MITRACLIP CDS0501Recalls & reported problems

Summary

The FDA's MAUDE database contains 312 adverse event reports that list this exact device (DI 08717648216800), received between Oct 28, 2016 and Oct 31, 2022 — classified as 8 deaths, 193 injuries, 111 malfunctions.

The most frequently reported specific device problem is “Incomplete Coaptation” (128 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 312 reports, in the reporter's own words as published by the FDA.

• InjuryOct 31, 2022Migration; Migration

  THIS IS FILED TO REPORT PARTIAL CLIP DETACHMENT AND RECURRENT MITRAL REGURGITATION. IT WAS REPORTED THAT ON (B)(6) 2018, A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH AN UNKNOWN GRADE. TWO CLIPS WERE IMPLANTED, REDUCING MR TO AN UNKNOWN GRADE. ON (B)(6) 2022, THE PATIENT RETURNED TO THE HOSPITAL AND IMAGING SHOWED ONE OF THE IMPLANTED CLIPS HAD PARTIALLY DETACHED FROM THE POSTERIOR LEAFLET, CAUSING MR TO INCREASE TO A GRADE OF 4. THEREFORE, AN ADDITIONAL MITRACLIP WAS PERFORMED, AND ONE CLIP WAS IMPLANTED, REDUCING MR TO A GRADE OF 1.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 15699386 ↗
• InjuryJul 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS FILED FOR ATRIAL SEPTAL DEFECT AND MITRAL STENOSIS. IT WAS REPORTED THAT THE MITRACLIP PROCEDURE WAS PERFORMED ON (B)(6) 2017. FOUR MITRACLIPS WERE IMPLANTED TO TREAT THE MITRAL REGURGITATION (MR), REDUCING THE MR FROM GRADE 4+ TO GRADE 3+. AT THE 30 DAY FOLLOW UP, THE MEAN PRESSURE GRADIENT WAS 5.3 MMHG. ON AN UNSPECIFIED DATE, IT WAS NOTED THAT THE PATIENT HAD MITRAL STENOSIS AND A SEVERE ATRIAL SEPTAL DEFECT (ASD), RESULTING IN LEFT TO RIGHT SHUNTING AND RIGHT SIDED HEART FAILURE. ON (B)(6) 2022, TRANSESOPHAGEAL ECHOCARDIOGRAM WAS PERFORMED. THE MEAN PRESSURE GRADIENT WAS 8-13 MMHG; HOWEVER, MR WAS GRADE 0. ALL CLIPS WERE NOTED TO BE WELL ATTACHED TO BOTH LEAFLETS AND FUNCTIONING AS EXPECTED. NO ADDITIONAL INTERVENTION WAS PERFORMED OR IS PLANNED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Heart Failure/Congestive Heart Failure; Mitral Valve Stenosis; Perforation

  MAUDE report 15048835 ↗
• InjuryOct 5, 2021Incomplete Coaptation; Incomplete Coaptation

  THIS IS BEING FILED TO REPORT THE CLIP DETACHING FROM ONE LEAFLET AND INCREASED MR REQUIRING INTERVENTION. IT WAS REPORTED THAT THE INITIAL MITRACLIP PROCEDURE WAS PERFORMED IN 2018 AND 2019, TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR). THREE CLIPS WERE IMPLANTED. THE PATIENT RETURNED ON A LATER DATE WITH THE MR INCREASED TO 4+. IT WAS NOTED THE NT CLIP IMPLANTED ON THE MEDIAL SIDE OF A2P2 HAD DETACHED FROM THE POSTERIOR LEAFLET (SINGLE LEAFLET DEVICE ATTACHMENT (SLDA)). THE OTHER TWO PREVIOUSLY IMPLANTED CLIPS REMAINED STABLE ON THE LEAFLETS. A SECOND PROCEDURE WAS PERFORMED ON (B)(6) 2021. TWO CLIPS WERE IMPLANTED TO STABILIZE THE SLDA CLIP, REDUCING MR TO 1-2. PER THE PHYSICIAN, IT APPEARED THE SLDA CLIP HAD GRASPED CHORDS WHEN IMPLANTED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 12578770 ↗
• InjuryAug 13, 2021Incomplete Coaptation; Incomplete Coaptation

  SUBSEQUENT TO THE INITIAL REPORT FILING, ADDITIONAL INFORMATION RECEIVED REPORTING THAT ON (B)(6) 2021 A SECOND MITRACLIP PROCEDURE WAS PERFORMED. TWO ADDITIONAL CLIPS WERE IMPLANTED TO STABILIZE THE SLDA, REDUCING MR FROM 4+ TO 2. THERE WERE NO ISSUES DURING THE PROCEDURE. THE DEVICES PERFORMED AS INTENDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

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

  MAUDE report 12320728 ↗
• InjuryApr 14, 2021Incomplete Coaptation; Incomplete Coaptation

  THIS IS FILED TO REPORT SINGLE LEAFLET DEVICE ATTACHMENT/SLDA, PROLONGED HOSPITALIZATION, RECURRENT MITRAL REGURGITATION, AND MEDICAL INTERVENTION IT WAS REPORTED THAT THIS WAS A MITRACLIP PROCEDURE TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH AN MR GRADE OF 4. IT WAS NOTED THAT THE LEAFLETS WERE FRIABLE. ON 03/12/2018, THREE CLIPS WERE DEPLOYED. HOWEVER, TWO CLIPS (80102U218, 71211U267) BECAME DETACHED FROM THE POSTERIOR LEAFLET, BUT REMAINED ATTACHED TO THE ANTERIOR LEAFLET (SINGLE LEAFLET DEVICE ATTACHMENT/SLDA). THE OTHER CLIP REMAINS STABLE ON BOTH LEAFLETS. ADDITIONAL TREATMENT WAS NOT PERFORMED. THREE CLIPS WERE IMPLANTED, REDUCING MR TO 3. THEN ON 03/24/2021, IT WAS REPORTED THAT THIS WAS A SECOND MITRACLIP PROCEDURE TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH AN MR GRADE OF 4. THE PATIENT PRESENTED WITH DYSPNEA AND ANGINA. THE CLIP DELIVERY SYSTEM (CDS) WAS ADVANCED TO THE MITRAL VALVE, AND ONE CLIP WAS DEPLOYED. HOWEVER, THE CLIP BECAME DETACHED FROM THE ANTERIOR LEAFLET, BUT REMAINED ATTACHED TO THE POSTERIOR LEAFLET (SINGLE LEAFLET DEVICE ATTACHMENT/SLDA). TISSUE DAMAGE WAS SUSPECTED. THE PHYSICIAN STATED THE CAUSE OF THE SLDA WAS DUE TO FRIABLE LEAFLET

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

  MAUDE report 11666310 ↗
• InjuryApr 14, 2021Incomplete Coaptation; Incomplete Coaptation

  THIS IS FILED TO REPORT SINGLE LEAFLET DEVICE ATTACHMENT/SLDA, PROLONGED HOSPITALIZATION, RECURRENT MITRAL REGURGITATION, AND MEDICAL INTERVENTION. IT WAS REPORTED THAT THIS WAS A MITRACLIP PROCEDURE TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH AN MR GRADE OF 4. IT WAS NOTED THAT THE LEAFLETS WERE FRIABLE. ON 03/12/2018, THREE CLIPS WERE DEPLOYED. HOWEVER, TWO CLIPS (80102U218, 71211U267) BECAME DETACHED FROM THE POSTERIOR LEAFLET, BUT REMAINED ATTACHED TO THE ANTERIOR LEAFLET (SINGLE LEAFLET DEVICE ATTACHMENT/SLDA). THE OTHER CLIP REMAINS STABLE ON BOTH LEAFLETS. ADDITIONAL TREATMENT WAS NOT PERFORMED. THREE CLIPS WERE IMPLANTED, REDUCING MR TO 3. THEN ON (B)(6) 2021, IT WAS REPORTED THAT THIS WAS A SECOND MITRACLIP PROCEDURE TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH AN MR GRADE OF 4. THE PATIENT PRESENTED WITH DYSPNEA AND ANGINA. THE CLIP DELIVERY SYSTEM (CDS) WAS ADVANCED TO THE MITRAL VALVE, AND ONE CLIP WAS DEPLOYED. HOWEVER, THE CLIP BECAME DETACHED FROM THE ANTERIOR LEAFLET, BUT REMAINED ATTACHED TO THE POSTERIOR LEAFLET (SINGLE LEAFLET DEVICE ATTACHMENT/SLDA). TISSUE DAMAGE WAS SUSPECTED. THE PHYSICIAN STATED THE CAUSE OF THE SLDA WAS DUE TO FRIABLE LEAFL

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

  MAUDE report 11666228 ↗
• InjuryFeb 11, 2021Off-Label Use; Incomplete Coaptation; Off-Label Use; Incomplete Coaptation

  THIS IS FILED TO REPORT SINGLE LEAFLET DEVICE ATTACHMENT IT WAS REPORTED THAT ON (B)(6) 2017, A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT MITRAL REGURGITATION (MR) WITH A GRADE OF 4 AND TRICUSPID REGURGITATION (TR) WITH AN UNKNOWN GRADE. ONE NT CLIP WAS SUCCESSFULLY IMPLANTED IN THE MITRAL VALVE REDUCING MR TO A GRADE OF 1. ALSO, ONE NT CLIP WAS SUCCESSFULLY IMPLANTED IN THE TRICUSPID VALVE, REDUCING TR TO AN UNKNOWN GRADE. ON AN UNKNOWN DATE, THE PATIENT RETURNED TO THE HOSPITAL SYMPTOMATIC. ECHOCARDIOGRAPHY WAS PERFORMED AND SHOWED THAT BOTH MR AND TR HAD INCREASED. IT WAS ALSO NOTICED THAT THE CLIP IN THE TRICUSPID VALVE HAD DETACHED FROM ONE OF THE LEAFLETS AND REMAINED ATTACHED TO THE SEPTAL LEAFLET (SINGLE LEAFLET DEVICE ATTACHMENT/SLDA). THE CLIP IN THE MITRAL VALVE REMAINED ATTACHED TO THE LEAFLETS. HOWEVER, THE PHYSICIAN DID NOT KNOW WHAT CAUSED THE INCREASED IN MR. ON (B)(6) 2021, A SECOND PROCEDURE WAS PERFORMED TO TREAT THE INCREASED MR AND TR. IN THE MITRAL VALVE, VALVE REPLACEMENT WAS PERFORMED. IN THE TRICUSPID VALVE, AN ADDITIONAL CLIP WAS IMPLANTED TO STABILIZE THE SLDA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Tricuspid Regurgitation

  MAUDE report 11314102 ↗
• InjuryFeb 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS FILED TO REPORT MITRAL REGURGITATION IT WAS REPORTED THAT ON (B)(6) 2017, A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT MITRAL REGURGITATION (MR) WITH A GRADE OF 4 AND TRICUSPID REGURGITATION (TR) WITH AN UNKNOWN GRADE. ONE NT CLIP WAS SUCCESSFULLY IMPLANTED IN THE MITRAL VALVE REDUCING MR TO A GRADE OF 1. ALSO, ONE NT CLIP WAS SUCCESSFULLY IMPLANTED IN THE TRICUSPID VALVE, REDUCING TR TO AN UNKNOWN GRADE. ON AN UNKNOWN DATE, THE PATIENT RETURNED TO THE HOSPITAL SYMPTOMATIC. ECHOCARDIOGRAPHY WAS PERFORMED AND SHOWED THAT BOTH MR AND TR HAD INCREASED. IT WAS ALSO NOTICED THAT THE CLIP IN THE TRICUSPID VALVE HAD DETACHED FROM ONE OF THE LEAFLETS AND REMAINED ATTACHED TO THE SEPTAL LEAFLET (SINGLE LEAFLET DEVICE ATTACHMENT/SLDA). THE CLIP IN THE MITRAL VALVE REMAINED ATTACHED TO THE LEAFLETS. HOWEVER, THE PHYSICIAN DID NOT KNOW WHAT CAUSED THE INCREASED IN MR. ON (B)(6) 2021, A SECOND PROCEDURE WAS PERFORMED TO TREAT THE INCREASED MR AND TR. IN THE MITRAL VALVE, VALVE REPLACEMENT WAS PERFORMED. IN THE TRICUSPID VALVE, AN ADDITIONAL CLIP WAS IMPLANTED TO STABILIZE THE SLDA. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Mitral Regurgitation

  MAUDE report 11314001 ↗
• MalfunctionDec 29, 2020Device Damaged by Another Device; Migration; Device Damaged by Another Device; Migration

  THIS WILL BE FILED TO REPORT THE CLIP BECAME DAMAGED BY ANOTHER CLIP AND CAUSED CLIP MOVEMENT. IT WAS REPORTED THAT THE INDEX MITRACLIP PROCEDURE WAS PERFORMED ON (B)(6) 2017 TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH GRADE 4. TWO CLIPS (CDS0501, 70403U185 AND CDS0501, 70403U184) IMPLANTED, REDUCING MR TO 1. OVERTIME, THE DISEASE PROGRESSED, AND MR INCREASED TO 4. THE CLIPS REMAINED STABLE ON BOTH LEAFLETS WITH NO ISSUES. ON (B)(6) 2020, A SECOND PROCEDURE WAS PERFORMED. THE FIRST CLIP (00718U12) WAS IMPLANTED MEDIAL SIDE OF ONE OF THE CLIPS IMPLANTED IN 2017 WITH NO ISSUES. A SECOND CLIP (00325U153) WAS PLACED ON THE LATERAL SIDE OF THE OTHER CLIP IMPLANTED IN 2017. THE CLIP ROTATED COUNTER CLOCKWISE AS IT CROSSED INTO THE LEFT VENTRICLE AND GOT TANGLED IN THE CHORDAE WITH THE CLIP IMPLANTED IN 2017. AFTER SEVERAL TRIES, THE CLIP WAS FREED FROM THE CHORDAE AND THE CLIP, BUT UNDER FLUOROSCOPY, THE CLIP IMPLANTED IN 2017 APPEARED TO BE LOOSE OR MORE MOBILE. THE CLIP WAS RETRACTED BACK INTO THE ATRIUM AND REPOSITIONED NEXT TO THE MOBILE CLIP AND STABILIZED THE CLIP. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11090084 ↗
• InjuryDec 7, 2020Incomplete Coaptation; Incomplete Coaptation

  THIS IS FILED TO REPORT SINGLE LEAFLET DEVICE ATTACHMENT/SLDA, PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT THIS WAS A MITRACLIP PROCEDURE TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR). ON (B)(6) 2017, ONE CLIP WAS SUCCESSFULLY DEPLOYED, REDUCING MR. THEN ON AN UNKNOWN DATE, THE PATIENT RETURNED FEELING TIRED. THEREFORE, THE PHYSICIAN ORDERED ANOTHER ECHOCARDIOGRAM. IT WAS DISCOVERED THAT THE CLIP BECAME DETACHED FROM THE POSTERIOR LEAFLET, BUT REMAINED ATTACHED TO THE ANTERIOR LEAFLET (SINGLE LEAFLET DEVICE ATTACHMENT/SLDA). THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Fatigue

  MAUDE report 10961216 ↗
• InjuryOct 21, 2020Incomplete Coaptation; Incomplete Coaptation

  THIS IS FILED TO REPORT THE SUSPECTED LEAFLET TEAR AND SINGLE LEAFLET DEVICE ATTACHMENT/SLDA. IT WAS REPORTED THAT THE INITIAL MITRACLIP PROCEDURE WAS PERFORMED ON (B)(6) 2018 TO TREAT GRADE 4 DEGENERATIVE MITRAL REGURGITATION (MR). TWO CLIPS WERE IMPLANTED, REDUCING MR TO GRADE 1. ON (B)(6) 2020, THE PATIENT RETURNED FOR A FOLLOW UP VISIT AND ECHOCARDIOGRAM WAS PERFORMED. MR INCREASED TO 4. IT WAS SUSPECTED THAT THERE WAS A MINOR LEAFLET TEAR AND ONE OF THE CLIPS DETACHED FROM THE ANTERIOR LEAFLET AND REMAINED ATTACHED TO THE POSTERIOR LEAFLET (SLDA). PART OF THE CLIP HAD ALREADY ENDOTHELIALIZED; THEREFORE, IT COULD NOT BE CONFIRMED IF THE RECURRENT MR AND LEAFLET TEAR WERE DUE TO DISEASE PROGRESSION OR DUE TO THE SUSPECTED LEAFLET TEAR AND SLDA. A SECOND MITRACLIP PROCEDURE WAS ATTEMPTED ON (B)(6) 2020; HOWEVER, DURING PLACEMENT OF THE CLIP, THE GRADIENT INCREASED UP TO 7MMHG AND MR REDUCTION WAS MINOR; THEREFORE, THE CLIP WAS NOT IMPLANTED AND THE GRADIENT RETURNED TO 4MMHG. THE PROCEDURE WAS DISCONTINUED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Mitral Regurgitation; Tissue Damage

  MAUDE report 10712359 ↗
• InjuryOct 1, 2020Incomplete Coaptation; Incomplete Coaptation

  THIS IS FILED TO REPORT THE SINGLE LEAFLET DEVICE ATTACHMENT (SLDA). IT WAS REPORTED THAT THE MITRACLIP PROCEDURE WAS PERFORMED ON AN UNSPECIFIED DATE, APPROXIMATELY 2 YEARS AGO, TO TREAT GRADE 4 DEGENERATIVE MITRAL REGURGITATION (MR). ONE CLIP WAS IMPLANTED, REDUCING MR TO GRADE 2. THE PROCEDURE WAS SUCCESSFUL, AND THE PATIENT HAD A GOOD OUTCOME. IN (B)(6) 2020, ECHOCARDIOGRAM WAS PERFORMED. THE CLIP DETACHED FROM THE POSTERIOR LEAFLET AND REMAINED ATTACHED TO THE ANTERIOR LEAFLET, (SLDA) AND MR INCREASED TO 4. THE PATIENT REMAINS ASYMPTOMATIC AND IS PENDING ANOTHER EVALUATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Mitral Regurgitation

  MAUDE report 10617665 ↗
• InjuryApr 28, 2020Migration; Migration

  THIS IS FILED TO REPORT POST PROCEDURE CLIP MOVEMENT WITH RECURRENT MITRAL REGURGITATION. IT WAS REPORTED THAT THE INDEX MITRACLIP PROCEDURE WAS PERFORMED ON (B)(6) 2018 TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH GRADE 4+. ONE CLIP WAS IMPLANTED SUCCESSFULLY, REDUCING MR TO <1. THE PROCEDURE WAS COMPLETED WITH GREAT RESULTS. ON UNSPECIFIED DATE, THE PATIENT PRESENTED WITH RECURRENT MR GRADE OF 4+. ON (B)(6) 2020, A CONTROL ECHOCARDIOGRAM WAS PERFORMED WHICH FOUND THAT A LARGE JET WAS COMING THROUGH THE IMPLANTED CLIP. THE CLIP HAD CHANGED POSITION DISTORTING THE VALVE POSSIBLY DUE TO THE PROGRESSION OF THE DISEASE. THERE WAS NO TISSUE DAMAGE NOTED AND THE CLIP WAS NOTED TO BE STABLE ON THE LEAFLETS. A SECOND MITRACLIP PROCEDURE WAS DISCUSSED; HOWEVER, ANATOMICALLY IT WAS NOT AN OPTION DUE TO THE DISTORTION OF THE VALVE. MITRAL VALVE REPLACEMENT IS BEING CONSIDERED FOR A LATER DATE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Mitral Regurgitation

  MAUDE report 10005754 ↗
• InjuryMar 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS FILED TO REPORT POST MITRACLIP PROCEDURE, THE PATIENT RETURNED WITH INCREASED MR, AND LEAFLET TEAR REQUIRING MEDICAL INTERVENTION. IT WAS REPORTED THAT THE INDEX MITRACLIP PROCEDURE WAS PERFORMED ON 04/27/2018 TO TREAT MITRAL REGURGITATION WITH GRADE 4. TWO CLIPS (80224U114, 80224U115) WERE IMPLANTED REDUCING MR TO 1. ON (B)(6) 2020, THE PATIENT RETURNED WITH SIGNIFICANT MR INCREASE OF GRADE 4 AND A LEAFLET TEAR WAS NOTED. A CLIP (91204U114) WAS IMPLANTED, BUT GRADIENT WENT UP TO 6 MMHG AND MR WAS NOT REDUCED. TWO VASCULAR PLUGS WERE USED TO SUCCESSFULLY COMPLETE THE PROCEDURE, REDUCING MR TO 2. THE PATIENT IS FINE AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Mitral Regurgitation; Tissue Damage

  MAUDE report 9872060 ↗
• InjuryFeb 26, 2020Migration; Migration

  THIS IS FILED TO REPORT PARTIAL CLIP MOVEMENT IT WAS REPORTED THAT THE FIRST MITRACLIP PROCEDURE WAS PERFORMED ON (B)(6) 2017 TO TREAT GRADE 4 DEGENERATIVE MITRAL REGURGITATION (MR). TWO CLIPS WERE IMPLANTED SUCCESSFULLY REDUCING MR TO 1. ON (B)(6) 2020, ECHOCARDIOGRAM WAS PERFORMED, IT WAS OBSERVED THAT ONE OF THE CLIPS HAD PARTIALLY MOVED AND MR INCREASED TO 4. THERE WAS NO LEAFLET INJURY. A SECOND PROCEDURE WAS PERFORMED ON (B)(6) 2020, THREE XTR CLIPS WERE IMPLANTED WITHOUT ISSUES, REDUCING MR TO 1+. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Mitral Regurgitation

  MAUDE report 9758364 ↗
• InjuryJan 22, 2020Incomplete Coaptation; Incomplete Coaptation

  THIS IS FILED TO REPORT THE SINGLE LEAFLET DEVICE ATTACHMENT/SLDA. IT WAS REPORTED THE MITRACLIP PROCEDURE WAS PERFORMED ON (B)(6) 2018 TO TREAT MIXED MITRAL REGURGITATION (MR). TWO CLIPS (71011U144, 71011U130) WERE IMPLANTED, REDUCING MR FROM 4 TO <1. APPROXIMATELY 18 MONTHS LATER, THE PATIENT EXPERIENCED DYSPNEA. ECHOCARDIOGRAM WAS PERFORMED, ONE OF THE IMPLANTED CLIPS HAD DETACHED FROM THE ANTERIOR LEAFLET AND REMAINED ATTACHED TO THE POSTERIOR LEAFLET, (SINGLE LEAFLET DEVICE ATTACHMENT/SLDA) AND MR INCREASED TO 4+. NO ADDITIONAL PROCEDURES HAVE BEEN PLANNED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Dyspnea; Mitral Regurgitation

  MAUDE report 9618567 ↗
• InjuryDec 13, 2019Incomplete Coaptation; Incomplete Coaptation

  THIS IS FILED TO REPORT A SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) AND RECURRENT MITRAL REGURGITATION (MR). IT WAS REPORTED THAT ON (B)(6) 2016, A MITRACLIP PROCEDURE WAS PERFORMED TO DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 4+. TWO MITRACLIP¿S (B)(4) WERE IMPLANTED, REDUCING MR TO A GRADE OF 1+. ON (B)(6) 2019, ECHOCARDIOGRAM WAS PERFORMED AND SHOWED THAT MR HAD INCREASED TO A GRADE OF 4+. IT WAS SUSPECTED THAT ONE OF THE CLIPS HAD DETACHED FROM ONE OF THE LEAFLETS (SINGLE LEAFLET DEVICE ATTACHMENT/SLDA). ON (B)(6) 2019, A SECOND MITRACLIP PROCEDURE WAS PERFORMED TO REDUCE MR WITH A GRADE OF 4+. IT WAS CONFIRMED THAT AN SLDA OCCURRED AND THE LATERAL OF THE TWO IMPLANTED CLIPS HAD DETACHED FROM THE POSTERIOR LEAFLET AND REMAINED ATTACHED TO THE ANTERIOR LEAFLET. THEREFORE, TO STABILIZE THE SLDA, AN ADDITIONAL CLIP WAS IMPLANTED LATERALLY, REDUCING MR TO A GRADE OF 1+. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Mitral Regurgitation

  MAUDE report 9467232 ↗
• InjuryDec 6, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THIS IS BEING FILED TO REPORT THE FOREIGN MATERIAL AND CLOTS. IT WAS REPORTED THAT THIS WAS A MITRACLIP PROCEDURE TO TREAT MIXED MITRAL REGURGITATION (MR) WITH A GRADE OF 3-4. THE CLIP DELIVERY SYSTEM (CDS) WAS ADVANCED INTO THE PATIENT ANATOMY WHEN AN OBJECT WAS NOTED ON THE CLIP ARMS AND THROMBUS WAS SUSPECTED. THE CDS WAS REMOVED AND IT WAS NOTED THE CLIP ARMS WERE ENTANGLED WITH A SILK LIKE OBJECT WITH SOME CLOTS. THE OBJECT WAS RINSED AND THE PHYSICIAN TRIED TO BREAK IT BUT WAS UNSUCCESSFUL. THE OBJECT WAS SENT TO TESTING WITHIN THE HOSPITAL. THE PROCEDURE WAS CONTINUED WITH THE ONE CLIP IMPLANTED, REDUCING MR TO 1+. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Thrombosis

  MAUDE report 9429133 ↗
• InjuryNov 14, 2019Incomplete Coaptation; Incomplete Coaptation

  THIS IS FILED FOR SINGLE LEAFLET DEVICE ATTACHMENT. IT WAS REPORTED THAT THE INITIAL MITRACLIP PROCEDURE WAS PERFORMED ON (B)(6) 2018, TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 4. ONE CLIP WAS IMPLANTED, REDUCING MR TO 1. IMAGING WAS REPORTEDLY DIFFICULT. THE CLIP REMAINED STABLE ON BOTH LEAFLETS. AT THE 30-DAY FOLLOWUP, THE PATIENT PRESENT WITH UNSPECIFIED SYMPTOMS. THE CLIP STILL REMAINED STABLE ON BOTH LEAFLETS. HOWEVER, THE PATIENT PRESENTED WITH SYMPTOMS AGAIN 3-6 MONTHS LATER BUT THE PATIENT DID NOT WANT TO UNDERGO A SECOND PROCEDURE AT THE TIME. ON AN UNKNOWN DATE, A SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) WAS NOTED. THE CLIP DETACHED FROM THE POSTERIOR LEAFLET AND REMAINED ATTACHED TO THE ANTERIOR LEAFLET. THE MR INCREASED TO 4. ON (B)(6) 2019, THE PATIENT UNDERWENT A SECOND MITRACLIP PROCEDURE TO STABILIZE THE SLDA. ONE CLIP WAS IMPLANTED, REDUCING MR TO 1. IT WAS REPORTED THAT IMAGING WAS DIFFICULT. THE PATIENT IS STABLE AND DOING WELL. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Mitral Regurgitation

  MAUDE report 9323023 ↗
• InjuryOct 11, 2019Incomplete Coaptation; Incomplete Coaptation

  THIS IS BEING FILED TO REPORT THE SINGLE LEAFLET DEVICE ATTACHMENT (SLDA), TISSUE DAMAGE AND RECURRENT MR. IT WAS REPORTED THAT THE INITIAL MITRACLIP PROCEDURE WAS PERFORMED ON (B)(6) 2017 TREAT MITRAL REGURGITATION (MR) WITH A GRADE OF 4. ONE CLIP (CDS0501, 70914U131) WAS IMPLANTED, REDUCING THE MR TO <1. ON (B)(6) 2019, THE PATIENT PRESENTED WITH DYSPNEA. A CONTROL ECHOCARDIOGRAM WAS PERFORMED, WHICH FOUND THAT THE MOST LATERAL CLIP DETACHED FROM THE POSTERIOR LEAFLET AND REMAINED ATTACHED TO THE ANTERIOR LEAFLET (SINGLE LEAFLET DEVICE ATTACHMENT/SLDA). A RUPTURE CHORD WAS NOTED CAUSING SEVERE MR. THERE WAS NOTABLE LEAFLET THICKENING AND CALCIFICATION THROUGHOUT HIS HEART. THERE WAS NO TREATMENT PERFORMED OR PLANNED FOR THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Dyspnea; Mitral Regurgitation; Tissue Damage

  MAUDE report 9181226 ↗
• InjurySep 27, 2019Positioning Failure; Difficult to Remove; Positioning Failure; Difficult to Remove

  THIS IS FILED TO REPORT CLIP DIFFICULT REMOVAL AND TISSUE DAMAGE. IT WAS REPORTED THAT THIS WAS A MITRACLIP PROCEDURE TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 4. THE FIRST TWO CLIPS WERE IMPLANTED SUCCESSFULLY. TO FURTHER REDUCE MR A THIRD CLIP WAS ADVANCED, THE CLIP GOT CAUGHT ON CHORDAE. THE CLIP WAS FREED; HOWEVER, A CHORDAE RUPTURE OCCURRED, AND MR RETURNED TO 4. GRASPING ATTEMPTS WERE MADE, THERE WAS LOSS OF LEAFLET CAPTURE, THE ANTERIOR LEAFLET WOULD NOT STAY CAPTURED. THE CLIP WAS NOT IMPLANTED AND WAS REMOVED WITHOUT FURTHER ISSUE. NO ADDITIONAL TREATMENT IS PLANNED FOR THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Mitral Regurgitation; Tissue Damage

  MAUDE report 9132066 ↗
• InjurySep 10, 2019Incomplete Coaptation; Incomplete Coaptation

  THIS IS FILED FOR SINGLE LEAFLET DEVICE. IT WAS REPORTED THAT THE INITIAL MITRACLIP PROCEDURE WAS PERFORMED ON (B)(6) 2017, TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 4. TWO MITRACLIPS WERE IMPLANTED, REDUCING MR TO 1. ON AN UNKNOWN DATE, A SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) WAS NOTED. THE CLIP DETACHED FROM THE POSTERIOR LEAFLET AND REMAINED ATTACHED TO THE ANTERIOR LEAFLET. ON (B)(6) 2019, A SECOND MITRACLIP PROCEDURE WAS PERFORMED TO STABILIZE THE SLDA. PRIOR TO GRASPING, A POSTERIOR PROLAPSE WAS NOTED. ONE CLIP WAS IMPLANTED, REDUCING MR FROM 4 TO 1. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Mitral Regurgitation

  MAUDE report 8983308 ↗
• DeathAug 28, 2019Incomplete Coaptation; Incomplete Coaptation

  SUBSEQUENT TO THE INITIAL 30-DAY MEDWATCH REPORT, THE FOLLOWING INFORMATION WAS PROVIDED: MITRAL VALVE REPLACEMENT WAS PERFORMED ON (B)(6) 2019. THE PATIENT DIED ON (B)(6) 2019.

  Patient problems: Dyspnea; High Blood Pressure/ Hypertension; Mitral Regurgitation; Tissue Damage

  MAUDE report 8942399 ↗
• InjuryJul 17, 2019Entrapment of Device; Off-Label Use; Improper or Incorrect Procedure or Method; Unintended Movement; Entrapment of Device; Off-Label Use; Improper or Incorrect Procedure or Method; Unintended Movement

  THIS IS FILED FOR CLIP ENTRAPMENT IN TISSUE AND COULD NOT BE REMOVED, CAUSING TISSUE DAMAGE (CDS0501/90416U110). IT WAS REPORTED THAT THIS WAS A MITRACLIP PROCEDURE TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) WITH A GRADE OF 4. A MITRACLIP WAS ADVANCED AND IMPLANTED IN THE MITRAL VALVE, SUCCESSFULLY REDUCING MR TO 1. THE PROCEDURE CONTINUED TO TREAT TRICUSPID REGURGITATION (TR) WITH A GRADE OF 4. A MITRACLIP (CDS0501 LOT 90416U111) WAS ADVANCED AND DEPLOYED, REDUCING TR TO 1. HOWEVER, ON FLUOROSCOPY THE CLIP LOOKED UNSTABLE AND GRASPED ONLY 4MM OF THE ANTERIOR LEAFLET AND 6MM OF THE SEPTAL LEAFLET. AFTER DEPLOYMENT BOTH LEAFLETS WERE FULLY CAPTURED, HOWEVER MOVEMENT OF THE CLIP WAS TOO ERRATIC. IT WAS DECIDED TO IMPLANT A SECOND CLIP TO STABILIZE THIS CLIP. VISUALIZATION DURING THE INTRODUCTION OF THE CDS WAS DIFFICULT DUE TO THE POSITION OF THE VALVE. A MITRACLIP (CDS0501 LOT 90416U110) WAS ADVANCED WITH A 90 DEGREE MISS-KEY TO THE STEERABLE GUIDE CATHETER (SGC). THE CLIP WAS UNABLE TO MOVE AS EXPECTED AND IT WAS DECIDED TO RETRY WITH A MISS-KEY OF 180 DEGREES. THE CLIP DELIVERY SYSTEM (CDS) HAD A BETTER RESPONSE TO 180 DEGREE MIS-KEY, HOWEVER IT WAS DIFFICULT TO MOVE. THE CDS W

  Patient problems: Tissue Damage

  MAUDE report 8800888 ↗
• InjuryJul 17, 2019Off-Label Use; Migration; Off-Label Use; Migration

  THIS IS FILED FOR PARTIAL CLIP MOVEMENT AFTER DEPLOYMENT (CDS0501/90416U111). IT WAS REPORTED THAT THIS WAS A MITRACLIP PROCEDURE TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) WITH A GRADE OF 4. A MITRACLIP WAS ADVANCED AND IMPLANTED IN THE MITRAL VALVE, SUCCESSFULLY REDUCING MR TO 1. THE PROCEDURE CONTINUED TO TREAT TRICUSPID REGURGITATION (TR) WITH A GRADE OF 4. A MITRACLIP (CDS0501 LOT 90416U111) WAS ADVANCED AND DEPLOYED, REDUCING TR TO 1. HOWEVER, ON FLUOROSCOPY THE CLIP LOOKED UNSTABLE AND GRASPED ONLY 4MM OF THE ANTERIOR LEAFLET AND 6MM OF THE SEPTAL LEAFLET. AFTER DEPLOYMENT BOTH LEAFLETS WERE FULLY CAPTURED, HOWEVER MOVEMENT OF THE CLIP WAS TOO ERRATIC. IT WAS DECIDED TO IMPLANT A SECOND CLIP TO STABILIZE THIS CLIP. VISUALIZATION DURING THE INTRODUCTION OF THE CDS WAS DIFFICULT DUE TO THE POSITION OF THE VALVE. A MITRACLIP (CDS0501 LOT 90416U110) WAS ADVANCED WITH A 90 DEGREE MISS-KEY TO THE STEERABLE GUIDE CATHETER (SGC). THE CLIP WAS UNABLE TO MOVE AS EXPECTED AND IT WAS DECIDED TO RETRY WITH A MISS-KEY OF 180 DEGREES. THE CLIP DELIVERY SYSTEM (CDS) HAD A BETTER RESPONSE TO 180 DEGREE MIS-KEY, HOWEVER IT WAS DIFFICULT TO MOVE. THE CDS WAS RETRACTED, HOWEVER THE TIP OF TH

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8800869 ↗