MITRACLIP
Report
- Report Number
- 2135147-2025-05081
- Event Type
- Injury
- Date Received
- September 8, 2025
- Date of Event
- August 14, 2025
- Report Date
- October 15, 2025
- Manufacturer
- ABBOTT MEDICAL
- Product Code
- DRA
- UDI-DI
- 08717648231025
- PMA / PMN Number
- K190167
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE DEVICE IS NOT RETURNING FOR EVALUATION. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.
THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. THE INVESTIGATION WAS UNABLE TO DETERMINE A CAUSE FOR THE REPORTED PERFORATION AND HYPOXIA. PERFORATION IS LISTED IN THE INSTRUCTIONS FOR USE AND IS A KNOWN POSSIBLE COMPLICATION ASSOCIATED WITH MITRACLIP PROCEDURES. THE REPORTED HOSPITALIZATION AND UNEXPECTED MEDICAL INTERVENTION WERE RESULT OF CASE SPECIFIC CIRCUMSTANCE. THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.
IT WAS REPORTED ON (B)(6) 2025 THAT THE PATIENT PRESENTED WITH GRADE 4+ FUNCTIONAL MITRAL REGURGITATION (MR) AND DILATED LEFT AND RIGHT VENTRICLE FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, ONE MITRACLIP WAS SUCCESSFULLY IMPLANTED. FOLLOWING DEPLOYMENT OF A SECOND MITRACLIP XTW, MITRAL REGURGITATION (MR) WORSENED. A THIRD MITRACLIP NTW WAS ATTEMPTED; HOWEVER, RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE CLIP LATERAL TO THE XTW. FLUOROSCOPY REVEALED ENTANGLEMENT BETWEEN THE NTW AND XTW CLIPS. DURING TROUBLESHOOTING, IT WAS OBSERVED THAT THE XTW GRIPPERS WERE NOT ENGAGED WITH THE LEAFLETS, AND ITS GRIPPER ASSEMBLY REMAINED INTACT WITH THE DISTAL END OF THE NTW, CONTRIBUTING TO THE ENTANGLEMENT. SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) OF THE XTW CLIP FROM THE ANTERIOR LEAFLET OCCURRED DURING THE DISENTANGLEMENT PROCESS. THE NTW CLIP WAS SUCCESSFULLY DEPLOYED WITH ADEQUATE LEAFLET GRASP. A ATRIAL SEPTAL DEFECT (ASD) HAD OCCURRED. PATIENT EXPERIENCED HYPOXIA. A NON-ABBOTT DEVICE WAS USED FOR ASD CLOSURE. THE PATIENT WAS PLACED ON INTRA-AORTIC BALLOON PUMP (IABP) SUPPORT IN INTENSIVE CARE UNIT (ICU). POST-PROCEDURE, MR WAS REDUCED TO GRADE 3+. THERE WAS NO CLINICALLY SIGNIFICANT PROCEDURAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.
IT WAS REPORTED ON (B)(6) 2025 THAT THE PATIENT PRESENTED WITH GRADE 4+ FUNCTIONAL MITRAL REGURGITATION (MR) AND DILATED LEFT AND RIGHT VENTRICLE FOR A MITRACLIP PROCEDURE. DURING THE PROCEDURE, ONE MITRACLIP WAS SUCCESSFULLY IMPLANTED. FOLLOWING DEPLOYMENT OF A SECOND MITRACLIP XTW, MITRAL REGURGITATION (MR) WORSENED. A THIRD MITRACLIP NTW WAS ATTEMPTED; HOWEVER, RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE CLIP LATERAL TO THE XTW. FLUOROSCOPY REVEALED ENTANGLEMENT BETWEEN THE NTW AND XTW CLIPS. DURING TROUBLESHOOTING, IT WAS OBSERVED THAT THE XTW GRIPPERS WERE NOT ENGAGED WITH THE LEAFLETS, AND ITS GRIPPER ASSEMBLY REMAINED INTACT WITH THE DISTAL END OF THE NTW, CONTRIBUTING TO THE ENTANGLEMENT. SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) OF THE XTW CLIP FROM THE ANTERIOR LEAFLET OCCURRED DURING THE DISENTANGLEMENT PROCESS. THE NTW CLIP WAS SUCCESSFULLY DEPLOYED WITH ADEQUATE LEAFLET GRASP. A ATRIAL SEPTAL DEFECT (ASD) HAD OCCURRED. PATIENT EXPERIENCED HYPOXIA. A NON-ABBOTT DEVICE WAS USED FOR ASD CLOSURE. THE PATIENT WAS PLACED ON INTRA-AORTIC BALLOON PUMP (IABP) SUPPORT IN INTENSIVE CARE UNIT (ICU). POST-PROCEDURE, MR WAS REDUCED TO GRADE 3+. THERE WAS NO CLINICALLY SIGNIFICANT PROCEDURAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2497411 | MITRACLIP | CATHETER, STEERABLE | DRA | ABBOTT MEDICAL | SGC0701 | 41123A3018 | 08717648231025 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Male | Hospitalization| R | MITRACLIP.| STEERABLE GUIDE CATHETER. |