MITRACLIP
Report
- Report Number
- 2135147-2024-03866
- Event Type
- Injury
- Date Received
- August 8, 2024
- Date of Event
- July 17, 2024
- Report Date
- August 20, 2024
- Manufacturer
- ABBOTT MEDICAL
- Product Code
- NKM
- UDI-DI
- 08717648288630
- PMA / PMN Number
- P100009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
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. BASED ON AVAILABLE INFORMATION, THE CAUSE OF THE REPORTED MITRAL STENOSIS WAS UNABLE TO BE DETERMINED. THE REPORTED PATIENT EFFECT OF MITRAL STENOSIS, AS LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE, IS A KNOWN POSSIBLE COMPLICATION ASSOCIATED WITH MITRACLIP PROCEDURES. THE REPORTED MEDICATION REQUIRED 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 A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT GRADE 4 DEGENERATIVE MITRAL REGURGITATION (MR). THE MITRAL VALVE PRESSURE GRADIENT (MVG) WAS NOTED TO BE 6MMHG. ONE CLIP WAS IMPLANTED, REDUCING MR TO 1-2. THE FOLLOWING DAY, THE MVG WAS MEASURED AND HAD INCREASED TO 10MMHG. THE PATIENT WAS DOING WELL, HOWEVER THE PHYSICIAN WAS TO INCREASE THE USE OF BETA BLOCKERS TO MANAGE THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2383372 | MITRACLIP | MITRAL VALVE REPAIR DEVICES | NKM | ABBOTT MEDICAL | 40205R1060 | 08717648288630 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR | Female | Required Intervention |