MITRACLIP
Report
- Report Number
- 2135147-2025-04423
- Event Type
- Injury
- Date Received
- August 8, 2025
- Date of Event
- July 16, 2025
- Report Date
- August 29, 2025
- Manufacturer
- ABBOTT MEDICAL
- Product Code
- NKM
- UDI-DI
- 05415067037343
- PMA / PMN Number
- P100009
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
IN THIS CASE, THE REPORTED INCOMPLETE COAPTATION-INTRAPROCEDURE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO SIMILAR COMPLAINTS FROM THE LOT. ALL AVAILABLE INFORMATION WAS INVESTIGATED, AND THE REPORTED SLDA PER THE PHYSICIAN WAS RELATED TO PATIENT CONDITIONS (A BI-LEAFLET FLAIL AND PROLAPSED LEAFLETS). UNEXPECTED MEDICAL INTERVENTION WAS A RESULT OF CASE-SPECIFIC CIRCUMSTANCES. THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.
THE DEVICE REMAINS IMPLANTED IN 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.
IT WAS REPORTED ON (B)(6) 2025 A PATIENT PRESENTED WITH GRADE 4+ DEGENERATIVE MITRAL REGURGITATION (MR), A BI-LEAFLET FLAIL, AND PROLAPSED LEAFLETS FOR A MITRACLIP PROCEDURE. A MITRACLIP XTW WAS PLACED. UPON DEPLOYMENT A SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) WAS OBSERVED. THE CLIP DETACHED FROM THE POSTERIOR LEAFLET AND REMAINED ATTACHED TO THE ANTERIOR LEAFLET. TWO ADDITIONAL MITRACLIPS WERE IMPLANTED LATERAL TO THE FIRST CLIP AND ONE MITRACLIP WAS IMPLANTED MEDIAL TO THE FIRST CLIP TO STABILIZE AND REDUCE MR. THE FINAL MR GRADE WAS 2+.
IT WAS REPORTED ON (B)(6) 2025 A PATIENT PRESENTED WITH GRADE 4+ DEGENERATIVE MITRAL REGURGITATION (MR), A BI-LEAFLET FLAIL, AND PROLAPSED LEAFLETS FOR A MITRACLIP PROCEDURE. A MITRACLIP XTW WAS PLACED. UPON DEPLOYMENT A SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) WAS OBSERVED. THE CLIP DETACHED FROM THE POSTERIOR LEAFLET AND REMAINED ATTACHED TO THE ANTERIOR LEAFLET. TWO ADDITIONAL MITRACLIPS WERE IMPLANTED LATERAL TO THE FIRST CLIP AND ONE MITRACLIP WAS IMPLANTED MEDIAL TO THE FIRST CLIP TO STABILIZE AND REDUCE MR. THE FINAL MR GRADE WAS 2+.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 227304 | MITRACLIP | MITRAL VALVE REPAIR DEVICES | NKM | ABBOTT MEDICAL | CDS0707-XTW | 50128R1107 | 05415067037343 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |