MITRACLIP CDS0701-NTWRecalls & reported problems

Summary

The FDA's MAUDE database contains 959 adverse event reports that list this exact device (DI 08717648230967), received between Dec 4, 2019 and Oct 17, 2025 — classified as 22 deaths, 564 injuries, 373 malfunctions.

The most frequently reported specific device problem is “Incomplete Coaptation” (290 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 959 reports, in the reporter's own words as published by the FDA.

• InjuryOct 17, 2025Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED ON (B)(6) 2025 THAT THE PATIENT PRESENTED WITH GRADE 4 DEGENERATIVE MITRAL REGURGITATION (MR) AND PROLAPSED POSTERIOR LEAFLET FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, 2 MITRACLIPS WERE SUCCESSFULLY IMPLANTED. ON AN UNKNOWN DATE THE PATIENT WAS HOSPITALIZED FOR HEART FAILURE. IT WAS DISCOVERED THAT THE SECOND CLIP HAD SINGLE LEAFLET DEVICE ATTACHMENT(SLDA). THE CLIP DETACHED FROM THE POSTERIOR LEAFLET. PER THE PHYSICIAN, SLDA WAS DUE TO CONNECTIVE TISSUE DISEASE. RECURRENT MR OF GRADE 4 WAS REPORTED. ON (B)(6) 2025 AN ADDITIONAL CLIP WAS IMPLANTED LATERAL TO THE SLDA. THERE WAS NO CLINICALLY SIGNIFICANT DELAY.

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

  MAUDE report 23328643 ↗
• InjuryOct 15, 2025Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THAT A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) WITH A GRADE OF 4, THIN, AND DISEASED LEAFLETS. A MITRACLIP NTW WAS INSERTED AND DEPLOYED ON THE MITRAL VALVE, REDUCED TO MR GRADE OF 1-2. ON (B)(6) 2025, THE PATIENT RETURNED WITH SHORTNESS OF BREATH. AN ECHOCARDIOGRAM WAS PERFORMED AND REVEALED THAT THE CLIP HAD DETACHED FROM THE ANTERIOR LEAFLET AND REMAINED ON THE POSTERIOR LEAFLET (SINGLE LEAFLET DEVICE ATTACHMENT/SLDA), AND A TORN ANTERIOR LEAFLET, CAUSING MR TO INCREASE TO A GRADE OF 4. ON (B)(6) 2025, A SECOND MITRACLIP PROCEDURE WAS PERFORMED. TWO CLIPS WERE IMPLANTED.

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

  MAUDE report 23295325 ↗
• InjurySep 4, 2025Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2020, A PATIENT PRESENTED WITH GRADE 4 DEGENERATIVE MITRAL REGURGITATION (MR) AND A POSTERIOR PROLAPSE FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, TWO MITRACLIPS (NTW AND NT) WERE IMPLANTED SUCCESSFULLY. THE FINAL MR WAS GRADE 1. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED. ON AN APPROXIMATE DATE, (B)(6) 2025, THE PATIENT RETURNED SYMPTOMATIC WITH DYSPNEA, A TRANSTHORACIC ECHOCARDIOGRAM (TTE) SHOWED THAT THE MITRACLIP NTW HAD A SINGLE LEAFLET DETACHMENT (SLDA) AND THE CLIP WAS NO LONGER ATTACHED TO THE POSTERIOR LEAFLET. THE MR HAD RETURNED TO GRADE 4. ON (B)(6) 2025, THE PATIENT RETURNED WITH GRADE 4 DEGENERATIVE MITRAL REGURGITATION (MR) AND A POSTERIOR PROLAPSE FOR A SECONDARY MITRACLIP PROCEDURE. DURING THE PROCEDURE, A MITRACLIP WAS SUCCESSFULLY IMPLANTED. THE FINAL MR WAS GRADE 2. THERE WAS NO CLINICALLY SIGNIFICANT DELAYS REPORTED.

  Patient problems: Dyspnea; Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 22968396 ↗
• InjuryApr 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS WAS A MITRACLIP PROCEDURE TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 4. IT WAS NOTED IMAGING WAS CHALLENGING DUE TO SHADOWING. IT WAS NOTED THAT AFTER DEPLOYMENT OF A NTW CLIP, THERE WAS A PERFORATION OF THE POSTERIOR LEAFLET. AN ADDITIONAL CLIP WAS PLACED IN THE AREA OF PERFORATION IN ATTEMPT TO COVER SOME OF THE MR. AT THE END OF THE PROCEDURE THE MR WAS UNCHANGED AT GRADE 4.

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

  MAUDE report 21797996 ↗
• DeathOct 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CRD_1002 - EXPAND G4 PHASE 1 AND PHASE 2 STUDY PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT PRESENTED WITH MIXED MITRAL REGURGITATION (MR). ONE MITRACLIP WAS SUCCESSFULLY IMPLANTED, REDUCING THE MR TO GRADE 1+. THERE WAS NO DEVICE DEFICIENCY. ON (B)(6) 2023, THE PATIENT EXPIRED WHILE AT HOME. THERE WAS NO KNOWN RECURRENT REGURGITATION. REPORTEDLY, ADDITIONAL DETAILS ARE NOT AVAILABLE. THERE WAS NO MALFUNCTION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20569705 ↗
• InjuryMar 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBSEQUENT TO THE PREVIOUS REPORT, THE ADDITIONAL DOWNGRADING INFORMATION WAS RECEIVED: PER PHYSICIAN, THE INCREASE IN MR WAS UNRELATED TO THE DEVICE. THERE WAS NO DEVICE MALFUNCTION.

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

  MAUDE report 18886411 ↗
• InjuryMar 5, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THIS WAS A MITRACLIP TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 4. THE STEERABLE GUIDE CATHETER (SGC) WAS INSERTED WITHOUT ISSUES. HOWEVER, WHEN THE CLIP DELIVERY SYSTEM (CDS) WAS INSERTED INTO THE SGC HEMOSTATIC VALVE, AIR WAS OBSERVED IN THE SGC. THIS OCCURRED MULTIPLE TIMES; THEREFORE, THE SGC AND CDS WERE REMOVED AND REPLACED. IT WAS NOTED THE LEAK WAS MORE THAN LIKELY CAUSED BY THE CDS. ONE CLIP WAS THEN SUCCESSFULLY IMPLANTED, REDUCING MR TO A GRADE OF <1. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18839796 ↗
• InjuryFeb 13, 2024Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THAT ON MAY 16, 2022, A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT MIXED MITRAL REGURGITATION (MR) WITH A GRADE OF 4. A MITRACLIP NTW WAS IMPLANTED WITHOUT ISSUES, REDUCING THE MR TO A GRADE OF 2. ON (B)(6) 2024, AN ECHOCARDIOGRAM WAS PERFORMED AND REVEALED RECURRENT MR WITH A GRADE OF 4, A NEW TINY FLAIL, AND THAT THE CLIP HAD DETACHED FROM THE POSTERIOR LEAFLET AND REMAINED ATTACHED TO THE ANTERIOR LEAFLET (SINGLE LEAFLET DEVICE ATTACHMENT/SLDA). TO STABILIZE THE SLDA CLIP, ANOTHER MITRACLIP WAS IMPLANTED, REDUCING THE MR TO A GRADE OF 1-2.

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

  MAUDE report 18696459 ↗
• InjuryFeb 9, 2024Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED ON (B)(6) 2022, A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) WITH A GRADE OF 4. ONE NTW CLIP WAS IMPLANTED, REDUCING MR TO A GRADE OF 1-2. ROUGHLY ONE YEAR POST PROCEDURE, THE PATIENT RETURNED TO THE HOSPITAL. ECHOCARDIOGRAPHY SHOWED THE IMPLANTED CLIP DETACHED FROM THE POSTERIOR LEAFLET AND REMAINED ATTACHED TO THE ANTERIOR LEAFLET (SINGLE LEAFLET DEVICE ATTACHMENT/SLDA), CAUSING MR TO RETURN TO A GRADE OF 4. IT WAS NOTED A NEW POSTERIOR PROLAPSE WAS OBSERVED. ON (B)(6) 2024, AN ADDITIONAL MITRACLIP PROCEDURE WAS PERFORMED. TO STABILIZE THE SLDA, TWO ADDITIONAL CLIPS WERE IMPLANTED, REDUCING MR TO A GRADE OF 2.

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

  MAUDE report 18679902 ↗
• InjuryJan 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CRD_1002 - EXPAND G4 PHASE 1 AND PHASE 2 STUDY PATIENT ID: (B)(6). IT WAS REPORTED THAT ON 01-JULY-2021, THE PATIENT PRESENTED WITH DEGENERATIVE MITRAL REGURGITATION (MR) WITH ANTERIOR AND POSTERIOR LEAFLET PROLAPSE. TWO MITRACLIPS (CDS0701-NTW, 10205U378 AND CDS0701-NT, 10118U217) WERE IMPLANTED, REDUCING THE MR TO GRADE 1+. THERE WAS NO DEVICE DEFICIENCY. ON (B)(6) 2023, THE PATIENT WAS HOSPITALIZED WITH ACUTE METABOLIC ENCEPHALOPATHY AND A LEFT SIDED FACIAL DROOP. PER IMAGING, AN ISCHEMIC STROKE WAS DIAGNOSED. REPORTEDLY, THE PATIENT¿S ANTICOAGULATION MEDICATIONS WERE RECENTLY HELD FOR A GASTROINTESTINAL EVALUATION. MEDICATIONS WERE PROVIDED AND THE PATIENT WENT TO INPATIENT REHABILITATION. THE STROKE EVENT RESOLVED. ON (B)(6) 2023, MITRAL VALVE STENOSIS WAS DIAGNOSED. NO TREATMENT WAS PROVIDED FOR THE STENOSIS. REPORTEDLY, THE EVENT WAS CHRONIC WITH HEART FAILURE SEQUELA. THERE WAS NO DEVICE MALFUNCTION.

  Patient problems: Heart Failure/Congestive Heart Failure; High Blood Pressure/ Hypertension; Mitral Valve Stenosis; Stroke/CVA

  MAUDE report 18565671 ↗
• InjuryDec 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBSEQUENT TO THE PREVIOUSLY REPORTED FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED: ON (B)(6) 2022, AN ECHOCARDIOGRAM WAS PERFORMED AND REVEALED RECURRENT MR WITH A STABLE GRADE OF 2-3. ON (B)(6) 2023, AN ECHOCARDIOGRAM WAS PERFORMED AND REVEALED RECURRENT MR WITH A GRADE OF 4. ON (B)(6) 2023, AN ECHOCARDIOGRAM WAS PERFORMED AND REVEALED RECURRENT MR WITH A GRADE OF 4. THE PREVIOUSLY IMPLANTED CLIPS WERE NOTED TO BE STABLE ON THE LEAFLETS. ON (B)(6) 2023, THE PATIENT WAS REFERRED FOR SURGERY. ON (B)(6) 2023, DURING A SURGICAL OFFICIAL OFFICE VISIT, AN ECHOCARDIOGRAM REVEALED RECURRENT MR. THE IMPLANTED CLIPS WERE NOTED TO BE STABLE.

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

  MAUDE report 18375396 ↗
• InjurySep 24, 2023Incomplete Coaptation; Incomplete Coaptation

  THIS IS FILED TO REPORT INCOMPLETE COAPTATION AND RECURRENT MITRAL REGURGITATION. IT WAS REPORTED THAT ON (B)(6) 2022, A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) WITH GRADE OF 4. ONE CLIP WAS IMPLANTED WITH NO REPORTED ISSUE, REDUCING MR TO GRADE 2. DURING FOLLOW-UP ON (B)(6) 2023, IT WAS OBSERVED ON ECHOCARDIOGRAM THAT THE CLIP HAD DETACHED FROM THE POSTERIOR LEAFLET (SINGLE LEAFLET DEVICE ATTACHMENT (SLDA)). MR WAS NOTED TO INCREASE. NO INTERVENTION WAS PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 17805258 ↗
• MalfunctionSep 18, 2023Break; Difficult to Open or Close; Break; Difficult to Open or Close

  THIS IS FILED TO REPORT A GRIPPER LEVER BREAK. IT WAS REPORTED THAT DURING DEVICE PREPARATION, ALL STEPS WERE FOLLOWED PER INSTRUCTIONS FOR USE (IFU). AS FUNCTIONS OF THE CLIP WERE BEING TESTED, THE GRIPPER LINE APPEARED TO BREAK WHEN THE OPERATOR WAS INSTRUCTED TO "RAISE THE GRIPPERS". THE SUSPECTED GRIPPER ARM WAS LAYING FLAT ON THE CLIP ARM WHEN THE GRIPPER LEVER WAS IN THE RAISED POSITION. AFTER FURTHER EXAMINATION, IT WAS CONFIRMED THE GRIPPER LEVER HAD SNAPPED. A REPLACEMENT COMPLETED THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17765087 ↗
• InjurySep 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING FILED DUE TO RECURRENT MITRAL REGURGITATION DEEMED DEVICE RELATED. CRD_1002 - EXPAND G4 PHASE 1 AND PHASE 2 STUDY. PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT PRESENTED WITH FUNCTIONAL MITRAL REGURGITATION (MR) WITH HYPERTROPHIC CARDIOMYOPATHY AND LEAFLET TETHERING. TWO MITRACLIPS WERE IMPLANTED, REDUCING THE MR TO GRADE 1+. THERE WAS NO DEVICE DEFICIENCY. ON (B)(6) 2023, RECURRENT MR WAS NOTED THE MOST RECENT ECHOCARDIOGRAM SHOWED MR GRADE 1-2+. THE EVENT REQUIRED HOSPITALIZATION, HOWEVER, THERE WAS NO TREATMENT PROVIDED. THERE WAS NO DEVICE DEFICIENCY. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 17758862 ↗
• InjuryAug 24, 2023Incomplete Coaptation; Incomplete Coaptation

  SUBSEQUENT TO THE INITIALLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED STATING ON (B)(6) 2023 ECHOCARDIOGRAPHY SHOWED MR INCREASED TO A GRADE OF 3-4. NO ADDITIONAL INFORMATION PROVIDED.

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

  MAUDE report 17620441 ↗
• InjuryJul 28, 2023Incomplete Coaptation; Incomplete Coaptation

  THIS IS FILED TO REPORT INCOMPLETE COAPTATION. IT WAS REPORTED THAT ON (B)(6) 2023, A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) WITH A GRADE OF 3. ONE CLIP WAS IMPLANTED, REDUCING MR TO A GRADE OF 1. ON (B)(6) 2023, AS THE ONE MONTH FOLLOW UP, ECHOCARDIOGRAPHY SHOWED THE IMPLANTED 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 3-4. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 17420129 ↗
• MalfunctionJul 26, 2023Leak/Splash; Leak/Splash

  THIS IS FILED TO REPORT A LEAK. IT WAS REPORTED THAT A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT MITRAL REGURGITATION (MR) GRADE 4. DURING PREPARATION OF THE NTW MITRACLIP (LOT: 30109R1026) SALINE WAS LEAKING THROUGH THE BASE OF THE LOCK LEVER MORE THAN USUAL. A REPLACEMENT NTW (LOT: 30109R1021) WAS USED TO COMPLETE THE PROCEDURE. THE CLIP WAS NOT IMPLANTED AS THE POSTERIOR LEAFLET WAS TOO SHORT FOR OPTIMAL INSERTION. THE PROCEDURE ENDED WITH MR UNCHANGED AT GRADE 4. THERE WERE NO PATIENT CONSEQUENCES OR CLINICALLY SIGNIFICANT DELAY. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17398408 ↗
• InjuryJul 25, 2023Incomplete Coaptation; Adverse Event Without Identified Device or Use Problem; Incomplete Coaptation; Adverse Event Without Identified Device or Use Problem

  THIS IS FILED TO REPORT INCOMPLETE COAPTATION AND WORSENING MITRAL REGURGITATION IT WAS REPORTED ON 4/29/2021, A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT MIXED MITRAL REGURGITATION (MR) WITH A GRADE OF 3. ONE NTW CLIP WAS IMPLANTED, REDUCING MR TO A GRADE OF 1. ON 7/6/2023, THE PATIENT RETURNED TO THE HOSPITAL. ECHOCARDIOGRAPHY SHOWED THE CLIP 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 3-4. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 17394173 ↗
• InjuryJul 17, 2023Incomplete Coaptation; Incomplete Coaptation

  THIS IS FILED TO REPORT A SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) AND INTERVENTION. IT WAS REPORTED THAT A PATIENT PRESENTED WITH GRADE 3-4 FUNCTIONAL MITRAL REGURGITATION (MR) AND CONCOMITANT TRICUSPID REGURGITATION (TR). DURING A MITRACLIP PROCEDURE, A SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) OCCURRED SHORTLY AFTER DEPLOYMENT OF AN NTW CLIP. AN ADDITIONAL NTW WAS PLACED TO STABILIZE THE SLDA. THE MR WAS REDUCED TO GRADE 2. FOR THE CONCOMITANT TR, 2 TRICLIP XTWS WERE PLACED ON THE TRICUSPID VALVE. DUE TO LOW CARDIAC OUTPUT AN INTRA-AORTIC BALLOON PUMP (IABP) WAS USED FOR SUPPORT. IT WAS UNABLE TO DETERMINE IF THE IABP WAS DUE TO LOW PRE-OPERATIVE LEFT VENTRICULAR EJECTION FRACTION (LVEF) OR IF THE SLDA CONTRIBUTED. THERE WAS NO ADVERSE PATIENT SEQUELAE OR CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17333899 ↗
• InjuryJul 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS FILED TO REPORT A PERICARDIAL EFFUSION. IT WAS REPORTED THIS WAS A MITRACLIP PROCEDURE TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) WITH A GRADE OF 4. AN NTW WAS INSERTED AND SUCCESSFULLY DEPLOYED ON THE MITRAL VALVE. DURING THE PROCEDURE, A PERICARDIAL EFFUSION (PE) OCCURRED. THE PE WAS MONITORED CLOSELY, AND THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE. IT WAS NOTED THE PHYSICIAN WAS UNABLE TO DETERMINE WHERE AND WHAT CAUSED THE PE. AFTERWARDS, PERICARDIOCENTESIS WAS PERFORMED AND MR WAS REDUCED TO A GRADE OF 1. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pericardial Effusion

  MAUDE report 17305730 ↗
• InjuryJun 22, 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) GRADE 3-4+ WITH AN ENLARGED ATRIUM AND ANNULUS. THE FIRST CLIP (30201R1020) WAS ADVANCED INTO THE PATIENT. THE LEAFLETS WERE GRASPED AND A LEAFLET TEAR WAS OBSERVED. THE CLIP WAS THEN REPOSITIONED AND IMPLANTED TO TREAT THE TEAR. A SECOND CLIP (20607R114) WAS THEN IMPLANTED TO FURTHER TREAT THE LEAFLET TEAR. HOWEVER, SHORTLY AFTER DEPLOYMENT OF THE SECOND CLIP, IT DETACHED FROM THE POSTERIOR LEAFLET AND REMAINED ATTACHED TO THE ANTERIOR LEAFLET (SINGLE LEAFLET DEVICE ATTACHMENT/SLDA). SHORTLY AFTER THE SLDA OCCURRED, THE STEERABLE GUIDE CATHETER (SGC) WAS INADVERTENTLY PULLED BACK INTO THE RIGHT ATRIUM (RA), RESULTING IN A RIGHT TO LEFT SHUNT. THE SGC WAS ADVANCED BACK INTO THE LEFT ATRIUM (LA) AND ONE ADDITIONAL CLIP WAS IMPLANTED TO STABILIZE THE SLDA. AFTER REMOVAL OF THE SGC, AN ATRIAL SEPTAL DEFECT (ASD) CLOSURE DEVICE WAS IMPLANTED. THE PROCEDURE WAS THEN CONCLUDED WITH A RESULTING MR OF GRADE 3+. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17188048 ↗
• MalfunctionJun 8, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THIS WILL BE FILED TO REPORT USE OF AN EXPIRED DEVICE. IT WAS REPORTED THAT A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT MITRAL REGURGITATION GRADE 4+ WITH ENLARGED ATRIA. ONE CLIP WAS IMPLANTED SUCCESSFULLY AND THE MR WAS REDUCED TO GRADE 1. ON (B)(6) 2023 THE ABBOTT EMPLOYEE WAS INFORMED THAT THE IMPLANTED CLIP WAS EXPIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17087780 ↗
• InjuryMay 25, 2023Unintended Movement; Unintended Movement

  THIS WILL BE FILED TO REPORT A CLIP THAT OPENED WHILE LOCKED. IT WAS REPORTED THAT ON (B)(6) 2021 A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) GRADE 4. ONE CLIP WAS IMPLANTED AND THE MR WAS REDUCED TO GRADE 1. ROUGHLY 18 MONTHS LATER, THE PATIENT RETURNED TO THE HOSPITAL. TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) WAS PERFORMED AND IT WAS OBSERVED THE CLIP HAD SLIGHTLY OPENED, CAUSING MR TO INCREASE TO A GRADE OF 3-4. ON (B)(6) 2023 A SECOND MITRACLIP PROCEDURE WAS PERFORMED. AN ADDITIONAL CLIP WAS THEN IMPLANTED, REDUCING MR TO A GRADE OF 1. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 17007726 ↗
• InjuryMay 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS FILED TO REPORT A PERICARDIAL EFFUSION, REQUIRING INTERVENTION. IT WAS REPORTED THAT A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 4. ONE CLIP WAS IMPLANTED WITH NO REPORTED ISSUE, REDUCING MR TO GRADE <1. AT THE END OF SUCCESSFUL PLACEMENT OF THE CLIP, PATIENT¿S BLOOD PRESSURE STARTED TO DROP. THE ANESTHESIOLOGIST HAD TO GIVE VASOPRESSORS FOR SUPPORT. ON ECHOCARDIOGRAM, A SMALL PERICARDIAL EFFUSION WAS NOTICED. HOWEVER, AT THAT TIME THE PHYSICIANS STATED IT WAS TOO SMALL TO TAP. PATIENT WAS SENT TO CT SCAN WHERE NO FURTHER BLEEDING WAS NOTED. NEXT DAY, IT WAS CONFIRMED THAT THE PATIENT HAD A PERICARDIAL EFFUSION. THE PATIENT IS STABLE AND CURRENTLY OFF ALL VASOPRESSORS. THE CLIP REMAINED STABLE ON THE LEAFLETS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Low Blood Pressure/ Hypotension; Pericardial Effusion

  MAUDE report 16993741 ↗
• DeathMay 24, 2023Difficult to Remove; Difficult to Remove

  THIS IS FILED TO REPORT DEATH. IT WAS REPORTED THAT A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT MITRAL REGURGITATION (MR). THE PATIENT PRESENTED WITH A SMALL HEART, MAXIMUM HEIGHT POSSIBLE FOR TRANS-SEPTAL PUNCTURE 3.4CM, RESTRICTED POSTERIOR LEAFLET, OPPOSING ANTERIOR LEAFLET FLAIL, LARGE COAPTATION GAP 8MM. DURING THE PROCEDURE, THE NTW CLIP GOT ENTANGLED IN CHORDAE. IN AN ATTEMPT TO FREE THE CLIP, PAPILLARY MUSCLE WAS RUPTURED. THE PATIENT EXPERIENCED CARDIAC TAMPONADE AND PERICARDIAL EFFUSION, REQUIRING EMERGENCY PERICARDIOCENTESIS. THE PATIENT DEVELOPED COMPLETE HEART BLOCK, VENTRICULAR TACHYCARDIA (VT) AND VENTRICULAR FIBRILLATION (VF), REQUIRING DEFIBRILLATION AND CARDIOPULMONARY RESUSCITATION (CPR). XTW CLIP WAS IMPLANTED LATERAL A2/P2. ANOTHER CLIP (NTW) WAS IMPLANTED A1/P1. MR WAS REDUCED TO GRADE 2. ON (B)(6)2023, THE PATIENT EXPERIENCED MULTI ORGAN FAILURE, PRIMARILY LIVER AND KIDNEY. THE PATIENT DEVELOPED ACUTE RENAL FAILURE AND DISSEMINATING INTRAVASCULAR COAGULATION (DIC) POST-OPERATION. PUPILS WERE FOUND TO BE BLOWN AND THE FAMILY ASKED FOR WITHDRAWAL OF TREATMENT. SUBSEQUENTLY, THE PATIENT EXPIRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Cardiac Arrest; Cardiac Tamponade; Hemorrhage/Blood Loss/Bleeding; Pericardial Effusion; Tachycardia; Unspecified Tissue Injury; Ventricular Fibrillation

  MAUDE report 16993419 ↗