MITRACLIP G4 CLIP DELIVERY SYSTEM (MDR)
Report
- Report Number
- 2135147-2024-01697
- Event Type
- Injury
- Date Received
- April 15, 2024
- Date of Event
- March 21, 2024
- Report Date
- May 29, 2024
- Manufacturer
- ABBOTT MEDICAL
- Product Code
- NKM
- PMA / PMN Number
- P100009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE CLIP REMAINS IN THE PATIENT. THE DEVICE WILL NOT BE RETURNED 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. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO SIMILAR COMPLAINTS REPORTED FROM THIS LOT. BASED ON AVAILABLE INFORMATION, THE REPORTED EXPULSION, FOREIGN BODY IN PATIENT, DIFFICULT LEAFLET GRASPING, AND DIFFICULT LEAFLET CAPTURE APPEAR TO BE RELATED TO PROCEDURAL CONDITIONS (POOR IMAGING). A CAUSE FOR THE REPORTED POOR IMAGING COULD NOT BE DETERMINED. THE REPORTED UNEXPECTED MEDICAL INTERVENTION WAS A RESULT OF CASE-SPECIFIC CIRCUMSTANCES. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.
INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.
IT WAS REPORTED THIS WAS A MITRACLIP PROCEDURE TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 4 AND ANNULUS CALCIFICATION. IT WAS NOTED IMAGING WAS CHALLENGING THROUGHOUT THE PROCEDURE. AN NTW CLIP WAS INSERTED AND ADVANCED TO THE MITRAL VALVE. HOWEVER, THE CLIP CAME OFF BOTH LEAFLETS, AND DETACHED FROM THE CLIP DELIVERY SYSTEM (CDS). THE CLIP BECAME CAUGHT IN THE CHORDAE AND WAS ABLE TO BE REMOVED. THEREFORE, THE CLIP WAS REMOVED FROM THE ANATOMY AND REPLACED. THE PROCEDURE WAS CONTINUED, AND A NEW NTW CLIP WAS SUCCESSFULLY IMPLANTED, REDUCING MR TO A GRADE OF 2. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. SUBSEQUENT TO THE INITIALLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED STATING THE NTW CLIP WAS INSERTED AND DEPLOYED ON THE MITRAL VALVE. IT WAS NOTED GRASPING AND CAPTURING THE LEAFLETS WAS DIFFICULT. HOWEVER, AFTER DEPLOYMENT, THE CLIP EXPULSED AND BECAME CAUGHT IN THE CHORDAE. THE CLIP REMAINED IN THE CHORDAE.
IT WAS REPORTED THIS WAS A MITRACLIP PROCEDURE TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 4 AND ANNULUS CALCIFICATION. IT WAS NOTED IMAGING WAS CHALLENGING THROUGHOUT THE PROCEDURE. AN NTW CLIP WAS INSERTED AND ADVANCED TO THE MITRAL VALVE. HOWEVER, THE CLIP CAME OFF BOTH LEAFLETS, AND DETACHED FROM THE CLIP DELIVERY SYSTEM (CDS). THE CLIP BECAME CAUGHT IN THE CHORDAE AND WAS ABLE TO BE REMOVED. THEREFORE, THE CLIP WAS REMOVED FROM THE ANATOMY AND REPLACED. THE PROCEDURE WAS CONTINUED, AND A NEW NTW CLIP WAS SUCCESSFULLY IMPLANTED, REDUCING MR TO A GRADE OF 2. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. SUBSEQUENT TO THE INITIALLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED STATING THE NTW CLIP WAS INSERTED AND DEPLOYED ON THE MITRAL VALVE. IT WAS NOTED GRASPING AND CAPTURING THE LEAFLETS WAS DIFFICULT. HOWEVER, AFTER DEPLOYMENT, THE CLIP EXPULSED AND BECAME CAUGHT IN THE CHORDAE. THE CLIP REMAINED IN THE CHORDAE. THE LAST NTW WAS IMPLANTED TO FURTHER STABILIZE AND REDUCE TO THE MR TO GRADE 2.
IT WAS REPORTED THIS WAS A MITRACLIP PROCEDURE TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 4 AND ANNULUS CALCIFICATION. IT WAS NOTED IMAGING WAS CHALLENGING THROUGHOUT THE PROCEDURE. AN NTW CLIP WAS INSERTED AND ADVANCED TO THE MITRAL VALVE. HOWEVER, THE CLIP CAME OFF BOTH LEAFLETS, AND DETACHED FROM THE CLIP DELIVERY SYSTEM (CDS). THE CLIP BECAME CAUGHT IN THE CHORDAE AND WAS ABLE TO BE REMOVED. THEREFORE, THE CLIP WAS REMOVED FROM THE ANATOMY AND REPLACED. THE PROCEDURE WAS CONTINUED, AND A NEW NTW CLIP WAS SUCCESSFULLY IMPLANTED, REDUCING MR TO A GRADE OF 2. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1856126 | MITRACLIP G4 CLIP DELIVERY SYSTEM (MDR) | MITRAL VALVE REPAIR DEVICES | NKM | ABBOTT MEDICAL | 30814A1048 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 90 YR | Male | Required Intervention| O | STEERABLE GUIDE CATHETER |