MITRACLIP CDS0701-NTRecalls & reported problems

Summary

The FDA's MAUDE database contains 430 adverse event reports that list this exact device (DI 08717648230943), received between Dec 3, 2019 and Apr 11, 2025 — classified as 12 deaths, 240 injuries, 178 malfunctions.

The most frequently reported specific device problem is “Incomplete Coaptation” (88 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 430 reports, in the reporter's own words as published by the FDA.

• InjuryApr 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4) - EXPAND G4 PHASE 1 AND PHASE 2 STUDY: PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT PRESENTED WITH DEGENERATIVE MITRAL REGURGITATION (MR)WITH MITRAL ANNULAR CALCIFICATION. TWO MITRACLIPS WERE IMPLANTED, REDUCING THE NR TO GRADE 1+. THERE WAS NO DEVICE DEFICIENCY. ON (B)(6) 2022, MITRAL STENOSIS WAS NOTED ON A FOLLOW-UP ECHOCARDIOGRAM. THERE WAS NO TREATMENT PROVIDED. THERE WAS NO DEVICE MALFUNCTION.

  Patient problems: Mitral Valve Stenosis

  MAUDE report 21826081 ↗
• InjuryMar 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) - EXPAND G4 PHASE 1 AND PHASE 2 STUDY. PATIENT ID: (B)(6). IT WAS REPORTED THAT ON 15JUNE2021, THE PATIENT PRESENTED WITH MIXED MITRAL REGURGITATION (MR). TWO MITRACLIPS WERE SUCCESSFULLY IMPLANTED, REDUCING THE MR TO GRADE 1+. THERE WAS NO DEVICE DEFICIENCY. ON (B)(6) 2021, SEVERE MR WAS NOTED ON THE FOLLOW-UP IMAGING. PER PHYSICIAN, THE EVENT WAS NOT SERIOUS, AND THE PATIENTS¿ SYMPTOMS HAD IMPROVED. ON (B)(6) 2021, MITRAL VALVE STENOSIS WAS DIAGNOSED. THERE WAS NO ADDITIONAL TREATMENT, NO MEDICAL INTERVENTION, AND NO HOSPITALIZATION DUE TO THE EVENTS. THERE REMAINED NO MALFUNCTION.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation; Mitral Valve Stenosis

  MAUDE report 21721004 ↗
• InjuryMar 26, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  N/A

  Patient problems: Mitral Valve Stenosis

  MAUDE report 21700645 ↗
• InjuryOct 3, 2024Difficult or Delayed Positioning; Difficult or Delayed Positioning

  IT WAS REPORTED A MITRACLIP PROCEDURE WAS BEING PERFORMED TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 3-4 AND A P2 FLAIL. AN XTW CLIP WAS DEPLOYED AND IT WAS NOTED THAT THE CLIP HAD PERFORATED THE POSTERIOR LEAFLET AND WAS SLIGHTLY ANGLED WITH A SLIGHT ROCKING MOTION. A SECOND CLIP WAS USED DUE TO THE PERFORATION. A NT CLIP WAS ADVANCED INTO THE ANATOMY, GRASPING WAS PERFORMED AND REDUCED MR, HOWEVER THE PHYSICIAN WISHED TO TRY ANOTHER GRASP TO FURTHER REDUCE MR. UPON REGRASPING, IT WAS NOTED THAT MR HAD INCREASED. IT WAS ADDITIONALLY NOTED THAT THIS CLIP WAS TRAPPED IN CHORDAE, IT WAS ABLE TO BE REMOVED BUT NOTED TO HAVE BEEN DIFFICULT. THE CLIP WAS REMOVED FROM THE PATIENT ANATOMY. TWO ADDITIONAL XTW CLIPS WERE ATTEMPTED TO BE PLACED. MULTIPLE GRASPING ATTEMPTS AND CLIP MANIPULATION APPEARED TO CAUSE FURTHER DAMAGE TO THE MITRAL LEAFLETS AND THE SEVERITY OF THE MR INCREASED. THE MR INCREASED TO 3+ AFTER THE FIRST CLIP WAS USED, AND TO 4+ AFTER THE SECOND CLIP USED. THESE EVENTS RESULTED IN THE PATIENT BEING HEMODYNAMICALLY UNSTABLE, EXPERIENCING TACHYCARDIA AND A DROP IN BLOOD PRESSURE. AN IABP WAS INSERTED AND THEY WERE CONVERTED TO SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20363736 ↗
• InjuryMar 18, 2024Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THAT ON 23 FEBRUARY 2023, A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) GRADE 4. A XTW AND A NT CLIIP WERE IMPLANTED SUCCESSFULLY, REDUCING MR TO TRACE. ONE YEAR POST PROCEDURE, A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) FOLLOW UP SHOWED THE NT DETACHED FROM THE ANTERIOR LEAFLET SINGLE LEAFLET DEVICE ATTACHMENT (SLDA). PATIENT WAS NOT SYMPTOMATIC BUT LEFT VENTRICLE FUNCTION WAS LESS THAN 40% AND MR WAS RECURRENT GRADE 3-4. NO INTERVENTION WAS PERFORMED. SURGICAL INTERVENTION IS CONSIDERED. IT WAS THOUGHT SUBOPTIMAL MEDICAL MANAGEMENT LED FURTHER DILATION OF THE VALVE RESULTING IN THE SLDA.

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

  MAUDE report 18924158 ↗
• InjuryMar 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING FILED DUE TO WORSENING HEART FAILURE WITH RECURRENT MITRAL REGURGITATION, DEEMED DEVICE RELATED AND REQUIRING TREATMENT. CRD_1002 - EXPAND G4 PHASE 1 AND PHASE 2 STUDY PATIENT ID: (B)(6). IT WAS REPORTED THAT ON 08/19/2021, THE PATIENT PRESENTED WITH MIXED MITRAL REGURGITATION (MR) WITH ANTERIOR AND POSTERIOR LEAFLET PROLAPSE AND LEAFLET TETHERING. ONE MITRACLIP WAS SUCCESSFULLY IMPLANTED, REDUCING THE MR TO GRADE 1+. THERE WAS NO DEVICE DEFICIENCY. ON (B)(6) 2024, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH LOWER EXTREMITY EDEMA AND MILD SHORTNESS OF BREATH. WORSENING CONGESTIVE HEART FAILURE (CHF) WAS DIAGNOSED, TREATED WITH MEDICATIONS. DURING THIS HOSPITALIZATION, MITRAL VALVE STENOSIS, SEVERE MR, AND TRICUSPID VALVE REGURGITATION WITH MILD PULMONARY HYPERTENSION WERE DIAGNOSED. ON (B)(6) 2024, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR A SCHEDULED RIGHT HEART CATHETERIZATION. ELEVATED FILLING PRESSURES WITH EVIDENCE OF ACUTE HEART FAILURE EXACERBATION WERE REPORTED. MEDICATIONS WERE PROVIDED AS TREATMENT.

  Patient problems: Dyspnea; Heart Failure/Congestive Heart Failure; High Blood Pressure/ Hypertension; Mitral Valve Insufficiency/ Regurgitation; Mitral Valve Stenosis; Swelling/ Edema; Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 18862153 ↗
• InjuryMar 4, 2024Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THIS REPORT IS BEING FILED DUE TO RECURRENT MITRAL REGURGITATION. 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 DEGENERATIVE MITRAL REGURGITATION (MR) WITH POSTERIOR LEAFLET PROLAPSE. TWO MITRACLIPS WERE SUCCESSFULLY IMPLANTED, REDUCING THE MR TO GRADE 1+. THERE WAS NO DEVICE DEFICIENCY. ON (B)(6)2022, RECURRENT MR GRADE 2+ WAS NOTED ON A FOLLOW-UP. THE INCREASE WAS DEEMED DEVICE RELATED. AN UNSPECIFIED DEVICE ISSUE WAS NOTED. IT WAS NOT SPECIFIED WHICH CLIP THE ISSUE WAS ASSOCIATED WITH. THERE WAS NO UNPLANNED HOSPITALIZATION AND NO TREATMENT.

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

  MAUDE report 18826038 ↗
• InjuryOct 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS FILED TO REPORT MITRAL STENOSIS 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) WITH A2 FLAIL. TWO MITRACLIPS (CDS0701-NTW, 00929U205 AND CDS0701-NT, 10108U275) WERE IMPLANTED, REDUCING THE MR TO GRAD 1+. THERE WAS NO COMPLICATION AND NO DEVICE DEFICIENCY. ON (B)(6) 2023, MITRAL VALVE STENOSIS WITH CASCADING PULMONARY HYPERTENSION WAS DIAGNOSED. THE STENOSIS WILL BE MONITORED. MODERATE MR (GRADE 2+) WAS ALSO NOTED. ON (B)(6) 2023, A SCHEDULED RIGHT HEART CATHETERIZATION WAS PERFORMED. MODERATE MITRAL STENOSIS AND PULMONARY HYPERTENSION WERE OBSERVED. THE MITRAL VALVE HAD THICKENED LEAFLETS WITH ECCENTRIC MODERATE MR. THE ELEVATED PRESSURES INDICATED VOLUME OVERLOAD AND WORSENING HEART FAILURE WAS DIAGNOSED. MEDICATIONS WERE PROVIDED AS TREATMENT. THERE WAS NO ADDITIONAL HOSPITALIZATION. THE CONDITIONS ARE CHRONIC WITH SEQUELA. PER PHYSICIAN, THE RECURRENT MR (GRADE 2+) WAS UNRELATED TO THE MITRACLIPS. THERE WAS NO DEVICE MALFUNCTION. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: High Blood Pressure/ Hypertension; Mitral Valve Stenosis

  MAUDE report 17916568 ↗
• InjuryOct 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS FILED TO REPORT RECURRENT MR, TISSUE DAMAGE, INTERVENTION, AND PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT A PATIENT PRESENTED WITH GRADE 4+ DEGENERATIVE MITRAL REGURGITATION (MR). ON (B)(6) 2022, A MITRACLIP PROCEDURE WAS PERFORMED AND ONE NT WAS IMPLANTED. THE MR WAS REDUCED FROM GRADE 4+ TO 2+. ON (B)(6) 2023, THE PATIENT PRESENTED WITH RECURRENT MR AT GRADE 4+. ADDITIONALLY THERE WAS OBSERVED TISSUE DAMAGE FROM THE MITRACLIP. THE PHYSICIAN COULD NOT CONFIRM IF DISEASE PROGRESSION WAS THE CAUSE, AS THE FIRST INTERVENTION WAS A DIFFERENT INSTITUTION. ONE XTW WAS IMPLANTED TO REDUCE THE MR TO GRADE 1-2+. THERE WERE NO ADVERSE PATIENT SEQUELAE. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 17885852 ↗
• DeathJun 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING CONSERVATIVELY FILED TO REPORT THE DEATH. CRD_1002 - EXPAND G4 PHASE 1 AND PHASE 2 STUDY: PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT PRESENTED WITH DEGENERATIVE MITRAL REGURGITATION (MR) GRADE 4+ WITH A POSTERIOR LEAFLET PROLAPSE, MITRAL ANNULAR CALCIFICATION. ONE MITRACLIP WAS SUCCESSFULLY IMPLANTED, REDUCING THE MR TO GRADE 2+. ON (B)(6) 2022, THE PATIENT HAD BEEN HOSPITALIZED WITH HYPOXIA. ON (B)(6) 2022, THE PATIENT PASSED AWAY DUE TO A CARDIOVASCULAR RELATED DEATH. PER PHYSICIAN, THE EVENT WAS UNKNOWN IF DEVICE RELATED. THREE ATTEMPTS WERE MADE TO OBTAIN INFORMATION WITHOUT SUCCESS. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 17208270 ↗
• InjuryMay 23, 2023Incomplete Coaptation; Incomplete Coaptation

  THIS IS FILED TO REPORT THE MITRACLIP DETACHING FROM THE ANTERIOR LEAFLET REQUIRING INTERVENTION. IT WAS REPORTED THAT A MITRACLIP PROCEDURE WAS PERFORMED ON (B)(6) 2023 TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) GRADE 3-4. TWO MITRACLIPS WERE IMPLANTED ON THE MITRAL VALVE, REDUCING MR TO GRADE 1. ON (B)(6) 2023 THE PATIENT RETURNED WITH RECURRENT MR GRADE 3-4 AND THE FIRST IMPLANTED NT CLIP (20504R108) WAS DETACHED FROM THE ANTERIOR LEAFLET (SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) DUE TO SUSPECTED LEAFLET TEARING. THE CLIP REMAINED ONLY ATTACHED TO CHORDAE ON THE ANTERIOR SIDE. A XT CLIP WAS IMPLANTED TO STABILIZE THE DETACHED CLIP, REDUCING MR TO GRADE 3. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 16988691 ↗
• MalfunctionMay 10, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THIS IS FILED TO REPORT USE AFTER EXPIRATION. IT WAS REPORTED THIS WAS A MITRACLIP PROCEDURE TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) WITH A GRADE OF 4. ONE CLIP WAS SUCCESSFULLY IMPLANTED, REDUCING MR TO A GRADE OF 1. HOWEVER, AFTER THE PROCEDURE, IT WAS RECOGNIZED THAT THE IMPLANTED CLIP WAS EXPIRED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16908527 ↗
• InjuryApr 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING FILED DUE TO MITRAL STENOSIS. 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 CHRONIC, ISCHEMIC MIXED MODERATE MITRAL REGURGITATION (MR), WITH ANTERIOR LEAFLET PROLAPSE. TWO MITRACLIPS WERE IMPLANTED, REDUCING THE MR TO GRADE 1+. POST-PROCEDURE, THE GRADIENT WAS NOTED AT 13MMHG. ON (B)(6) 2021, A FOLLOW-UP ECHOCARDIOGRAM WAS PERFORMED. THE MEAN MITRAL VALVE GRADIENT REMAINED ELEVATED AT 8MMHG. MITRAL STENOSIS WAS DIAGNOSED. NO TREATMENT WAS REPORTED. ON (B)(6) 2022, WORSENING PULMONARY HYPERTENSION WAS DIAGNOSED. REPORTEDLY, THE PATIENT HAS A HISTORY OF OBSTRUCTIVE SLEEP APNEA AND IS COMPLIANT WITH CPAP MACHINE. PER PHYSICIAN, THE HYPERTENSION WAS DEVICE RELATED. THERE WAS NO DEVICE MALFUNCTION. THERE WAS NO ADDITIONAL HOSPITALIZATION AND NO TREATMENT PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: High Blood Pressure/ Hypertension; Mitral Valve Stenosis

  MAUDE report 16787614 ↗
• InjuryApr 3, 2023Difficult or Delayed Positioning; Positioning Failure; Difficult or Delayed Positioning; Positioning Failure

  THIS IS FILED TO REPORT TISSUE DAMAGE IT WAS REPORTED THIS WAS A MITRACLIP PROCEDURE TO TREAT MIXED MITRAL REGURGITATION (MR) WITH A GRADE OF A 4+. IT WAS NOTED A LEFT VENTRICLE (LV) ANEURYSM MADE IMAGING. TWO CLIPS WERE DEPLOYED ON THE MITRAL VALVE, REDUCING MR TO A GRADE OF 1-2. A THIRD CLIP (20504R141) WAS INSERTED, AND GRASPING WAS PERFORMED. HOWEVER, DUE TO THE LV ANEURYSM, POSTERIOR POSITION AND WAS DIFFICULT, RESULTING IN DIFFICULT GRASPING AND CAPTURING THE LEAFLETS. IT WAS THEN OBSERVED THE TISSUE DAMAGE ON THE POSTERIOR LEAFLET OCCURRED, CAUSING MR TO INCREASE TO A GRADE OF 3-4. THEREFORE, THE CLIP WAS REMOVED AND REPLACED. A FOURTH CLIP (20613R144) WAS INSERTED AND DEPLOYED ON THE MITRAL VALVE. IT WAS NOTED THAT DUE TO IMAGING, GRASPING WAS DIFFICULT. AFTER DEPLOYMENT, IT WAS OBSERVED MR HAD INCREASED TO A GRADE OF 4+. THE PHYSICIAN STATED THE FOURTH CLIP DID NOT CAUSE ANY TISSUE DAMAGE AND THE MR RETURNING TO A GRADE OF 4+ WAS DUE TO THE DAMAGE CAUSED BY THE THIRD CLIP. THE DECISION WAS THEN MADE TO TO DISCONTINUE THE PROCEDURE. 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 16669897 ↗
• InjuryMar 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS FILED TO REPORT TISSUE DAMAGE AND SURGICAL INTERVENTION. IT WAS REPORTED THAT A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) GRADE 4+ WITH FLAIL, RESTRICTED POSTERIOR AND ANTERIOR LEAFLETS, AND DENSE CHORDAE. THE FIRST CLIP (NTW) WAS ADVANCED TO THE MITRAL VALVE AND GRASPED THE LEAFLETS; BUT THE PHYSICIAN WAS NOT SATISFIED WITH THE LOCATION. THE NTW WAS MOVED LATERALLY SEVERAL TIMES. AT SOME POINT, THE CLIP GOT STUCK ON THE ANTERIOR LEAFLET BUT WAS ABLE TO BE FREED. THE DECISION WAS MADE TO REMOVE THE DEVICE. HOWEVER, WHILE REMOVING THE CLIP, A SMALL FLAIL WAS CAUSED. THE SHAFT OF THE CLIP WAS NOTED TO BE BENT. A SECOND CLIP (NTW) WAS INSERTED. THE CLIP CAPTURED THE FLAIL AND MR LOOKED GOOD. HOWEVER, THE VALVE LOOKED LIKE IT WAS FALLING APART. THE CHORDS KEPT POPPING WHEN GRASPING. THE SECOND NTW WAS DEPLOYED WITH SOME RESIDUAL MR. A THIRD CLIP (NT) WAS PLACED NEXT TO THE SECOND NTW. IN DOING SO, THIS CAUSED MORE OF A FLAIL. THE VALVE LOOKED LIKE IT WAS DETERIORATING. THE THIRD CLIP WAS IMPLANTED. IT WAS NOTED THAT THERE WAS MORE MOBILITY ON THE SECOND CLIP. THE PROCEDURE WAS ABORTED, AND THE PATIENT WENT INTO SURGERY FOR A MITRAL VALVE RE

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16656937 ↗
• DeathMar 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING CONSERVATIVELY FILED DUE TO A PATIENT DEATH, UNKNOWN IF DEVICE RELATED. PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT PRESENTED WITH FUNCTIONAL MITRAL REGURGITATION (MR) GRADE 4+. ONE MITRACLIP WAS IMPLANTED, REDUCING THE MR TO GRADE 2+. THERE WAS NO DEVICE DEFICIENCY. ON (B)(6) 2023, THE PATIENT PASSED AWAY DUE TO AN UNKNOWN CAUSE. REPORTEDLY, ADDITIONAL DETAILS WERE NOT AVAILABLE AT THIS TIME. THERE WAS NO DEVICE MALFUNCTION NOTED. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 16644294 ↗
• MalfunctionMar 22, 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 DURING PREPARATION, THE GRIPPERS ISSUE OCCURRED. TROUBLESHOOTING WAS PERFORMED, BUT THE ISSUE WAS UNABLE TO BE RESOLVED. THEREFORE, THE CLIP WAS NOT USED AND WAS REPLACED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16591544 ↗
• DeathMar 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT PRESENTED WITH SEVERE MITRAL REGURGITATION (MR). ONE MITRACLIP (CDS0701XTW, 10416R106) WAS IMPLANTED WITHOUT AN ISSUE REPORTED, REDUCING THE MR TO APPROXIMATELY GRADE 1+. ON THE DISCHARGE ECHOCARDIOGRAM, THE MR WAS NOTED AT MODERATE TO SEVERE. THE PATIENT REMAINED STABLE, WITHOUT COMPLAINTS. REPORTEDLY, THE PATIENT WAS DOING WELL AND IN STABLE CONDITION. PER HISTORY AND PHYSICAL DATED (B)(6) 2021, THE PATIENTS SYMPTOMS HAD NOT IMPROVED FOLLOWING THE INDEX PROCEDURE. PER IMAGING, THERE MIGHT HAVE BEEN A TEAR IN THE VALVE. ON (B)(6) 2021, THE PATIENT PRESENTED WITH RECURRENT, SEVERE MR. ANOTHER MITRACLIP (CDS0701-NT 10227R117) WAS IMPLANTED MEDIAL TO THE PREVIOUSLY IMPLANTED CLIP, REDUCING THE MR TO GRADE 1+. THERE WAS NO DEVICE DEFICIENCY. NOTE-THE RECURRENT MR NOTED ON DISCHARGE AND SECOND CLIP PROCEDURE ARE CAPTURED AND REPORTED IN ANOTHER EVENT/COMPLAINT (B)(4). INITIAL MDR 2024168-2021-07102-00 AND FOLLOW-UP MDR 2024168-2021-07102-01 WILL BE SENT. ON (B)(6) 2022, THE PATIENT PASSED AWAY WHILE AT HOME. REPORTEDLY, THE DEATH WAS OF CARDIOVASCULAR ORIGIN, AND UNKNOWN IF DEVICE RELATED. PER ACCOUNT, ADDITIONAL DETA

  Patient problems: Unspecified Heart Problem

  MAUDE report 16521947 ↗
• InjuryMar 8, 2023Incomplete Coaptation; Incomplete Coaptation

  THIS IS FILED TO REPORT A SINGLE LEAFLET DEVICE ATTACHMENT. IT WAS REPORTED THAT THIS WAS A MITRACLIP PROCEDURE TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) WITH A GRADE OF 4, A RESTRICTED POSTERIOR LEAFLET, AND OFF AXIS HEART. WHILE INSERTING THE CLIP DELIVERY SYSTEM (CDS) INTO THE STEERABLE GUIDE CATHETER (SGC), TOO MUCH AIR WAS OBSERVED IN THE HEMOSTATIC VALVE. ASPIRATION WAS PERFORMED TO REMOVE THE AIR FROM THE SGC. DUE TO THE LEAK, THE SGC WAS REMOVED AND REPLACED. ONE CLIP WAS SUCCESSFULLY DEPLOYED ON THE MITRAL VALVE WITHOUT ISSUES. TO FURTHER REDUCE MR, AN NT CLIP WAS INSERTED AND DEPLOYED. HOWEVER, AFTER DEPLOYMENT, THE CLIP DETACHED FROM THE ANTERIOR LEAFLET AND REMAINED ATTACHED TO THE POSTERIOR LEAFLET (SINGLE LEAFLET DEVICE ATTACHMENT/SLDA). TO STABILIZE THE SLDA, AN ADDITIONAL CLIP WAS IMPLANTED, REDUCING MR TO A GRADE OF 2. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16507408 ↗
• MalfunctionMar 8, 2023Incomplete Coaptation; Incomplete Coaptation

  THIS IS FILED TO REPORT A SINGLE LEAFLET DEVICE ATTACHMENT. IT WAS REPORTED THIS WAS A MITRACLIP PROCEDURE TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 4+ AND A THIN ANTERIOR LEAFLET. IT WAS NOTED THAT IMAGING WAS CHALLENGING. AN XTW CLIP WAS INSERTED AND DEPLOYED ON THE MITRAL VALVE, REDUCING MR TO A GRADE OF 1-2+. TO FURTHER REDUCE MR, AN NT CLIP WAS INSERTED, AND GRASPING WAS PERFORMED. IT WAS NOTED THAT IT WAS DIFFICULT TO CONFIRM IF THE ANTERIOR LEAFLET WAS FULLY INSERTED IN THE CLIP. EVEN THOUGH IT WAS DIFFICULT TO CONFIRM, THE PHYSICIAN DECIDED TO CONTINUE WITH DEPLOYED. AFTER DEPLOYMENT, THE CLIP DETACHED FROM THE ANTERIOR LEAFLET AND REMAINED ATTACHED TO THE POSTERIOR LEAFLET (SINGLE LEAFLET DEVICE ATTACHMENT/SLDA). MR REMAINED AT A GRADE OF 1-2+. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16503204 ↗
• MalfunctionMar 6, 2023Unintended Movement; Unintended Movement

  THIS WILL BE FILED TO REPORT THE CLIP OPENING WHILE ESTABLISHING FINAL ARM ANGLE (EFAA). IT WAS REPORTED THAT A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) WITH A GRADE OF 4. ONE CLIP WAS IMPLANTED WITH NO REPORTED ISSUE. ANOTHER CLIP WAS ADVANCED TO THE MITRAL VALVE. THE CLIP OPENED TO 30-40 DEGREES WHILE ESTABLISHING FINAL ARM ANGLE (EFAA). IT WAS DECIDED TO REMOVE THE CLIP. TWO MORE CLIPS WERE IMPLANTED WITH NO REPORTED ISSUE, REDUCING MR TO GRADE 1-2. 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 16485076 ↗
• InjuryMar 3, 2023Difficult or Delayed Positioning; Difficult to Remove; Difficult or Delayed Positioning; Difficult to Remove

  THIS IS FILED TO REPORT DIFFICULTY RETRACTING THE CLIP CAUSING TISSUE DAMAGE. IT WAS REPORTED THAT A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) GRADE 4+ WITH A DILATED LEFT VENTRICLE, AND A RESTRICTED AND CLEFT POSTERIOR LEAFLET . IT WAS NOTED DURING THE DEPLOYMENT PROCESS WITH THE FIRST CLIP (20615R185), A KNOT WAS FOUND IN THE LOCK LINE. THE LOCK LINE WAS REMOVED FROM THE OPPOSITE END WITHOUT COMPLICATION AND THE CLIP WAS DEPLOYED SUCCESSFULLY. SHORTLY AFTER, A SMALL FLAIL WAS NOTED. A SECOND CLIP (20217R173) WAS THEN PREPARED AND ADVANCED INTO THE PATIENT TO FURTHER REDUCE MR. DIFFICULTY GRASPING WAS EXPERIENCED SO THE PHYSICIAN ELECTED TO RETRACT THE CLIP BACK INTO THE LEFT ATRIUM. AT THIS TIME A LARGER FLAIL WAS OBSERVED. IT WAS SUSPECTED THAT THERE WAS CHORDAL INTERACTION WITH THIS CLIP WHEN RETRACTING INTO THE LEFT ATRIUM. THE CLIP WAS THEN IMPLANTED TO TREAT THE FLAIL. IT WAS ALSO NOTED THAT THE FLAIL WAS ATTRIBUTED TO THE PATIENT HAVING FRIABLE AND DISEASED TISSUE. THE PROCEDURE WAS CONCLUDED WITH A RESULTING MR OF GRADE 2+. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT SEQUELAE. NO ADDITIONAL INFORMA

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16483097 ↗
• InjuryMar 3, 2023Difficult to Remove; Difficult to Remove

  THIS IS FILED TO REPORT TISSUE INJURY. IT WAS REPORTED THAT A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH GRADE 4 AND A PROLAPSED ANTERIOR LEAFLET. IT WAS NOTED THE PRE-PROCEDURE GRADIENT WAS 2MMHG. AN NTW CLIP WAS DEPLOYED AT A3/P3, REDUCING MR TO GRADE 1-2. AN NT CLIP WAS THEN INSERTED AND GRASPING WAS PERFORMED. HOWEVER, IT AS OBSERVED THE GRADIENT INCREASED TO 12MMHG. THE CLIP WAS REPOSITIONED, BUT BECAME CAUGHT IN CHORDAE, RESULTING IN A FLAILED CHORDAE. THIS CAUSED MR TO SLIGHTLY INCREASE TO A GRADE OF 3. THE CLIP WAS REMOVED FROM THE CHORDAE AND GRASPING WAS AGAIN PERFORMED. HOWEVER, THE GRADIENT WAS 11MMHG. THEREFORE, THE CLIP WAS REMOVED AND PROCEDURE WAS DISCONTINUED. IT WAS NOTED THE GRADIENT RETURNED TO 3MMHG. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 16482936 ↗
• InjuryMar 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING FILED DUE TO CHEST PAIN AND ARRHYTHMIAS, REQUIRING TREATMENT, UNKNOWN OF DEVICE RELATED. PATIENT ID: (B)(6). IT WAS REPORTED THAT ON(B)(6) 2021, THE PATIENT PRESENTED WITH MIXED MITRAL REGURGITATION WIT LEAFLET TETHERING. TWO MITRACLIPS HAD BEEN IMPLANTED, REDUCING THE MR TO GRADE 2+. THERE WAS NO DEVICE DEFICIENCY. STARTING ON (B)(6) 2023, THE PATIENT EXPRESSED EXPERIENCING CHEST PAIN. ON (B)(6) 2023, THE PATIENT WAS HOSPITALIZED FOR THE CHEST PAIN. PER IMAGING, THE PATIENTS HEART RATE WAS TACHYCARDIC AT 130-140¿S. SUPRAVENTRICULAR TACHYCARDIA, ATRIAL FIBRILLATION, WITH AN IRREGULAR RHYTHM WAS NOTED. MEDICATIONS AND OXYGEN WERE PROVIDED AS TREATMENT. PER PHYSICIAN, THE EVENTS ARE UNKNOWN IF DEVICE RELATED. THERE WAS NO DEVICE MALFUNCTION REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

  Patient problems: Angina; Atrial Fibrillation; Tachycardia

  MAUDE report 16460262 ↗
• InjuryFeb 28, 2023Difficult or Delayed Positioning; Premature Activation; Difficult to Open or Close; Difficult or Delayed Positioning; Premature Activation; Difficult to Open or Close

  THIS IS FILED TO REPORT A CLIP CAUGHT IN CHORDAE, INABILITY TO OPEN THE CLIP, PREMATURE ACTIVATION, AND SURGICAL INTERVENTION. IT WAS REPORTED THAT ON (B)(6) 2021 A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT MIXED MITRAL REGURGITATION (MR) WITH GRADE OF 4+. ONE CLIP WAS IMPLANTED WITH NO REPORTED ISSUE, REDUCING MR TO GRADE 1-2+. ON (B)(6) 2023, A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT RECURRENT MR OF GRADE 4+. DIFFICULTY TO ADVANCE THE STEERABLE GUIDE CATHETER (SGC) WAS NOTED DUE TO PATIENT¿S ANATOMY. AN NT CLIP WAS ADVANCED LATERAL TO THE PREVIOUSLY IMPLANTED CLIP. AFTER GRASPING LEAFLETS, IT WAS NOTED THAT THE ANTERIOR LEAFLET WAS FULLY INSERTED, BUT SUFFICIENT INSERTION OF THE POSTERIOR LEAFLET WAS NOT ACHIEVED. THE CLIP WAS OPENED TO 120 DEGREES AND ATTEMPTED TO GRASP THE POSTERIOR LEAFLET BUT WAS MET WITH RESISTANCE. THE PHYSICIAN SUSPECTED THAT THE RESISTANCE WAS DUE TO THE CLIP BEING STUCK ON THE ANTERIOR LEAFLET. AFTER SOME MANIPULATION, NO RESISTANCE WAS FELT; HOWEVER, THE CLIP WAS THEN UNABLE TO OPEN PAST 180 DEGREES. THE PHYSICIAN NOTED THAT THE CLIP WOULD NOT MOVE WHEN TURNING THE ARM POSITIONER. IT WAS THEN REALIZED THAT THE CLIP HAD DETACHED FROM THE CLIP DELIVER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16454737 ↗