MITRACLIP CDS0601-NTRRecalls & reported problems

Summary

The FDA's MAUDE database contains 641 adverse event reports that list this exact device (DI 08717648226342), received between Dec 10, 2018 and May 12, 2026 — classified as 21 deaths, 352 injuries, 268 malfunctions.

The most frequently reported specific device problem is “Incomplete Coaptation” (186 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-0116-2023 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 641 reports, in the reporter's own words as published by the FDA.

• InjuryMay 12, 2026Difficult to Remove

  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 NTR WAS SUCCESSFULLY PLACED ON THE LEAFLETS WHEN THE MEAN PRESSURE GRADIENT (MPG) WAS MEASURED TO BE 10 MMHG. THE CLIP WAS REMOVED, AND THE PROCEDURE WAS DISCONTINUED WHEN THE MPG RETURNED TO BASELINE. THE FINAL MR REMAINED AT GRADE 3+. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED. IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT HAD A FOLLOW-UP EXAMINATION WHEN IT WAS IDENTIFIED THAT THE MR INCREASED TO GRADE 4+. A POSTOPERATIVE ULTRASOUND IDENTIFIED TISSUE DAMAGE TO THE VALVE LEAFLETS. THE PATIENT REMAINED IN THE HOSPITAL FOR CONTINUED MEDICATION TREATMENT.

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

  MAUDE report 25152733 ↗
• InjuryDec 12, 2025Incomplete Coaptation; Unintended Movement; Incomplete Coaptation; Unintended Movement

  IT WAS REPORTED THAT A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 4+, PROLAPSED ANTERIOR LEAFLET, SHORT POSTERIOR LEAFLET, LARGE GAP BETWEEN ANTERIOR AND POSTERIOR LEAFLETS, DILATED LEFT ATRIUM, DILATED LEFT VENTRICLE, AND 6-7MM POSTERIOR LEAFLET. A STEERABLE GUIDE CATHETER (SGC) AND A MITRACLIP NTR CLIP DELIVERY SYSTEM (CDS) WERE INSERTED AND SUCCESSFULLY DELIVERED TO THE LEFT ATRIUM. HOWEVER, AFTER THE CDS WAS DELIVERED TO THE LEFT VENTRICLE, IMAGING REVEALED THAT THE CDS SWAYED SIGNIFICANTLY ALONG WITH THE SGC WITH THE HEARTBEAT. IT WAS NOTED THAT THE SGC TOUCHED THE VENTRICULAR MUSCLE. THE CLIP WAS DEPLOYED ON THE MITRAL VALVE. HOWEVER, POST DEPLOYMENT, THE CLIP DETACHED FROM THE ANTERIOR LEAFLET AND REMAINED ATTACHED TO THE POSTERIOR LEAFLET (SINGLE LEAFLET DEVICE ATTACHMENT/SLDA). NO ADDITIONAL CLIPS WERE IMPLANTED, AND THE MR REMAINED AT A GRADE OF 4+. DUE TO THE SIGNIFICANT SWING OF THE CLIP, THE PATIENT WAS TRANSFERRED TO SURGERY FOR THORACOTOMY AND MITRAL VALVE REPAIR SURGERY. THE PATIENT WAS REPORTED TO BE STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23794959 ↗
• MalfunctionDec 10, 2025Device Damaged by Another Device; 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 23767025 ↗
• InjuryJul 28, 2025Difficult or Delayed Positioning; Incomplete Coaptation; Difficult or Delayed Positioning; Incomplete Coaptation

  IT WAS REPORTED ON (B)(6) 2025 A PATIENT PRESENTED WITH GRADE 4+ MITRAL REGURGITATION (MR) AND A RESTRICTED POSTERIOR LEAFLET FOR A MITRACLIP PROCEDURE. THE PATIENT HAD AN EJECTION FRACTION VALUE OF 37, ACCOMPANIED BY VENTRICULAR TACHYCARDIA. THE PATIENT'S LEFT VENTRICULAR END-SYSTOLIC DIAMETER WAS 60MM, HAD POSTERIOR LEAFLET TETHERING OF THE MITRAL VALVE, AND PSEUDO-DEPRESSION OF THE ANTERIOR LEAFLET OF THE MITRAL VALVE. THE POSTERIOR 2 LEAFLET SEGMENT WAS 8MM IN LENGTH AND THE ANTERIOR 2 LEAFLET SEGMENT WAS 20MM IN LENGTH. A MITRACLIP NTW WAS SELECTED FOR IMPLANT. DURING THE PROCEDURE, DUE TO THE TETHERING OF THE POSTERIOR LEAFLET, GRASPING THE LEAFLETS WAS DIFFICULT. FOUR ATTEMPTS WERE MADE TO GRASP THE LEAFLETS. THE POSTERIOR LEAFLET WAS GRASPED AT 7MM AND THE ANTERIOR LEAFLET WAS GRASPED AT 8MM. THE CLIP WAS CLOSED AND IT WAS NOTED THAT THE MR GRADE DECREASED TO 2+. HOWEVER, A PARTIAL TEARING OF THE POSTERIOR LEAFLET WAS OBSERVED. THE DECISION WAS MADE TO FULLY DEPLOY THE CLIP. THE FOLLOWING DAY ON (B)(6) 2025 A SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) WAS OBSERVED. THE POSTERIOR LEAFLET PROLAPSED, AND THE CLIP REMAINED ATTACHED TO THE ANTERIOR LEAFLET. THE MR GRADE INCREASED T

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

  MAUDE report 22631676 ↗
• InjuryJul 23, 2025Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2025, A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) GRADE 4+. A MITRACLIP NTR WAS CHOSEN FOR IMPLANTATION. AFTER IMPLANT, THE CLIP DETACHED FROM THE POSTERIOR LEAFLET (SINGLE LEAFLET DEVICE ATTACHMENT (SLDA)). TISSUE DAMAGE WAS OBSERVED. NO FURTHER INTERVENTION WAS PERFORMED AND THE PROCEDURE WAS ABORTED WITH MR UNCHANGED. WHEN THE STEERABLE GUIDE CATHETER (SGC) WAS REMOVED AND AN ATRIAL SEPTAL DEFECT WAS OBSERVED. NO INTERVENTION WAS PERFORMED FOR THE ATRIAL SEPTAL DEFECT AND THE PATIENT WAS REPORTED TO BE STABLE.

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

  MAUDE report 22576144 ↗
• InjuryMay 8, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THIS WAS A MITRACLIP PROCEDURE TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 4+. DURING THE PROCEDURE, IT WAS NOTED THAT THE KNOB OF THE STEERABLE GUIDE CATHETER (SGC) WAS NOT USEFUL AND CAUSED DIFFICULTY IN MOVING THE DEVICE. IN RESULT, THE CLIP WAS UNABLE TO GRASP AND CAPTURE THE LEAFLETS WELL. IT WAS ALSO NOTED THAT A CHORDAL RUPTURE HAD OCCURRED. NO CLIP WAS IMPLANTED AND THE PATIENT WAS CONVERTED TO SURGERY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 21988184 ↗
• InjuryMar 17, 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. AFTER THE TRANSSEPTAL PUNCTURE WAS PERFORMED, IT WAS NOTICED THAT THE ATRIAL SEPTUM WAS DAMAGED DUE TO THE LARGE SHEATH PASSING THROUGH IT. VENTRICULAR FIBRILLATION AND TAMPONADE WERE NOTED AFTER THE PERFORATION AND PERICARDIOCENTESIS WAS PERFORMED. ONE CLIP WAS PREPARED AND ADVANCED, HOWEVER, IN THE PROCESS OF ATTEMPTING TO GRASP AND CAPTURE THE LEAFLETS, A LEAFLET TEAR WAS OBSERVED. MR INCREASED TO 4+. THE CLIP WAS REMOVED AND THE PROCEDURE WAS ABANDONED. MITRAL VALVE REPLACEMENT SURGERY WAS PERFORMED AFTER REMOVAL OF THE CLIP.

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

  MAUDE report 21619863 ↗
• InjuryOct 4, 2024Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THIS WAS A MITRACLIP PROCEDURE TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE 4+. THE MEAN PRESSURE GRADIENT (MPG) WAS 1MMHG. IT WAS NOTED IMAGING WAS CHALLENGING DUE TO AN ENLARGED ATRIUM, POSTERIOR FLAIL, AND LONG POSTERIOR LEAFLET. DURING THE PROCEDURE, THE PHYSICIAN STATED THERE WAS A DELAY IN STEERABLE GUIDE CATHETER (SGC) WHEN POSITIONING THE DEVICE. THE PROCEDURE WAS CONTINUED WITHOUT REPLACING THE SGC. AN XTR CLIP (31221R1003) WAS INSERTED AND ADVANCED INTO THE LEFT VENTRICLE (LV). HOWEVER, WHILE IN THE LV, THE CLIP BECAME CAUGHT IN CHORDAE. TROUBLESHOOTING WAS PERFORMED, BUT THE CLIP WAS UNABLE TO BE REMOVED FROM CHORDAE. ALTHOUGH STILL ATTACHED, THE CLIP WAS ABLE TO BE DEPLOYED ON BOTH LEAFLETS. MR DECREASED TO A GRADE OF 3+ AND THE MPG INCREASED TO 5MMHG. AN NTR CLIP (31122R1048) WAS THEN INSERTED AND DEPLOYED WITHOUT ISSUES, REDUCING MR TO A GRADE OF 1+. IT WAS NOTED THE MPG INCREASED TO 6MMHG, BUT THE PHYSICIAN WAS SATISFIED WITH THE RESULTS OF THE PROCEDURE. THE FOLLOWING DAY, ECHOCARDIOGRAPHY WAS PERFORMED AND SHOWED THE NTR CLIP HAD DETACHED FROM THE ANTERIOR LEAFLET AND REMAINED ATTACHED TO THE POSTERIOR LEAFLET (SINGLE LEAFLET DEVICE

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 20373904 ↗
• InjuryJul 15, 2024Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THIS WAS A MITRACLIP PROCEDURE TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) WITH A GRADE OF 4+ AND A PROLAPSED ANTERIOR. IT WAS NOTED THAT IMAGING WAS DIFFICULT AND THERE WERE DIFFICULTIES POSITIONING THE STEERABLE GUIDE CATHETER (SGC). ONE CLIP WAS SUCCESSFULLY IMPLANTED. TO FURTHER REDUCE MR, AN NTR CLIP WAS INSERTED AND DEPLOYED ON THE MITRAL VALVE. HOWEVER, AFTER DEPLOYMENT, THE CLIP DETACHED FROM THE POSTERIOR LEAFLET AND REMAINED ATTACHED TO THE ANTERIOR LEAFLET (SINGLE LEAFLET DEVICE ATTACHMENT/SLDA). TO STABILIZE THE SLDA, AN ADDITIONAL CLIP WAS IMPLANTED, REDUCING MR TO A GRADE OF 3-4. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19740749 ↗
• InjuryJul 11, 2024Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THAT A PATIENT PRESENTED WITH GRADE 4 FUNCTIONAL MITRAL REGURGITATION (MR) AND A PROLAPSED POSTERIOR LEAFLET FOR A MITRACLIP PROCEDURE. IT WAS NOTED THAT DURING DEVICE PREP OF THE STEERABLE GUIDE CATHETER (SGC), THE TIP REMAINED CURVED DURING ATTEMPTS TO STRAIGHTEN. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS STARTED. AFTER THE FIRST CLIP WAS IMPLANTED, A SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) WAS OBSERVED. THE POSTERIOR LEAFLET WAS DETACHED. A SECOND CLIP WAS IMPLANTED TO STABILIZE THE SLDA. THE MR WAS REDUCED TO GRADE 1-2. THERE WAS NO CLINICALLY SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19723810 ↗
• InjuryJul 9, 2024Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED ON MAY 22, 2024, A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 4+ AND AN ANTERIOR PROLAPSE. TWO CLIPS WERE IMPLANTED, REDUCING MR TO A GRADE OF 3. ON (B)(6) 2024, ECHOCARDIOGRAPHY SHOWED MR HAD INCREASED TO A GRADE OF 4+. ON (B)(6) 2024, IT WAS DISCOVERED THAT BOTH IMPLANTED CLIPS HAD DETACHED FROM THE POSTERIOR LEAFLET AND REMAINED ATTACHED TO THE ANTERIOR LEAFLET (SINGLE LEAFLET DEVICE ATTACHMENT/SLDA). A SECOND MITRACLIP PROCEDURE WAS PERFORMED TO STABILIZE THE SLDA'S. HOWEVER, THE CLIP WAS UNABLE TO BE IMPLANTED; THEREFORE, THE PROCEDURE WAS DISCONTINUED. IT WAS NOTED AN ATRIAL SEPTAL DEFECT (ASD) WAS OBSERVED AND WAS CAUSED BY THE STEERABLE GUIDE CATHETER (SGC) FROM THE INITIAL PROCEDURE. NO TREATMENT WAS PERFORMED TO TREAT THE ASD. ON (B)(6) 2024, MITRAL VALVE REPLACEMENT WAS PERFORMED.

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

  MAUDE report 19705400 ↗
• InjuryJun 26, 2024Difficult or Delayed Positioning; Difficult or Delayed Positioning

  IT WAS REPORTED THAT ON (B)(6) 2024, A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT MIXED MITRAL REGURGITATION (MR) GRADE 4+. A NTR (LOT: 31122R1074) WAS CHOSEN FOR IMPLANTATION UTILIZING STEERABLE GUIDE CATHETER (SGC)(LOT: 31207R1052). THE PATIENT PRESENTED WITH POSTERIOR LEAFLET P3 PROLAPSE AND PRE-EXISTING CHORDAL RUPTURE. THE NTR WAS ATTEMPTED TO BE PLACED A3/P3, BUT DUE TO THE POSTERIOR LEAFLET MOTION, GRASPING WAS DIFFICULT. AFTER MULTIPLE ATTEMPTS THE NTR WAS ABLE TO GRASP AND WAS IMPLANTED. AFTER IMPLANTATION A PERFORATION OF THE POSTERIOR LEAFLET WAS OBSERVED. MR INCREASED TO GRADE 4+. A SECOND XTR CLIP (LOT: 40102R1026) WAS ATTEMPTED BUT WAS NOT IMPLANTED WITHOUT DEVICE ISSUE. THE PATIENT WAS SENT TO CARDIAC SURGERY. THE PHYSICIAN THOUGH THE SGC COULD NOT GIVE ENOUGH SUPPORTING STRENGTH AND HAD SOME PROBLEMS.

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

  MAUDE report 19617856 ↗
• InjuryJun 24, 2024Break; Difficult to Remove; Difficult to Open or Close; Noise, Audible; Break; Difficult to Remove; Difficult to Open or Close; Noise, Audible

  IT WAS REPORTED THAT A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) WITH A GRADE OF 4+, RESTRICTED POSTERIOR LEAFLET, DILATED LEFT ATRIUM (LA), AND DILATED LEFT VENTRICLE (LV). A STEERABLE GUIDE CATHETER (SGC) AND A MITRACLIP XTR WERE INSERTED, AND THE CLIP WAS IMPLANTED WITHOUT ISSUES. TO FURTHER REDUCE THE MR, A MITRACLIP NTR WAS INSERTED WITHOUT ISSUES. HOWEVER, WHILE APPLYING THE PLUS AND MINUS KNOBS OOF THE SGC, IT WAS NOTED THAT IT WAS TOO FLEXIBLE, AND COULD NO LONGER STRAIGHTEN THE SGC. WHILE THE NTR WAS IN THE VALVE, IT WAS OBSERVED THAT ONE GRIPPER WAS NOT FUNCTIONING AS INTENDED. THE CLIP HAD BECOME CAUGHT IN CHORDAE. TROUBLESHOOTING WAS PERFORMED, AND THE CLIP WAS ABLE TO BE REMOVED FROM THE CHORDAE. HOWEVER, IT WAS OBSERVED THAT A CHORDAL RUPTURE OCCURRED., THE CLIP WAS REMOVED FROM THE PATIENT. WHILE OUTSIDE THE PATIENT, IT WAS OBSERVED THAT THE GRIPPER LINE WAS BROKEN. ANOTHER CLIP WAS INSERTED AND IMPLANTED WITHOUT ISSUES, REDUCING THE MR TO A GRADE OF 2-3. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 19594922 ↗
• InjuryJun 20, 2024Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2020, A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) WITH A GRADE OF 4. ONE CLIP WAS IMPLANTED, REDUCING MR TO A GRADE OF <1. ON (B)(6) 2024, ECHOCARDIOGRAM SHOWED THE IMPLANTED CLIP HAD DETACHED FROM POSTERIOR LEAFLET AND REMAINED ATTACHED TO ANTERIOR LEAFLET (SINGLE LEAFLET DEVICE ATTACHMENT/SLDA), CAUSING MR TO INCREASE TO A GRADE OF 3-4.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 19575047 ↗
• InjuryFeb 26, 2024Positioning Failure; Adverse Event Without Identified Device or Use Problem; Positioning Failure; Adverse Event Without Identified Device or Use Problem

  SUBSEQUENT TO THE INITIALLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED STATING THE CLIP WAS UNABLE TO CAPTURE THE LEAFLETS. AFTER THE SGC WAS REMOVED, DEFORMATION TO THE SOFT TIP OF THE SGC WAS ALSO OBSERVED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 18777742 ↗
• MalfunctionJan 17, 2024Positioning Failure; Unintended Movement; Positioning Failure; Unintended Movement

  IT WAS REPORTED THAT A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 4+, AND A PROLAPSED POSTERIOR MITRAL LEAFLET. A MITRACLIP NTR WAS INSERTED AND GRASPING WAS PERFORMED. HOWEVER, THE M KNOB DID NOT WORK AS USUAL. EACH TIME THE M KNOB WAS APPLIED TO REACH THE JUNCTION AREA, IT WOULD REBOUND SLIGHTLY, AND THE LEAFLETS WERE UNABLE TO BE GRASPED OR CAPTURED. THEREFORE, THE CLIP WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS DISCONTINUED. NO 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18528411 ↗
• MalfunctionSep 7, 2023Positioning Failure; Unintended Movement; Positioning Failure; Unintended Movement

  THIS IS FILED TO REPORT UNINTENDED MOVEMENT. IT WAS REPORTED THAT A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) WITH GRADE 4+ AND AN ENLARGED ATRIUM. A MITRACLIP NTR WAS USED, BUT CURVATURE COULD NOT BE MAINTAINED WHILE APPLYING THE M-KNOB, AND THE CLIP HAD A REBOUND PHENOMENON. THE CLIP WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH NO CLIPS IMPLANTED. THE MR REMAINED AT GRADE 4+. 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 17705484 ↗
• DeathAug 20, 2023Migration; Migration

  THIS IS FILED TO A PATIENT DEATH. IT WAS REPORTED THAT ON (B)(6) 2023, A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) WITH GRADE 4+ AND ENLARGED ATRIUM. WHILE PREPARING A MITRACLIP NTR (20830R167) UNINTENDED MOVEMENT WHILE ESTABLISHING FINAL ARM ANGLE (EFAA) OF THE CLIP OCCURRED; THE CLIP OPENED APPROXIMATELY 10 DEGREES DURING FIRST ESTABLISHING FINAL ARM ANGLE (EFAA). THE SECOND TIME ESTABLISHING FINAL ARM ANGLE WORKED. THE MITRACLIP DEVICE WAS IMPLANTED AT A2/P2 AND THE MITRAL REGURGITATION DECREASED TO GRADE 2+. THE FINAL ARM ANGLE OF THE FIRST CLIP WAS APPROXIMATELY 20 DEGREES. ANOTHER MITRACLIP NTR (21228R1026) WAS IMPLANTED 2MM FROM THE FIRST CLIP AND THE MITRAL REGURGITATION DECREASED TO GRADE 1+. THE PROCEDURE WAS COMPLETED WITH TWO CLIPS IMPLANTED, REDUCING MITRAL REGURGITATION TO GRADE 1+. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. FOLLOWING THE PROCEDURE, DURING PATIENT MONITORING, THE MITRAL REGURGITATION HAD INCREASED TO GRADE 4+, THE PATIENT HAD NO IMPROVEMENT, WITH SYMPTOMS OF FATIGUE, DYSPNEA, LIMB EDEMA, AND SHORTAGE OF LIBERTIES. ON (B)(6) 2023, THE PATIENT DIED DUE TO AGGRAVATED HEART FAILURE. ECHO IMAGING REVEA

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

  MAUDE report 17581279 ↗
• InjuryJul 28, 2023Incomplete Coaptation; Incomplete Coaptation

  THIS WILL BE FILED TO REPORT INCOMPLETE COAPTATION. IT WAS REPORTED THAT ON (B)(6) 2023 A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) GRADE 4 WITH ENLARGED ATRIA, A PROLAPSED POSTERIOR, AND THIN LEAFLETS. IT WAS NOTED THAT STEERABLE GUIDE CATHETER (SGC) WAS DIFFICULT TO BEND DURING THE PROCEDURE. ALTHOUGH DIFFICULT, TWO CLIPS WERE SUCCESSFULLY IMPLANTED, REDUCING MR TO A GRADE OF <1. ON (B)(6) 2023 A TRANSTHORACIC ECHOCARDIOGRAM WAS PERFORMED AND IT WAS OBSERVED THAT BOTH CLIPS DETACHED FROM THE POSTERIOR LEAFLET AND REMAINED ATTACHED TO THE ANTERIOR LEAFLET (SINGLE LEAFLET DEVICE ATTACHMENT/SLDA), CAUSING THE MR TO INCREASE TO A GRADE OF 3-4. THE PATIENT WAS THEN TRANSFERRED TO SURGERY WHERE THE CLIPS WERE EXPLANTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 17420125 ↗
• InjuryJul 28, 2023Incomplete Coaptation; Incomplete Coaptation

  THIS WILL BE FILED TO REPORT A SINGLE LEAFLET DEVICE ATTACHMENT (SLDA). IT WAS REPORTED THAT A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) GRADE 4+ WITH AN ENLARGED LEFT ATRIUM. SHORTLY AFTER DEPLOYMENT OF THE FIRST CLIP, THE FIRST CLIP DETACHED FROM THE POSTERIOR LEAFLET AND REMAINED ATTACHED TO THE ANTERIOR LEAFLET (SINGLE LEAFLET DEVICE ATTACHMENT/SLDA). IN THE TREATING PHYSICIAN'S OPINION, THE SLDA WAS DUE TO THE PATIENT'S ANATOMY AND INSUFFICIENT LEAFLET GRASPING. IT WAS ALSO NOTED THE STEERABLE GUIDE CATHETER WAS DIFFICULT TO CURVE. THE PROCEDURE WAS THEN CONCLUDED WITH 1 CLIP IMPLANTED AND NO CHANGE IN MR. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 17413602 ↗
• InjuryJul 21, 2023Incomplete Coaptation; Unintended Movement; Incomplete Coaptation; Unintended Movement

  THIS IS FILED TO REPORT UNINTENDED MOVEMENT OF THE DELIVERY CATHETER (DC) HANDLE, AND A SINGLE LEAFLET DEVICE ATTACHMENT (SLDA), REQUIRING INTERVENTION. IT WAS REPORTED THAT A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT MIXED MITRAL REGURGITATION (MR) GRADE 3+ WITH AN ENLARGED ATRIUM AND A PROLAPSED ANTERIOR LEAFLET. THE FIRST CLIP (NTR) WAS ADVANCED TO THE MITRAL VALVE. IT WAS NOTED THAT THE DELIVERY CATHETER (DC) HANDLE COULD ROTATE WHILE THE DC FASTENER WAS FASTENED. THE CLIP WAS ABLE TO BE IMPLANTED. FEW MINUTES AFTER DEPLOYMENT, THE CLIP HAD DETACHED FROM THE ANTERIOR LEAFLET (SINGLE LEAFLET DEVICE ATTACHMENT (SLDA)). ANOTHER CLIP (XTR) WAS ADVANCED TO THE MITRAL VALVE. DUE TO SLDA, THE LEAFLETS WERE NOT MOVING SYNCHRONOUSLY, CAUSING DIFFICULTY GRASPING THE LEAFLETS. A LOSS OF LEAFLET CAPTURE WAS EXPERIENCED AFTER THE GRIPPERS WERE LOWERED. AFTER ABOUT SIX HOURS OF GRASPING ATTEMPTS, THE PHYSICIAN CONCLUDED THAT THE SYSTEM WAS UNSTABLE. IT WAS NOTED THAT THE M-KNOB DID NOT WORK AS USUAL; AND THE DELIVERY CATHETER (DC) HANDLE COULD ROTATE WHILE THE DC FASTENER WAS FASTENED. THE SECOND CLIP WAS REMOVED. IT WAS NOTED THAT THE ¿+¿ KNOB ON THE STEERABLE GUIDE CATHETER (SGC) HAD TO B

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17371982 ↗
• DeathMay 16, 2023Unintended Movement; Migration; Unintended Movement; Migration

  SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED. ON (B)(6), 2023, A MITRACLIP PROCEDURE WAS PERFORMED. DURING STEERABLE GUIDE CATHETER (SGC) INSERTION, A LOOSE CONNECTION BETWEEN THE STABILIZER AND THE STEERABLE GUIDE CATHETER (SGC) OCCURRED. THE PLASTIC SGC HANDLE WAS ROTATING INDEPENDENTLY. WHEN ROTATING THE PLASTIC HANDLE, THE SGC SHAFT ROTATED AS WELL, BUT AT A DIFFERENT SPEED, AND NOT SYNCHRONIZED. THE STABILIZER WAS EXCHANGED FOR ANOTHER TO CONTINUE WITH THE PROCEDURE. TO ENSURE STABILITY, THE PHYSICIAN HELD THE PLASTIC HANDLE TO THE SGC THROUGHOUT THE PROCEDURE. A MITRACLIP WAS IMPLANTED ON A2/P2 AND THE MR DECREASED TO GRADE 2+. THE FINAL ANGLE OF THE FIRST CLIP WAS APPROXIMATELY 20 DEGREES. A SECOND CLIP WAS PREPARED AND WHILE ESTABLISHING FINAL ARM ANGLE (EFAA) THE FIRST TIME, THE CLIP OPENED TO ABOUT TEN DEGREES. THE SECOND TIME THE EFAA WORKED. THE CLIP WAS IMPLANTED 2MM FROM THE FIRST CLIP AND THE MR DECREASED TO GRADE 1+. THE FINAL ANGLE OF THE SECOND CLIP WAS APPROXIMATELY 20 DEGREES. THE PROCEDURE WAS COMPLETED WITH TWO CLIPS IMPLANTED WITHOUT ISSUE. THE MR WAS REDUCED TO GRADE 1+. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCE

  Patient problems: Dyspnea; Fatigue; Heart Failure/Congestive Heart Failure; Mitral Valve Insufficiency/ Regurgitation; Swelling/ Edema

  MAUDE report 16941245 ↗
• InjuryApr 18, 2023Incomplete Coaptation; Incomplete Coaptation

  THIS WILL BE FILED TO REPORT A SINGLE LEAFLET DEVICE ATTACHMENT AND RECURRENT MITRAL REGURGITATION IT WAS REPORTED THAT ON (B)(6) 2023 A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT MIXED MITRAL REGURGITATION (MR) GRADE 4+ WITH A PROLAPSED ANTERIOR LEAFLET. TWO CLIPS WERE SUCCESSFULLY IMPLANTED, AND THE PROCEDURE WAS CONCLUDED WITH A RESULTING MR OF GRADE 1+. ON (B)(6) 2023 A TRANSTHORACIC ECHOCARDIOGRAM (TTE) WAS PERFORMED AND SHOWED ONE OF THE IMPLANTED CLIPS 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. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 16763765 ↗
• InjuryMar 24, 2023Incomplete Coaptation; Incomplete Coaptation

  SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED: ON (B)(6) 2023, THE PATIENT PRESENTED TO THE HOSPITAL WITH SHORTNESS OF BREATH AND FATIGUE.

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

  MAUDE report 16611874 ↗
• InjuryJan 6, 2023Migration; Migration

  THIS IS FILED TO REPORT CLIP MIGRATION REQUIRING INTERVENTION. IT WAS REPORTED THAT ON (B)(6) 2019 A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT FUNCTIONAL MITRAL REGURGITATION GRADE 4.TWO CLIPS WERE SUCCESSFULLY IMPLANTED WITH AN MR REDUCTION OF GRADE 2. ON (B)(6) 2022 A SECONDARY MITRACLIP PROCEDURE WAS PERFORMED DUE TO ONE OF THE PREVIOUSLY IMPLANTED CLIPS PARTIALLY DETACHING FROM THE ANTERIOR LEAFLET. IN THE PHYSICIANS' OPINION, THE CLIP PARTIALLY CAME OFF OF THE ANTERIOR LEAFLET DUE TO THE PATIENTS THIN, FRAIL LEAFLETS. AN ADDITIONAL CLIP WAS IMPLANTED TO STABILIZE THE PARTIALLY DETACHED CLIP. THE PROCEDURE WAS SUCCESSFUL AND THE MR WAS REDUCED FROM GRADE 4 TO 2. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT SEQUELAE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 16113167 ↗