MITRACLIP
Report
- Report Number
- 2135147-2025-01216
- Event Type
- Injury
- Date Received
- March 11, 2025
- Date of Event
- February 14, 2025
- Report Date
- March 25, 2025
- Manufacturer
- ABBOTT MEDICAL
- Product Code
- NKM
- UDI-DI
- 08717648288630
- PMA / PMN Number
- P100009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
IT IS UNKNOWN IF THE DEVICE IS RETURNING FOR ANALYSIS. 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 VASCULAR DISSECTION AND PLEURAL EFFUSION. VASCULAR DISSECTION AND PLEURAL EFFUSION ARE LISTED IN THE INSTRUCTIONS FOR USE ARE KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH MITRACLIP PROCEDURES. THE REPORTED MEDICATION REQUIRED AND UNEXPECTED MEDICAL INTERVENTION WERE RESULTS OF CASE SPECIFIC CIRCUMSTANCES AS VASOPRESSORS AND FLUID REPLACEMENT WAS ADMINISTERED AND A STENT GRAFT WAS PLACED TO TREAT THE DISSECTION. THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. CODES REMOVED: HEALTH EFFECT-CLINICAL CODE: 2010.
IT WAS REPORTED THAT ON (B)(6) 2025, A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) GRADE 4. A NTW CLIP WAS CHOSEN FOR IMPLANTATION. THE NTW GRASPED A2/P2, BUT MR REMAINED LATERAL AND BLOOD PRESSURE ROSE 10MMHG. IN ORDER TO REDUCED RESIDUAL MR, THE NTW WAS RE-POSITIONED WHICH RESULTED IN REDUCTION IN MR AND LEFT ATRIAL PRESSURE. HOWEVER, A DECREASE IN BLOOD PRESSURE AND CONTRACTION OF THE LEFT ATRIUM OCCURRED. VASOPRESSORS AND FLUID REPLACEMENT WAS ADMINISTERED BUT THE PATIENT DID NOT STABILIZE. HEMOTHORAX WAS THEN OBSERVED, AND A DISSECTION OF THE DESCENDING AORTA WAS OBSERVED ON ECHOCARDIOGRAPHY. THE NTW CLIP WAS REMOVED AND A STENT GRAFT WAS PLACED TO TREAT THE DISSECTION. THE PATIENT WAS REPORTED TO BE EXTUBATED AND STABLE.
IT WAS REPORTED THAT ON (B)(6) 2025, A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) GRADE 4. A NTW CLIP WAS CHOSEN FOR IMPLANTATION. THE NTW GRASPED A2/P2, BUT MR REMAINED LATERAL AND BLOOD PRESSURE ROSE 10MMHG. IN ORDER TO REDUCED RESIDUAL MR, THE NTW WAS RE-POSITIONED WHICH RESULTED IN REDUCTION IN MR AND LEFT ATRIAL PRESSURE. HOWEVER, A DECREASE IN BLOOD PRESSURE AND CONTRACTION OF THE LEFT ATRIUM OCCURRED. VASOPRESSORS AND FLUID REPLACEMENT WAS ADMINISTERED BUT THE PATIENT DID NOT STABILIZE. HEMOTHORAX WAS THEN OBSERVED, AND A DISSECTION OF THE DESCENDING AORTA WAS OBSERVED ON ECHOCARDIOGRAPHY. THE NTW CLIP WAS REMOVED AND A STENT GRAFT WAS PLACED TO TREAT THE DISSECTION. THE PATIENT WAS REPORTED TO BE EXTUBATED AND STABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1221701 | MITRACLIP | MITRAL VALVE REPAIR DEVICES | NKM | ABBOTT MEDICAL | 40710R1110 | 08717648288630 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Female | Required Intervention | STEERABLE GUIDE CATHETER |