MITRACLIP CDS0201Recalls & reported problems

Summary

The FDA's MAUDE database contains 82 adverse event reports that list this exact device (DI 08717648195914), received between Aug 4, 2016 and Jan 5, 2022 — classified as 7 deaths, 47 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Incomplete Coaptation” (32 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 82 reports, in the reporter's own words as published by the FDA.

• InjuryJan 5, 2022Incomplete Coaptation; Incomplete Coaptation

  THIS IS FILED TO REPORT THE SINGLE LEAFLET DEVICE ATTACHMENT/SLDA. IT WAS REPORTED THAT THE INITIAL MITRACLIP PROCEDURE WAS PERFORMED ON (B)(6) 2016 (DATE NOT PROVIDED) TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR). TWO CLIPS WERE IMPLANTED, REDUCING MR. ON AN UNSPECIFIED DATE, ECHOCARDIOGRAM WAS PERFORMED, IMAGING SHOWED ONE OF THE CLIPS HAD DETACHED FROM THE ANTERIOR LEAFLET AND REMAINED ATTACHED TO THE POSTERIOR LEAFLET (SLDA) AND MR INCREASED TO 4. ON (B)(6) 2021, A SECOND MITRACLIP PROCEDURE WAS PERFORMED. ONE CLIP WAS IMPLANTED STABILIZING THE SLDA CLIP AND REDUCING MR TO 1. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 13172672 ↗
• InjuryJan 25, 2021Incomplete Coaptation; Incomplete Coaptation

  THIS IS FILED TO REPORT SLDA, INCREASED MR. IT WAS REPORTED THAT ON (B)(6) 2015, THE PATIENT WAS TREATED FOR MIXED MITRAL REGURGITATION (MMR) WITH 2 MITRACLIP DEVICES AND MR WAS REDUCED TO 3+. ON (B)(6) 2021, THE PATIENT HAD A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) AS THE PATIENT WAS EXPERIENCING MR WITH A GRADE OF 4+. IT WAS FOUND THAT ONE CLIP HAD A SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) FROM THE LATERAL A2P2 LEAFLET. THE CLIP WAS STABLE AS THERE WAS ANOTHER IMPLANTED RIGHT NEXT TO IT DURING THE INDEX PROCEDURE. NO ADDITIONAL PROCEDURE HAS BEEN PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Mitral Regurgitation

  MAUDE report 11227124 ↗
• InjuryMar 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS EVENT WAS CAPTURED BASED ON A REVIEW OF THE ARTICLE, PERCUTANEOUS EDGE TO EDGE MITRAL VALVE REPAIR WITH THE MITRACLIP SYSTEM IN BARLOWS DISEASE. IT WAS REPORTED THAT A (B)(6)-YEAR-OLD MALE PATIENT WITH BARLOW¿S DISEASE UNDERWENT A MITRACLIP PROCEDURE TO TREAT DEGENERATIVE MITRAL REGURGITATION WITH GRADE 4. ONE CLIP WAS IMPLANTED REDUCING MR TO 2. ON 30 DAY AND 12 MONTHS FOLLOW UP, THE DEVICE AND PROCEDURE WERE A SUCCESS. ON LAST FOLLOW UP (60 MONTH) VISIT, THE PATIENT HAD RECURRENT MR WHICH WAS TREATED WITH A SECOND MITRACLIP PROCEDURE. TWO ADDITIONAL CLIPS WERE IMPLANTED. HOWEVER, DESPITE THE IMPLANTATION OF ANOTHER TWO CLIPS (THREE CLIPS IN TOTAL) EARLY RECURRENCE OF MR OCCURRED DUE TO THE LEAFLET PERFORATION AND THE PATIENT UNDERWENT URGENT MITRAL VALVE REPLACEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Mitral Regurgitation; Tissue Damage

  MAUDE report 9878175 ↗
• 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 HAD RECURRENT MITRAL REGURGITATION. THIS EVENT WAS CAPTURED BASED ON A REVIEW OF THE ARTICLE, PERCUTANEOUS EDGE TO EDGE MITRAL VALVE REPAIR WITH THE MITRACLIP SYSTEM IN BARLOWS DISEASE. IT WAS REPORTED THAT A (B)(6)-YEAR-OLD FEMALE PATIENT WITH BARLOW¿S DISEASE UNDERWENT A MITRACLIP PROCEDURE TO TREAT DEGENERATIVE MITRAL REGURGITATION WITH GRADE 3. ONE CLIP WAS IMPLANTED REDUCING MR TO 1. ON 30 DAY THE DEVICE AND PROCEDURE WERE A SUCCESS. ON 12 MONTHS FOLLOW UP, THE PATIENT HAD RECURRENT MR. THERE WAS NO TREATMENT OR PROCEDURE PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Mitral Regurgitation

  MAUDE report 9875681 ↗
• DeathMar 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 DIED DUE TO MYOCARDIAL INFARCTION. THIS EVENT WAS CAPTURED BASED ON A REVIEW OF THE ARTICLE, PERCUTANEOUS EDGE TO EDGE MITRAL VALVE REPAIR WITH THE MITRACLIP SYSTEM IN BARLOWS DISEASE. IT WAS REPORTED THAT A 62-YEAR-OLD MALE PATIENT WITH BARLOW¿S DISEASE UNDERWENT A MITRACLIP PROCEDURE TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH GRADE 4. TWO CLIPS WERE IMPLANTED REDUCING MR TO <1. ON 30-DAY FOLLOW-UP, THE PATIENT WAS REPORTED AS OPTIMAL SUCCESS. 4 MONTHS LATER, THE PATIENT DIED DUE TO MYOCARDIAL INFARCTION. ADDITIONAL DETAILS ARE INCLUDED IN THE ATTACHED ARTICLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Death; Myocardial Infarction

  MAUDE report 9872401 ↗
• DeathMar 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 HAD RECURRENT MR, MR STENOSIS, MEDICAL INTERVENTION AND DEATH. IT WAS REPORTED THROUGH LITERATURE REVIEW, THAT A (B)(6)-YEAR-OLD FEMALE PATIENT WITH BARLOW¿S DISEASE UNDERWENT A MITRACLIP PROCEDURE TO TREAT DEGENERATIVE MITRAL REGURGITATION WITH GRADE 3 AND GRADIENT OF 8 MMHG. ONE CLIP WAS IMPLANTED REDUCING MR TO <1 BUT GRADIENT INCREASED TO 10 MMHG. ON 30-DAY FOLLOW-UP, THE PATIENT SUCCESS WAS MENTIONED AS NOT SUCCESSFUL. 6 MONTHS LATER, THE PATIENT WAS RE-HOSPITALIZED FOR HEART FAILURE DUE TO RECURRENT MR. THERE WAS NO TREATMENT REPORTED. ON 12 MONTHS FOLLOW UP, THE PATIENT HAD RECURRENT MR AT 3+. THERE WAS NO TREATMENT OR PROCEDURE PERFORMED. 14 MONTHS LATER, THE PATIENT DIED AFTER PERCUTANEOUS MITRAL REPAIR. ADDITIONAL DETAILS ARE LISTED IN THE ATTACHED ARTICLE TITLED, PERCUTANEOUS EDGE-TO-EDGE MITRAL VALVE REPAIR WITH THE MITRACLIP SYSTEM IN BARLOW¿S DISEASE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Death; Mitral Regurgitation; Mitral Valve Stenosis

  MAUDE report 9872287 ↗
• InjuryDec 18, 2019Incomplete Coaptation; Migration; Incomplete Coaptation; Migration

  THIS IS BEING FILED TO REPORT PARTIAL CLIP MOVEMENT, AND MEDICAL INTERVENTION. SUBSEQUENT TO THE COMBINED FILED REPORT, THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED: ON (B)(6) 2020, THE PATIENT RETURNED WITH SHORTNESS OF BREATH, AND THE MR GRADE WAS STILL 4. A REVISED IMAGING SHOWED THAT THE CLIP DID NOT BECOME DETACHED FROM THE POSTERIOR LEAFLET, BUT WAS MOBILE. THEREFORE, A A SECOND CLIP WAS DEPLOYED TO SECURE THE CLIP AND REDUCE MR. THE PATIENT IS STABLE. ONE ADDITIONAL CLIP WAS IMPLANTED, REDUCING MR TO 2. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Dyspnea; Mitral Regurgitation

  MAUDE report 9491100 ↗
• InjuryNov 25, 2019Incomplete Coaptation; Incomplete Coaptation

  SUBSEQUENT TO THE INITIALLY FILED REPORT, THE FOLLOWING INFORMATION WAS RECEIVED: ON (B)(6) 2019, THE PATIENT WAS RE-ADMITTED TO UNDERGO A SECOND MITRACLIP PROCEDURE TO TREAT RECURRENT MITRAL REGURGITATION (MR) WITH A GRADE OF 4+. AN ATTEMPT WAS MADE TO IMPLANT AN ADDITIONAL MITRACLIP. THE CLIP DELIVERY SYSTEM (CDS) WAS ADVANCED TO THE MITRAL VALVE; HOWEVER, WHEN THE CLIP GRASPED THE LEAFLETS ON THE MEDIAL SIDE, THE MEAN PRESSURE GRADIENT INCREASED TO 5MMHG. A DECISION WAS MADE TO GRASP ON THE LATERAL SIDE, AND THE MEAN PRESSURE GRADIENT WAS AT 2MMHG. BUT, THERE WAS NO MR REDUCTION. THE CLIP DELIVERY SYSTEM WAS REMOVED WITH THE CLIP ATTACHED AND THE PROCEDURE WAS ABORTED. THE OTHER PREVIOUSLY IMPLANTED CLIP REMAINS STABLE ON THE LEAFLETS. NO ADDITIONAL CLIPS WERE IMPLANTED, AND MR IS 4+. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Dyspnea; Mitral Regurgitation

  MAUDE report 9371875 ↗
• InjuryJun 14, 2019Incomplete Coaptation; Incomplete Coaptation

  SUBSEQUENT TO THE INITIALLY FILED MEDWATCH REPORT, THE FOLLOWING INFORMATION WAS RECEIVED: ON (B)(6) 2019, THE PATIENT UNDERWENT A SECOND MITRACLIP PROCEDURE. AN ADDITIONAL CLIP WAS IMPLANTED WITHOUT ISSUE, REDUCING MR FROM 4+ TO 2+. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Heart Failure; Mitral Regurgitation

  MAUDE report 8700201 ↗
• InjuryNov 6, 2017Incomplete Coaptation

  THIS REPORT IS FILED FOR INCREASED MITRAL REGURGITATION POST-PROCEDURE AND POSSIBLE SINGLE LEAFLET CLIP ATTACHMENT. IT WAS REPORTED THAT ON (B)(6) 2016, ONE MITRACLIP WAS IMPLANTED WITHOUT REPORTED ISSUE REDUCING DEGENERATIVE MITRAL REGURGITATION (MR). PATIENT ANATOMY WAS VERY CHALLENGING (ROTATED HEART AND ESOPHAGUS THAT WENT TO THE LEFT). ON (B)(6) 2017, AN ECHOCARDIOGRAM SHOWED MR HAD INCREASED TO GRADE 4. CLIP PLACEMENT WAS UNCERTAIN. ON (B)(6) 2017, A SECOND MITRACLIP PROCEDURE WAS PERFORMED. DUE TO THE CHALLENGING ANATOMY, ECHOCARDIOGRAM VISUALIZATION WAS DIFFICULT. IT WAS OBSERVED THAT THE FIRST IMPLANTED MITRACLIP HAD POSSIBLY DETACHED FROM THE ANTERIOR LEAFLET, A SINGLE LEAFLET DEVICE ATTACHMENT (SLDA); HOWEVER, VISUALIZATION WAS DIFFICULT. A SECOND MITRACLIP WAS SUCCESSFULLY IMPLANTED LATERAL TO THE FIRST REDUCING THE MR FROM GRADE 4 TO 2. THE PROCEDURE WAS COMPLETED AND THE PATIENT IS IN STABLE CONDITION.

  Patient problems: Mitral Regurgitation

  MAUDE report 7004419 ↗
• InjuryOct 23, 2017Incomplete Coaptation

  SUBSEQUENT TO THE INITIAL 30-DAY MEDWATCH REPORT, THE FOLLOWING INFORMATION WAS RECEIVED: ON (B)(6) 2017, THE PATIENT UNDERWENT ANOTHER MITRACLIP PROCEDURE FOR TREATMENT OF THE SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) AND INCREASED MITRAL REGURGITATION (MR). IT WAS DETERMINED THAT IT WAS THE SECOND CLIP (50526U153) THAT HAD DETACHED FROM THE POSTERIOR LEAFLET. THERE WAS AN ANTERIOR LEAFLET PROLAPSE AND THE MR GRADE WAS 4+. IN THE PHYSICIANS OPINION THE SLDA WAS DUE TO THE PATIENTS PRE-EXISTING ANATOMY; 1 CLIP WAS PLACED REDUCING MR TO 1+. THIS WAS AN EXCELLENT OUTCOME FOR THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Mitral Regurgitation

  MAUDE report 6970320 ↗
• InjuryOct 5, 2017Adverse Event Without Identified Device or Use Problem

  THIS IS FILED TO REPORT THE MITRAL STENOSIS. IT WAS REPORTED THAT THE INITIAL MITRACLIP PROCEDURE WAS PERFORMED ON (B)(6) 2016, TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 4. TWO CLIPS WERE IMPLANTED, REDUCING MR TO 1. AFTER THE INITIAL PROCEDURE, THE PRESSURE GRADIENT WAS 7MMHG; HOWEVER, THE PHYSICIAN DID NOT CONSIDER THIS MITRAL STENOSIS. ONE DAY POST-PROCEDURE, THE PHYSICIAN CONFIRMED THAT THE PATIENT WAS STABLE. ON (B)(6) 2017, THE PATIENT RETURNED WITH DYSPNEA. ECHOCARDIOGRAM WAS PERFORMED AND THE MEAN PRESSURE GRADIENT HAD INCREASED TO 9MMHG, WHICH THE PHYSICIAN NOW CONSIDERED MITRAL STENOSIS. THE IMPLANTED CLIPS WERE CONFIRMED TO BE STABLE ON THE LEAFLETS, AND THE MR HAD INCREASED TO 2 DUE TO PROGRESSION OF DISEASE. THE PATIENT WAS TREATED WITH MEDICATION, AND IS CURRENTLY STABLE. NO FURTHER TREATMENT WILL BE PERFORMED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Dyspnea; Mitral Valve Stenosis

  MAUDE report 6916357 ↗
• InjuryAug 7, 2017Incomplete Coaptation

  THIS IS FILED TO REPORT THE SINGLE LEAFLET DEVICE ATTACHMENT (SLDA). IT WAS REPORTED THAT TWO MITRACLIPS WERE IMPLANTED ON (B)(6) 2016 REDUCING MITRAL REGURGITATION (MR) FROM GRADE 4 TO 1. ON (B)(6) 2017 THE PATIENT WAS UNUSUALLY TIRED AND WENT IN FOR A CHECK UP. A TRANSTHORACIC ECHOCARDIOGRAM WAS PERFORMED AND FOUND A SUSPECTED SLDA AND AN MR OF 4. A TRANSESOPHAGEAL ECHOCARDIOGRAM WAS PERFORMED ON (B)(6) 2017 WHICH CONFIRMED THE SLDA AND A SECOND MITRACLIP PROCEDURE WAS PERFORMED, IMPLANTING TWO ADDITIONAL CLIPS AND REDUCING THE MR TO GRADE 1. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Fatigue; Mitral Regurgitation

  MAUDE report 6771639 ↗
• MalfunctionAug 2, 2017Break; Improper or Incorrect Procedure or Method

  THIS IS FILED TO REPORT THE GRIPPER LINE BREAK. IT WAS REPORTED THAT THIS WAS A MITRACLIP PROCEDURE TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 4+. THE CLIP DELIVERY SYSTEM (CDS) WAS ADVANCED TO THE MITRAL VALVE. WHEN CLIP DEPLOYMENT WAS STARTED, IT WAS FOUND THAT THE GRIPPER LINE WAS IN 2 PIECES. IT WAS NOTED THAT THE GRIPPER LEVER WAS PULLED BEYOND THE BLUE LINE. THE CDS WAS REMOVED AND REPLACED WITHOUT ISSUE. ONE CLIP WAS IMPLANTED, REDUCING THE MR TO <1. THERE WAS NO ADVERSE PATIENT SEQUELA OR A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6761434 ↗
• InjuryAug 1, 2017Failure To Adhere Or Bond; Difficult to Remove; Improper or Incorrect Procedure or Method

  THIS IS FILED TO REPORT THE CHORDAL RUPTURE. IT WAS REPORTED THAT THIS WAS A MITRACLIP PROCEDURE TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) WITH A GRADE OF 4. THE FIRST CLIP DELIVERY SYSTEM (CDS 60712U192) WAS ADVANCED, BUT THE CLIP BECAME CAUGHT ON THE CHORDAE. THE CLIP WAS ABLE TO BE FREED WITH TROUBLESHOOTING; HOWEVER, IT APPEARED THAT CHORDAL DAMAGE OCCURRED. THE CLIP WAS MOVED MEDIAL, AND IMPLANTED. THE MR REMAINED AT 4. THE SECOND CLIP DELIVERY SYSTEM (CDS 70201U116) WAS ADVANCED TO THE MITRAL VALVE; HOWEVER, THE CLIP REPEATEDLY BECAME CAUGHT ON THE ANTERIOR CHORDAE. THE CLIP WAS ABLE TO BE FREED; HOWEVER, ADDITIONAL CHORDAL DAMAGE OCCURRED AND THE MR INCREASED TO 4. IT WAS NOTED THAT IT WAS DIFFICULT TO MAINTAIN A CONSISTENT GOOD IMAGE AS THE ECHOCARDIOGRAPHER WAS INEXPERIENCED. THE LEAFLETS COULD NOT BE GRASPED; THEREFORE, THE PATIENT WAS SENT TO SURGERY FOR TREATMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Mitral Regurgitation; Tissue Damage

  MAUDE report 6758992 ↗
• InjuryAug 1, 2017Difficult to Remove; Improper or Incorrect Procedure or Method

  THIS IS FILED TO REPORT THE CHORDAL RUPTURE. IT WAS REPORTED THAT THIS WAS A MITRACLIP PROCEDURE TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) WITH A GRADE OF 4. THE FIRST CLIP DELIVERY SYSTEM (CDS 60712U192) WAS ADVANCED, BUT THE CLIP BECAME CAUGHT ON THE CHORDAE. THE CLIP WAS ABLE TO BE FREED WITH TROUBLESHOOTING; HOWEVER, IT APPEARED THAT CHORDAL DAMAGE OCCURRED. THE CLIP WAS MOVED MEDIAL, AND IMPLANTED. THE MR REMAINED AT 4. THE SECOND CLIP DELIVERY SYSTEM (CDS 70201U116) WAS ADVANCED TO THE MITRAL VALVE; HOWEVER, THE CLIP REPEATEDLY BECAME CAUGHT ON THE ANTERIOR CHORDAE. THE CLIP WAS ABLE TO BE FREED; HOWEVER, ADDITIONAL CHORDAL DAMAGE OCCURRED AND THE MR INCREASED TO 4. IT WAS NOTED THAT IT WAS DIFFICULT TO MAINTAIN A CONSISTENT GOOD IMAGE AS THE ECHOCARDIOGRAPHER WAS INEXPERIENCED. THE LEAFLETS COULD NOT BE GRASPED; THEREFORE, THE PATIENT WAS SENT TO SURGERY FOR TREATMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Tissue Damage

  MAUDE report 6758979 ↗
• InjuryJul 11, 2017Incomplete Coaptation

  THIS IS FILED TO REPORT THE SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) (60808U145) . IT WAS REPORTED THAT THE INITIAL MITRACLIP PROCEDURE WAS PERFORMED ON (B)(6) 2016 TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 4. ONE CLIP (60808U145) WAS IMPLANTED, REDUCING THE MR TO 1. ON (B)(6) 2017, A FOLLOW UP ECHOCARDIOGRAM WAS PERFORMED, AND IT WAS FOUND THAT THE CLIP DETACHED FROM THE ANTERIOR LEAFLET AND REMAINED ATTACHED TO THE POSTERIOR LEAFLET (SLDA). THE MR INCREASED TO 4. ON (B)(6) 2017, A SECOND PROCEDURE WAS PERFORMED FOR TREATMENT. ONE CLIP WAS IMPLANTED. THE SLDA CLIP WAS STABILIZED AND THE MR WAS REDUCED TO 3. THE SECOND CLIP (70224U166) WAS ADVANCED AND THE LEAFLETS WERE GRASPED; HOWEVER, THE MR WOULD INCREASE TO 4 WHILE GRASPING. THE DECISION WAS MADE TO DEPLOY THE CLIP WITH THE MR OF 4. AFTER DEPLOYMENT, THE CLIP DETACHED FROM THE POSTERIOR LEAFLET AND REMAINED ATTACHED TO THE ANTERIOR LEAFLET (SLDA). IT WAS NOTED THAT IMAGING WAS DIFFICULT DURING THE PROCEDURE DUE TO SHADOWING OF THE IMPLANTED CLIPS. THE PATIENT WAS TREATED WITH TRANS AORTIC VALVE REPLACEMENT, AND CONFIRMED TO BE STABLE POST PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Mitral Regurgitation

  MAUDE report 6701885 ↗
• InjuryJul 7, 2017Adverse Event Without Identified Device or Use Problem

  Unique Complaint ID Number,Initial or Supplement,Type of event,TTE in days,Device Brand Name,Medical device identifier,Device Codes;324241?1?1 ?;3172061?23801?;23309,,SI,752,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?1?1 ?;3209119?44009?;43240,,SI,349,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?1?1 ?;3266506?;113657?112139,,SI,844,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?1?1 ?;3303820?32131?;31552,,SI,35,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?1?1 ?;3312940?;101602?100162,,SI,712,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?1?1 ?;3333930?82193?;81035,,SI,650,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?1?1 ?;3364899?45305?;44531,,SI,370,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?1?1 ?;3389118?36799?;36152,,SI,530,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?1?1 ?;3397642?37412?;36745,,SI,490,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?1?1 ?;3420186?38907?;38

  Patient problems: Atrial Fibrillation; Heart Failure; Hemorrhage/Blood Loss/Bleeding; Mitral Regurgitation; No Code Available; No Information

  MAUDE report 6695461 ↗
• DeathJul 7, 2017Adverse Event Without Identified Device or Use Problem

  Unique Complaint ID Number,Initial or Supplement,Type of event,TTE in days,Device Brand Name,Medical device identifier,Device Codes;324241?2?1 ?;3123786?21582?;21961,,D,437,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?2?1 ?;3131990?22065?;21616,,D,995,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?2?1 ?;3141418?22488?;22011,,D,206,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?2?1 ?;3176098?23916?;23415,,D,375,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?2?1 ?;3231088?27641?;27067,,D,298,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?2?1 ?;3303820?32131?;31552,,D,349,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?2?1 ?;3352330?36016?;35390,,D,516,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?2?1 ?;3372768?70274?;69252,,D,767,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?2?1 ?;3376167?36012?;35387,,D,67,MITRACLIP SYSTEM Clip Delivery System,N/A,2993 ? No Known Device Problem;324241?2?1 ?;3420683?38949?;38264,,D,68,MIT

  Patient problems: Cardiac Arrest; Death; Neurological Deficit/Dysfunction; Unspecified Infection

  MAUDE report 6695458 ↗
• InjuryJul 3, 2017Failure To Adhere Or Bond; Incomplete Coaptation

  THIS IS FILED TO REPORT THE SINGLE LEAFLET DEVICE ATTACHMENT (SLDA).IT WAS REPORTED THAT THIS WAS A MITRACLIP PROCEDURE TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 4+. LEAFLET ASSESSMENT REVEALED THE ANTERIOR LEAFLET WAS LARGE WITH PROLAPSE AND FLAIL NOTED. THERE WAS DIFFICULTY GRASPING THE ANTERIOR LEAFLET; HOWEVER, THE CLIP WAS ABLE TO BE DEPLOYED ONTO THE LEAFLETS WITH A GOOD BITE ON THE POSTERIOR LEAFLET. WHEN THE LOCK LINE WAS 1/2 WAY OUT, A SLDA WAS OBSERVED WITH DETACHMENT OF THE CLIP FROM THE ANTERIOR LEAFLET. A SECOND CLIP WAS ADVANCED IN AN ATTEMPT TO STABILIZE THE FIRST CLIP; HOWEVER, NO MATTER WHERE IT WAS PLACED, LATERAL OR MEDIAL TO THE FIRST CLIP, THE MR DID NOT CHANGE. IT WAS BELIEVED THAT THE ANTERIOR LEAFLET HAD BECOME TORN DURING LEAFLET DETACHMENT; THEREFORE, THE DECISION WAS MADE TO ABORT THE PROCEDURE. FINAL MR WAS UNCHANGED AT GRADE 4+. THE PATIENT WAS STABLE POST PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Mitral Regurgitation; Tissue Damage

  MAUDE report 6684389 ↗
• InjuryJun 2, 2017Leak/Splash; Failure to Advance

  THIS REPORT IS FILED FOR THE AIR FOUND IN THE DEVICE AND THE ABNORMAL STEERING. IT WAS REPORTED THAT THE CLIP DELIVERY SYSTEM (CDS) WAS INSERTED THROUGH THE STEERABLE GUIDE CATHETER. AIR WAS NOTED IN THE HANDLE OF THE DELIVERY CATHETER AND THE GRIPPER LEVER OF THE CDS DURING THE PROCEDURE. THE AIR WAS RELEASED THROUGH THE RED CAP ON THE HANDLE AND THROUGH THE GRIPPER LEVER CAP. THE DRIP RATE WAS INCREASED. NO AIR ENTERED THE PATIENT. THE CLIP WAS UNABLE TO BE STEERED PERPENDICULAR TO THE MITRAL VALVE DUE TO THE ANGLE OF THE TRANSSEPTAL PUNCTURE. A NEW TRANSSEPTAL PUNCTURE WAS SUGGESTED, BUT THE PHYSICIAN DECLINED THAT SUGGESTION. AFTER 2 HOURS AND 18 MINUTES OF DEVICE TIME, IT WAS DECIDED TO END THIS PROCEDURE WITH ZERO CLIPS IMPLANTED. MITRAL REGURGITATION GRADE WAS UNCHANGED AT 3 TO 4. THE PATIENT WILL BE BROUGHT BACK FOR ANOTHER CLIP PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6609097 ↗
• InjuryMay 5, 2017Adverse Event Without Identified Device or Use Problem

  THIS IS FILED TO REPORT STROKE AND POSSIBLE AIR EMBOLISM. 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 CLIPS WERE IMPLANTED, REDUCING THE MR TO 2. THERE WAS NO ISSUE NOTED DURING THE PROCEDURE. ON (B)(6) 2017, THE PATIENT EXPERIENCED A STROKE AND WAS HOSPITALIZED. NO FURTHER TREATMENT HAS BEEN PLANNED. THE CAUSE OF THE STROKE IS UNKNOWN; HOWEVER, THE PHYSICIAN SUSPECTS THAT A POSSIBLE AIR EMBOLISM OCCURRED DURING THE MITRACLIP PROCEDURE. THE PATIENT IS CURRENTLY STABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Air Embolism; Stroke/CVA

  MAUDE report 6547770 ↗
• MalfunctionApr 27, 2017Mechanical Problem

  THIS IS FILED TO REPORT THAT THE CLIP OPENED DURING DEPLOYMENT. IT WAS REPORTED THAT THIS WAS A MITRACLIP PROCEDURE TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 4+. ONLY ONE CLIP WAS PLANNED AS THE PHYSICIAN DID NOT WANT THE PROCEDURE TO BE LONG DUE TO THE PATIENT AGE. THE STEERABLE GUIDE CATHETER (SGC) WAS ADVANCED, BUT RESISTANCE WAS MET WITH THE SEPTUM. THE SGC WAS REMOVED, AND THE SEPTUM WAS DILATED. THE SGC WAS THEN ADVANCED WITHOUT ISSUE. THE CLIP DELIVERY SYSTEM (CDS) WAS ADVANCED TO THE MITRAL VALVE AND THE LEAFLETS WERE GRASPED. DURING DEPLOYMENT, AFTER THE ACTUATOR KNOB WAS TURNED 8 TIMES, IT APPEARED THAT THE CLIP OPENED TO APPROXIMATELY 30 DEGREES (WHILE LOCKED). THE ONE CLIP WAS IMPLANTED, REDUCING THE MR TO 3+. THE PATIENT WAS CONFIRMED TO BE STABLE POST PROCEDURE, WITH IMPROVED HEMODYNAMICS. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6526029 ↗
• InjuryApr 7, 2017Incomplete Coaptation

  THIS IS FILED TO REPORT THE SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) RESULTING IN INCREASED MITRAL REGURGITATION AND HEART FAILURE. 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. ONE CLIP WAS IMPLANTED, REDUCING THE MR TO 1. THE NEXT DAY, DISCHARGE ECHOCARDIOGRAM CONFIRMED THE CLIP WAS STABLE, AND THE MR WAS 1. ON (B)(6) 2017, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH HEART FAILURE. ECHOCARDIOGRAM WAS PERFORMED WHICH FOUND THAT THE DEPLOYED CLIP HAD DETACHED FROM THE POSTERIOR LEAFLET AND REMAINED ATTACHED TO THE ANTERIOR LEAFLET (SINGLE LEAFLET DEVICE ATTACHMENT/SLDA). THE MR HAD INCREASED TO 4. THERE WAS NO TISSUE DAMAGE NOTED. THE PATIENT REMAINS STABLE AND WILL BE CONSIDERED FOR AN ADDITIONAL PROCEDURE AT A LATER DATE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Heart Failure; Mitral Regurgitation

  MAUDE report 6474394 ↗
• InjuryMar 30, 2017Break

  THIS IS FILED TO REPORT THAT THE GRIPPER LINE BROKE AND WAS LEFT IN THE ANATOMY. IT WAS REPORTED THAT THIS WAS A MITRACLIP PROCEDURE TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 4+. THE CLIP DELIVERY SYSTEM (CDS) WAS ADVANCED TO THE MITRAL VALVE. AFTER GRASPING, THE GRIPPER LINE REMOVABILITY WAS TESTED SUCCESSFULLY. DURING GRIPPER LINE REMOVABILITY, ONE END WAS PULLED WITHOUT ABNORMAL RESISTANCE UNTIL THE OTHER END WAS NO LONGER VISIBLE, BUT THE LINE BROKE. THE CDS WAS REMOVED AND THE REMAINING END OF THE GRIPPER LINE WAS PULLED FROM THE GUIDE, BUT THE LINE BROKE AGAIN IN THE GROIN. NO FURTHER ATTEMPTS WERE MADE TO REMOVE THE REMAINING PORTION OF GRIPPER LINE AND THE PATIENT WAS GIVEN MEDICATION TO PREVENT CLOTTING. THE PATIENT IS CURRENTLY STABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 6448344 ↗