MITRACLIP CDS0701-XTWRecalls & reported problems

Summary

The FDA's MAUDE database contains 1,524 adverse event reports that list this exact device (DI 08717648231001), received between Dec 6, 2019 and Apr 13, 2026 — classified as 33 deaths, 869 injuries, 622 malfunctions.

The most frequently reported specific device problem is “Incomplete Coaptation” (440 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 1,524 reports, in the reporter's own words as published by the FDA.

• InjuryApr 13, 2026Migration

  IT WAS REPORTED THAT ON (B)(6) 2023, A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 4 ON A PATIENT WITH A PRE-EXISTING FLAIL AND FRIABLE LEAFLETS. A MITRACLIP XTW WAS IMPLANTED, REDUCING MR TO A GRADE OF 2-3. ON (B)(6) 2026, THE PATIENT RETURNED TO THE HOSPITAL WITH SYMPTOMS OF SHORTNESS OF BREATH. AN ECHOCARDIOGRAM WAS PERFORMED AND REVEALED THAT THE CLIP HAD PARTIALLY DETACHED FROM THE POSTERIOR LEAFLET AND REMAINED FULLY ATTACHED TO THE ANTERIOR LEAFLET (PARTIAL CLIP MOVEMENT), CAUSING MR TO INCREASE TO A GRADE OF 4. IT WAS NOTED THAT THE NEW ISSUE WAS ATTRIBUTED TO DETERIORATION OF LEAFLET QUALITY, AND THAT THE FLAIL HAD GOTTEN WORSE SINCE THE FIRST PROCEDURE. A SECOND MITRACLIP PROCEDURE WAS PERFORMED, AND TWO CLIPS WERE IMPLANTED, REDUCING MR TO A GRADE OF 1-2.

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

  MAUDE report 24866631 ↗
• InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  N/A.

  Patient problems: Dyspnea

  MAUDE report 23662664 ↗
• InjuryApr 18, 2025Off-Label Use; Incomplete Coaptation; Off-Label Use; Incomplete Coaptation

  IT WAS REPORTED ON (B)(6) 2022 A PATIENT PRESENTED WITH GRADE 4 DEGENERATIVE TRICUSPID REGURGITATION (TR) AND CONGENITAL HEART DISEASE FOR A MITRACLIP PROCEDURE. TWO MITRACLIPS WERE IMPLANTED OFF-LABEL. ON AN UNKNOWN DATE THE PATIENT PRESENTED WITH SHORTNESS OF BREATH. A SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) WAS OBSERVED WITH ONE OF THE TWO CLIPS. THE CLIP DETACHED FROM THE LATERAL LEAFLET AND REMAINED ATTACHED TO THE SEPTAL LEAFLET. THE TR GRADE INCREASED TO 5. ON (B)(6) 2025 A SECOND CLIP INTERVENTION WAS PERFORMED. ONE MITRACLIP WAS DEPLOYED IN BETWEEN THE PREVIOUS TWO CLIPS AND STABILIZED THE CLIP THAT SLDA. THE FINAL TR GRADE WAS 2-3.

  Patient problems: Dyspnea; Tricuspid Valve Insufficiency/ Regurgitation

  MAUDE report 21865890 ↗
• InjuryJan 6, 2025Adverse 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) 2022, THE PATIENT PRESENTED WITH MIXED MITRAL REGURGITATION WITH POSTERIOR LEAFLET PROLAPSE. ONE MITRACLIP WAS IMPLANTED, REDUCING THE MR TO GRADE 1+. THERE WAS NO DEVICE DEFICIENCY. ON (B)(6) 2024, A FOLLOW-UP ECHOCARDIOGRAM WAS PERFORMED. RECURRENT MR GRADE 2+ AND A MEAN MITRAL VALVE GRADIENT OF 6.4MMHG WAS NOTED. ON (B)(6)2024, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH SHORTNESS OF BREATH AND ACUTE ON CHRONIC CONGESTIVE HEART FAILURE WAS DIAGNOSED. PER IMAGING, SEVERE PULMONARY HYPERTENSION, ALONG WITH MODERATE MITRAL STENOSIS WITH AN ELEVATED BNP LAB (HEART FAILURE) HAD BEEN NOTED. MEDICATIONS WERE PROVIDED AS TREATMENT. THE PATIENT HAD A DROP IN HEMOGLOBIN AND ADDITIONAL GASTROINTESTINAL WORK-UP IS ONGOING. THERE WAS NO OVERT BLEEDING OBSERVED. THERE WAS NO INDICATION THE HEMOGLOBIN DROP WAS CARDIAC-DEVICE RELATED. THERE WAS NO DEVICE MALFUNCTION. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

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

  MAUDE report 21083829 ↗
• MalfunctionDec 23, 2024Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THIS WAS A MITRACLIP PROCEDURE TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) WITH A GRADE OF 4. AN XTW CLIP WAS PREPARED PER THE INSTRUCTIONS FOR USE (IFU) AND INSERTED WITHOUT ISSUES. HOWEVER, WHILE IN THE VALVE, IT WAS OBSERVED THAT ONE GRIPPER WAS NOT FUNCTIONING AS INTENDED. TROUBLESHOOTING WAS PERFORMED, BUT THE ISSUE WAS UNABLE TO BE RESOLVED. THEREFORE, THE CLIP WAS REMOVED AND REPLACED. TWO CLIPS WERE THEN DEPLOYED, REDUCING MR TO A GRADE OF 1. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21005036 ↗
• InjuryNov 11, 2024Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2022, A PATIENT PRESENTED WITH GRADE 4 DEGENERATIVE MITRAL REGURGITATION (MR) AND A PROLAPSED POSTERIOR LEAFLET FOR A MITRACLIP PROCEDURE. ONE CLIP WAS IMPLANTED AND THE MR WAS REDUCED TO GRADE 1. ON (B)(6) 2022, DURING AN ECHOCARDIOGRAPHIC REVIEW OF THE TRICUSPID VALVE, A PARTIAL LEAFLET DETACHMENT WAS OBSERVED FROM THE POSTERIOR LEAFLET. THE MR GRADE WAS 3+ AND NO TREATMENT WAS PERFORMED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 20659470 ↗
• InjuryNov 1, 2024Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THAT ON (B)(6) 2022, 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 2. ROUGHLY TWO YEARS AFTER THE CLIP WAS IMPLANTED, 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.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 20588762 ↗
• InjuryOct 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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: Low Blood Pressure/ Hypotension; Mitral Valve Insufficiency/ Regurgitation; Tachycardia; Unspecified Tissue Injury

  MAUDE report 20363636 ↗
• InjuryOct 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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: Low Blood Pressure/ Hypotension; Mitral Valve Insufficiency/ Regurgitation; Tachycardia; Unspecified Tissue Injury

  MAUDE report 20363556 ↗
• InjuryOct 3, 2024Migration; Migration

  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: Unspecified Tissue Injury

  MAUDE report 20363068 ↗
• InjurySep 13, 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 DEGENERATIVE MITRAL REGURGITATION (MR) GRADE 4+ WITH BILEAFLET PROLAPSE. TWO MITRACLIPS WERE IMPLANTED, REDUCING THE MR TO GRADE 2+. ON 14AUG2024, MITRAL VALVE STENOSIS WAS DIAGNOSED. NO TREATMENT WAS PROVIDED. THERE WAS NO DEVICE MALFUNCTION, AND THE EVENT WAS DEEMED UNRELATED TO THE DEVICE. ALTHOUGH DEEMED UNRELATED, THIS EVENT WAS CONSERVATIVELY CAPTURED AGAINST THE MITRACLIP DEVICE AS IT IS A NEW CONDITION POST IMPLANT.

  Patient problems: Mitral Valve Stenosis

  MAUDE report 20211686 ↗
• InjuryAug 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING FILED DUE TO RECURRENT 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 DEGENERATIVE MITRAL REGURGITATION (MR) WITH A POSTERIOR LEAFLET PROLAPSE AND FLAIL. ONE MITRACLIP WAS IMPLANTED, REDUCING THE MR TO GRADE 1+. ON (B)(6) 2024, RECURRENT MR WAS NOTED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 20014396 ↗
• InjuryAug 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT PRESENTED WITH GRADE 4 FUNCTIONAL MITRAL REGURGITATION. TWO XTW MITRACLIPS WERE IMPLANTED ON (B)(6) 2020. THE MR WAS REDUCED TO GRADE 1-2. DUE TO RECURRENT GRADE 3 MR, ANOTHER CLIP WAS IMPLANTED ON (B)(6) 2024. THERE WAS NO MOVEMENT OF THE CLIPS THAT WERE IMPLANTED IN THE FIRST PROCEDURE. BOTH CLIPS REMAINED STABLE ON THE LEAFLETS. THE MR WAS REDUCED TO GRADE <1. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 19961419 ↗
• InjuryJul 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) WITH A GRADE OF 4. AN XTW CLIP SUCCESSFULLY DEPLOYED ON THE MITRAL VALVE, REDUCING MR TO A GRADE OF 1-2. ON (B)(6) 2024, ECHOCARDIOGRAPHY SHOWED THE IMPLANTED CLIP HAD PERFORATED THE POSTERIOR LEAFLET, CAUSING MR TO SLIGHTLY INCREASE TO A GRADE OF 2+. IT WAS NOTED THE CLIP REMAINED STABLE ON BOTH LEAFLETS.

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

  MAUDE report 19794991 ↗
• InjuryApr 8, 2024Migration; Migration

  IT WAS REPORTED THAT ON (B)(6)2021, A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT MITRAL REGURGITATION GRADE 4. A XTW (LOT: 00718U307) WAS IMPLANTED SUCCESSFULLY, REDUCING MR TO GRADE 2. FOUR WEEKS AFTER THE PROCEDURE, MR WAS RECURRENT GRADE 4 DUE TO A TORN POSTERIOR LEAFLET. THE CLIP REMAINED SECURELY ATTACHED TO THE ANTERIOR LEAFLET. NO INTERVENTION WAS PERFORMED AT THE TIME. ON (B)(6)2024, A MITRACLIP RE-INTERVENTION WAS PERFORMED TO TREAT SEVERE DEGENERATIVE MITRAL REGURGITATION CAUSING SEVERE DYSPNEA. THE ORIGINAL ORIGINAL XTW CLIP (00718U307) WAS ATTACHED TO THE ANTERIOR LEAFLET BUT THERE WAS A SMALL AMOUNT OF POSTERIOR LEAFLET GRASPED. A NTW MITRACLIP (LOT; 31108R1106) WAS ATTEMPTED TO BE IMPLANTED. AFTER MULTIPLE UNSUCCESSFUL ATTEMPTS AT GRASPING AND CAPTURING THE LEAFLETS, THE CLIP WAS REMOVED. A REPLACEMENT XTW (LOT: 31113R1022) WAS IMPLANTED SUCCESSFULLY LATERAL TO THE ORIGINAL XTW CLIP (00718U307). THE PROCEDURE ENDED WITH MR REDUCED TO GRADE 2.

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

  MAUDE report 19068026 ↗
• InjuryApr 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT PRESENTED WITH GRADE 4 DEGENERATIVE MITRAL REGURGITATION (MR) FOR A MITRACLIP PROCEDURE. ON (B)(6) 2022, ONE MITRACLIP XTW WAS IMPLANTED AND THE MR WAS REDUCED TO GRADE LESS THAN 1. ON (B)(6) 2022, THE MR WAS RECURRENT AT GRADE 3+ (MODERATE-SEVERE), AND NO DISEASE MECHANISM WAS NOTED IN THE DISCHARGE REPORT. ON (B)(6) 2024, THE PATIENT RETURNED WITH RECURRENT GRADE 4 MR. THE CLIP REMAINED STABLE AND WELL SEATED. A SECOND CLIP INTERVENTION WAS PERFORMED. ONE CLIP WAS PLACED MEDIAL TO THE ORIGINAL XTW. THE MR WAS REDUCED TO GRADE LESS THAN 1. PER THE PHYSICIAN, THE RECURRENT MR WAS DUE TO NEW PATHOLOGY WITH A POSTERIOR LEAFLET FLAIL. THE PHYSICIAN SUGGESTED THAT A NEW FLAIL OF DISEASE PROGRESSION MIGHT HAVE OCCURRED AFTER THE INITIAL PROCEDURE.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 19011669 ↗
• InjuryFeb 12, 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) 2022, THE PATIENT PRESENTED WITH DEGENERATIVE MITRAL REGURGITATION (MR) WITH LEAFLET TETHERING, AND AN ANTERIOR LEAFLET PROLAPSE WITH FLAIL. ONE MITRACLIP (CDS0701-XTW, 10824R180) WAS IMPLANTED, REDUCING THE MR TO GRADE 1+. ON (B)(6) 2023, THE PATIENT WAS HOSPITALIZED WITH DYSPNEA, LOWER EXTREMITY EDEMA, AND ACUTE CONGESTIVE HEART FAILURE WAS DIAGNOSED. FOLLOW-UP WAS PERFORMED WITH CARDIOTHORACIC SURGERY AND PROGRESSIVE, SEVERE MR WITH AN ECCENTRICALLY DIRECTED JET WAS NOTED. MEDICATIONS HAD BEEN PROVIDED AS TREATMENT. REPORTEDLY, THE PATIENT REQUIRED MULTIPLE ROUNDS OF DIURESIS (MEDICATIONS PROVIDED). ON (B)(6) 2023, THE PATIENT WAS HOSPITALIZED WITH RECURRENT MR. DURING THIS HOSPITALIZATION, ON (B)(6) 2023, A MITRAL VALVE REPLACEMENT WAS PERFORMED. SUBSEQUENT TO THE PREVIOUS REPORTS, THE ADDITIONAL INFORMATION WAS RECEIVED: THE MITRACLIP HAD REMAINED STABLE AND WELL SEATED. THERE WAS NO DEVICE RELATED TISSUE INJURY OBSERVED. PER PHYSICIAN, THE RECURRENT MR WAS DEVICE RELATED. PER PHYSICIAN, THE WORSENING HEART FAILURE WAS UNRELATED TO THE DEVICE.

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

  MAUDE report 18683813 ↗
• DeathFeb 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING FILED DUE TO HEART FAILURE AND DEATH. 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 DEGENERATIVE MITRAL REGURGITATION WITH LEAFLET PROLAPSE AND FLAIL. ONE MITRACLIP (CDS0701-XTW, 10423R134) WAS IMPLANTED, REDUCING THE MR TO GRADE 2+. THERE WAS NO DEVICE DEFICIENCY. ON (B)(6) 2021, SEVERE MR WAS NOTED. PER PHYSICIAN, THE MR WAS UNRELATED TO THE MITRACLIP DEVICE. ON (B)(6) 2021, ANOTHER MITRACLIP WAS SUCCESSFULLY IMPLANTED, REDUCING THE MR. THERE WAS NO DEVICE DEFICIENCY WITH EITHER CLIP. ON (B)(6) 2023, THE PATIENT HAD PASSED AWAY WHILE AT HOME. HEART FAILURE WAS NOTED. PER PHYSICIAN, THE EVENT WAS UNKNOWN IF RELATED TO THE INDEX PROCEDURE CLIP. THERE WAS NO DEVICE DEFICIENCY.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 18659146 ↗
• DeathFeb 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS BEING CONSERVATIVELY FILED AS A DEATH. CRD_1002 - EXPAND G4 PHASE 1 AND PHASE 2 STUDY. PATIENT ID:(B)(6). IT WAS REPORTED THAT ON (B)(6) 2021, THE PATENT PRESENTED WITH FUNCTIONAL MITRAL REGURGITATION (MR) WITH A WIDE JET. ONE MITRACLIP (CDS0701-XTW, 10423R136) WAS IMPLANTED, REDUCING THE MR TO GRADE 1+. THERE WAS NO DEVICE DEFICIENCY. ON (B)(6) 2023, THE PATIENT HAD PASSED AWAY. PER PHYSICIAN, THE EVENT WAS UNKNOWN IF DEVICE RELATED, AND ADDITIONAL DETAILS ARE NOT AVAILABLE. THERE WAS NO DEVICE MALFUNCTION. THERE WAS NO DEATH CERTIFICATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18658850 ↗
• InjuryDec 21, 2023Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED THAT ON MARCH 16, 2022, A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 4. TWO MITRACLIP XTWS WERE SUCCESSFULLY IMPLANTED. THE MR WAS REDUCED TO TRACE. ON AN UNKNOWN DATE, THE PATIENT RETURNED SYMPTOMATIC. AN ECHOCARDIOGRAM WAS PERFORMED AND REVEALED RECURRENT MITRAL REGURGITATION (MR) AND THAT THE FIRST PREVIOUSLY IMPLANTED MITRACLIP HAD DETACHED FROM THE POSTERIOR LEAFLET AND REMAINED ATTACHED TO THE ANTERIOR LEAFLET (SINGLE LEAFLET DEVICE ATTACHMENT/SLDA). THE OTHER IMPLANTED CLIP REMAINED STABLE ON BOTH LEAFLETS. ON AN UNKNOWN DATE, TO TREAT THE SLDA, THE PATIENT UNDERWENT A MITRAL VALVE REPLACEMENT SURGERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 18378647 ↗
• InjuryDec 11, 2023Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT ON (B)(6) 2022, A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT A FUNCTIONAL MITRAL REGURGITATION (MR). ONE CLIP WAS IMPLANTED WITH NO REPORTED ISSUE. ON 16NOV2023, THE PATIENT PRESENTED WITH RECURRENT GRADE 4+ MR. THE DECISION WAS MADE TO TREAT THE RECURRENT MR WITH A NON-ABBOTT DEVICE. DURING THE PROCEDURE, IT WAS OBSERVED UNDER X-RAY THAT THE CLIP WAS OPENED TO APPROXIMATELY 90 DEGREES. PER THE PHYSICIAN, AT THE 6-MONTH FOLLOW-UP, THE PATIENT HAD MILD MR, SUGGESTING THAT THE CLIP OPENING WHILE LOCKED (COWL) ISSUE LIKELY OCCURRED SOMETIME AFTER 6-MONTHS POST-IMPLANT. THE PHYSICIAN BELIEVES AN ISSUE WITH THE LOCKING MECHANISM WAS THE CAUSE OF THE CLIP OPENING WHILE LOCKED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 18300351 ↗
• InjuryDec 8, 2023Incomplete 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 4+. XTW CLIP ((B)(6)) WAS IMPLANTED WITH NO REPORTED ISSUE, REDUCING MR TO GRADE 1-2. ON (B)(6) 2023, THE PATIENT WAS PRESENTED WITH RECURRENT MR OF GRADE 4+. THE CLIP WAS OBSERVED TO DETACH FROM THE POSTERIOR LEAFLET (SINGLE LEAFLET DEVICE ATTACHMENT (SLDA)), WHICH WAS BELIEVED TO BE DUE TO WORSENING OF MR. A NEW POSTERIOR LEAFLET FLAIL WAS OBSERVED DUE TO THE SLDA. ADDITIONAL MITRACLIP PROCEDURE WAS PERFORMED TO STABILIZE THE SLDA CLIP AND REDUCE MR. DURING PREPARATION OF XTW CLIP ((B)(6)), THE CLIP ARM WOULD NOT OPEN. AFTER MULTIPLE ATTEMPTS, IT WAS DECIDED NOT TO USE THE CLIP. ANOTHER XTW ((B)(6)) CLIP WAS PREPPED PER INSTRUCTION FOR USE (IFU) AND WAS INSERTED INTO THE STEERABLE GUIDE CATHETER (SGC). AFTER THE CLIP WAS PLACED IN THE LEFT ATRIUM, THE PHYSICIAN DECIDED TO REMOVE THE CDS AND SGC DUE TO LOW TRANSSEPTAL PUNCTURE AND PERFORM ANOTHER TRANSSEPTAL PUNCTURE. WITH THE CLIP BEING REMOVED FROM THE SGC, THE XTW CLIP ((B)(6)) WAS NOT USED AS PER IFU. AFTER SUCCESSFUL TRANSEPTAL ACCESS, ANOTHER XTW CLIP ((B)(6)) WAS OPENED, PREPPED PER IFU AND

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

  MAUDE report 18291431 ↗
• InjuryNov 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON 08 NOV 2022, A PATIENT PRESENTED GRADE 4 FUNCTIONAL MITRAL REGURGITATION (MR) FOR A MITRACLIP INTERVENTION. ONE XTW CLIP WAS IMPLANTED AND THE MR WAS REDUCED TO GRADE 2. ON 31 OCTOBER 2023, THE PATIENT RETURNED FOR A SECOND CLIP INTERVENTION DUE TO RECURRENT GRADE 4 DEGENERATIVE MITRAL REGURGITATION (MR). ONE ADDITIONAL CLIP WAS IMPLANTED AND THE MR WAS REDUCE TO TRACE TO MILD. THE PHYSICIAN DID NOT COMMENT ON WHY THE MR RETURNED, AS THEY DID NOT PERFORM THE FIRST CLIP INTERVENTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 18176834 ↗
• InjuryNov 8, 2023Incomplete Coaptation; Incomplete Coaptation

  IT WAS REPORTED ON (B)(6) 2023, A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) WITH A GRADE OF 4. AN XTW CLIP WAS INSERTED AND DEPLOYED ON THE MITRAL VALVE. MR WAS REDUCED TO 1-2. ON (B)(6) 2023, DUE TO A CAR ACCIDENT, THE PATIENT RETURNED TO THE HOSPITAL. ECHOCARDIOGRAPHY SHOWED THE CLIP HAS DETACHED FROM 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 18097496 ↗
• InjuryNov 6, 2023Entrapment of Device; Incomplete Coaptation; Entrapment of Device; 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 3-4. A MITRACLIP XTW WAS IMPLANTED WITHOUT ISSUES REDUCING MR TO <1. ON (B)(6)2023, THE PATIENT EXPERIENCED CARDIOGENIC SHOCK. AN ECHOCARDIOGRAM WAS PERFORMED WHICH REVEALED RECURRENT MITRAL REGURGITATION (MR) GRADE 4, A LEAFLET TEAR, AND THAT THE CLIP HAD DETACHED FROM THE POSTERIOR MITRAL LEAFLET (PML) RESULTING IN A SINGLE LEAFLET DEVICE ATTACHMENT (SLDA). IMAGING SUGGESTED THERE WAS CHORDAL ENTRAPMENT ON THE ANTERIOR LEAFLET. TO STABILIZE THE SLDA, TWO MITRACLIP XT DEVICES WERE IMPLANTED. THE MR WAS REDUCED TO GRADE 1. WITHIN TWELVE HOURS POST PROCEDURE, THE CARDIOGENIC SHOCK RESOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 18073298 ↗