BE DIFFICULT. AFTER MULTIPLE ATTEMPTS TO GRASP THE LEAFLETS, THE GRIPPERS BECAME STUCK. ONE WAS STUCK IN THE UPPER POSITION AND THE OTHER WAS STUCK IN THE DOWN POSITION. IT WAS THOUGHT CONTACT WAS MADE WITH A PREVIOUSLY IMPLANTED CLIP CAUSING THE GRIPPER ISSUE. TROUBLESHOOTING WAS PERFORMED, BUT THE ISSUE PERSISTED. THE CLIP WAS REMOVED AND EXCHANGED. A SECOND NTW CLIP (21203R2024) WAS ATTEMPTED TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16690844 ↗
• MalfunctionMar 27, 2023Unintended Movement; Unintended Movement

  THIS WILL BE FILED TO REPORT A MITRACLIP THAT OPENED WHILE LOCKED. IT WAS REPORTED THAT A PATIENT PRESENTED WITH GRADE 4 PRIMARY MITRAL REGURGITATION (MR). ONE MITRACLIP WAS IMPLANTED SUCCESSFULLY. A SECOND DEVICE, A MITRACLIP XT, OPENED WHILE LOCKED AFTER DEPLOYMENT. BEFORE OPENING, THE CLIP ANGLE WAS 10 DEGREES, AND AFTER DETACHMENT FROM THE CLIP DELIVERY SYSTEM (CDS), THE XT OPENED TO 20-25 DEGREES. THE CLIP WAS STABLE AND THE PROCEDURE WAS COMPLETED WITH AN MR GRADE OF 1. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16621791 ↗
• MalfunctionMar 23, 2023Difficult to Open or Close; Difficult to Open or Close

  THIS WILL BE FILED TO REPORT A SINGLE GRIPPER ACTUATION ISSUE. IT WAS REPORTED THAT A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT FUNCTIONAL MITRAL REGURGITATION GRADE 4+. TWO CLIPS WERE IMPLANTED SUCCESSFULLY. A THIRD CLIP WAS INSERTED, BUT UPON GRASPING, IT WAS OBSERVED THE POSTERIOR GRIPPER WOULD NOT RAISE. THE PHYSICIAN STATE THE ANTERIOR LEAFLET HAD A GOOD GRASP, SO THE CLIP WAS DEPLOYED. IT WAS NOTED THE CLIP WAS STABLE ON BOTH LEAFLETS. AN ADDITIONAL CLIP WAS IMPLANTED, REDUCING MR TO A GRADE OF 4. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT SEQUELAE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16603035 ↗
• InjuryMar 13, 2023Unintended Movement; Unintended Movement

  THIS IS FILED TO REPORT FAILED ESTABLISHING FINAL ARM ANGLE. IT WAS REPORTED THAT A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH GRADE 4, MYXOMATOUS, BARLOW VALVE, THICKENED LEAFLETS, DILATED ANNULUS, LARGE PROLAPSE/FLAIL, AND A SMALL AND NARROW ATRIUM. ONE CLIP SUCCESSFULLY IMPLANTED WITHOUT ISSUE. TO FURTHER REDUCE MR, AN XT CLIP WAS INSERTED AND PLACED ON THE MITRAL VALVE. HOWEVER, WHILE ESTABLISHING FINAL ARM ANGLE (EFAA), IT WAS OBSERVED THAT THE CLIP WAS OPENED TO APPROXIMATELY 40 DEGREES. THE PHYSICIAN DECIDED TO DEPLOY THE CLIP. AN ADDITIONAL CLIP WAS IMPLANTED TO STABILIZE THE OPENED CLIP AND TREAT MR LATERALLY. MR WAS REDUCED TO A GRADE OF 1. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16534258 ↗
• MalfunctionFeb 20, 2023Unintended Movement; Unintended Movement

  THIS IS FILED TO REPORT THE XT MITRACLIP OPENING DURING ESTABLISHMENT OF FINAL ARM ANGLE. IT WAS REPORTED THAT A MITRACLIP PROCEDURE WAS PERFORMED ON (B)(6) 2022, TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) GRADE 3-4. AN XTW CLIP (20817R1042) WAS SUCCESSFULLY IMPLANTED. IMAGING WAS DIFFICULT. APPROXIMATELY 20 MINUTES WAS SPENT TRYING TO CONFIRM CAPTURE OF THE LEAFLET WITH THE POSTERIOR GRIPPER. THE CLIP WAS PLACED, REDUCING MR TO TRACE. AFTER REVIEWING THE 3D IMAGE POST DEPLOYMENT, IT APPEARED THAT THE CLIP MAY HAVE BEEN PARTIALLY GRASPING LEAFLET AND PART OF THE CLEFT. HOWEVER, THE CLIP WAS STABLE AND NO ADDITIONAL CLIPS WERE IMPLANTED. ON (B)(6) 2023, THE PATIENT RETURNED WITH A MR GRADE OF 4 AND THE ORIGINALLY IMPLANTED CLIP WAS DETACHED FROM THE POSTERIOR LEAFLET (SINGLE LEAFLET DEVICE ATTACHMENT (SLDA)). TISSUE DAMAGE COULD NOT BE RULED OUT. THE SLDA WAS ATTEMPTED TO BE STABILIZED WITH AN XT MITRACLIP (20614R129). THERE WERE SLIGHT IMAGING ISSUES. THE XT CLIP WAS POSITIONED MEDIALLY TO THE SLDA. HOWEVER, THE CLIP OPENED DURING THE SECOND ESTABLISHMENT OF FINAL ARM ANGLE (EFAA). THE CLIP WAS ABLE TO BE RE-OPENED, INVERTED, AND REMOVED FROM THE BODY. A REPLACEMENT XT CLIP WAS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16406307 ↗
• DeathFeb 20, 2023Entrapment of Device; Device Damaged by Another Device; Entrapment of Device; Device Damaged by Another Device

  THIS IS BEING FILED TO REPORT A PATIENT DEATH POST-MITRACLIP PROCEDURE. THE PATIENT PASSED AWAY ON (B)(6) 2023, DUE TO RIGHT VENTRICULAR FAILURE ASSOCIATED TO THE PATIENT'S POOR HEALTH. THE PATIENT WAS AWAITING A LUNG TRANSPLANT. IT IS CURRENTLY UNKNOWN WHETHER THE MITRACLIP CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 16405907 ↗
• MalfunctionFeb 17, 2023Improper or Incorrect Procedure or Method; Unintended Movement; Improper or Incorrect Procedure or Method; Unintended Movement

  THIS IS FILED TO REPORT THAT THE CLIP OPENED WHILE ESTABLISHING FINAL ARM ANGLE. IT WAS REPORTED THAT A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT FUNCTIONAL MITRAL REGURGITATION WITH GRADE 4+. A MITRACLIP WAS IMPLANTED WITHOUT ISSUE. FOLLOWING THE IMPLANT OF THE FIRST CLIP, A MITRACLIP XT, WAS USED, BUT IT WAS NOTICED THAT THE CLIP SETTLED. IT OPENED/SETTLED SLIGHTLY DURING ESTABLISHING FINAL ARM ANGLE (EFAA). DURING ESTABLISHMENT OF FINAL ARM ANGLE (EFAA), THE CLIP WAS OBSERVED TO CONTINUOUSLY OPEN FROM 5 DEGREES TO 30 DEGREES. THE CLIP WAS RE-CLOSED, AND THEN OPENED AGAIN. THE PHYSICIAN PROCEEDED WITH DEPLOYMENT AND THE MITRACLIP WAS IMPLANTED. IT WAS NOTED THAT FOLLOWING DEPLOYMENT, THE CLIP DID NOT OPEN ANYMORE THAN IT HAD DURING EFAA. THE PROCEDURE WAS COMPLETED WITH A FINAL MR GRADE OF 1+. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16397671 ↗