WATCHMAN FLX? PRO
Report
- Report Number
- 2124215-2026-07159
- Event Type
- Injury
- Date Received
- February 9, 2026
- Date of Event
- October 17, 2025
- Report Date
- March 24, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- NGV
- UDI-DI
- 00191506004620
- PMA / PMN Number
- P130013
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC (BSC) CONCLUDES: DEVICE TECHNICAL ANALYSIS: THE WATCHMAN FLX? PRO REMAINS IMPLANTED; THEREFORE, RETURNED DEVICE ANALYSIS COULD NOT BE COMPLETED. DEVICE HISTORY RECORD REVIEW: A REVIEW WAS COMPLETED OF THE DEVICE HISTORY RECORDS (DHR) FOR THE WATCHMAN FLX? PRO, PART # M635WU60350 BATCH # 0036706784. THE DEVICE WAS PROCESSED THROUGH ALL NORMAL OPERATIONAL CONDITIONS AND PASSED ALL ACCEPTANCE ACTIVITIES. THE DHR REVIEW DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMANCES THAT COULD HAVE CONTRIBUTED TO THE EVENT. LABELING REVIEW: THERE WAS NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS USED IN A MANNER INCONSISTENT WITH THE LABELING. WATCHMAN FLX? PRO INSTRUCTIONS FOR USE (IFU) LISTS POTENTIAL COMPLICATIONS, RISKS AND ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THIS DEVICE WHICH INCLUDE IMPLANT DID NOT SEAL. RISK REVIEW: A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE EVENT OF IMPLANT DID NOT SEAL WAS DEFINED IN THE RISK DOCUMENTATION. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. INVESTIGATION CONCLUSION: BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE.
REPORTED VIA CLINICAL STUDY. IT WAS REPORTED THAT A DEVICE LEAK OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED. ON (B)(6) 2025, THE PATIENT WAS CROSSOVER TO DEVICE GROUP AND UNDERWENT SUCCESSFUL PLACEMENT OF A 35MM WATCHMAN FLX PRO CLOSURE DEVICE. THE PATIENT WAS DISCHARGED ON APIXABAN (10 MG /DAY). ON (B)(6) 2025, 49 DAYS POST IMPLANT PROCEDURE, THE PATIENT PRESENTED FOR PROTOCOL REQUIRED CROSSOVER 4-MONTH LAA-IMAGING AND COMPUTED TOMOGRAPHY (CT) ASSESSMENT REVEALED A JET SIZE GREATER THAT 5MM WITH LARGEST RESIDUAL JET AROUND DEVICE OF 7MM AT OSTIUM. THERE WAS NO THROMBUS ON THE ATRIAL-FACING SURFACE OF THE CLOSURE DEVICE OR IN THE LEFT ATRIUM. NO PERICARDIAL EFFUSION OR RESIDUAL ATRIAL SEPTAL SHUNT WAS NOTED. ALSO ESTIMATED LEFT VENTRICULAR EJECTION FRACTION (LVEF) WAS UNKNOWN. AT THE TIME OF THE EVENT, THE PATIENT WAS ON APIXABAN (10 MG /DAY). NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
REPORTED VIA CLINICAL STUDY. IT WAS REPORTED THAT A DEVICE LEAK OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED. ON (B)(6) 2025, THE PATIENT WAS CROSSOVER TO DEVICE GROUP AND UNDERWENT SUCCESSFUL PLACEMENT OF A 35MM WATCHMAN FLX PRO CLOSURE DEVICE. THE PATIENT WAS DISCHARGED ON APIXABAN (10 MG /DAY). ON (B)(6) 2025, 49 DAYS POST IMPLANT PROCEDURE, THE PATIENT PRESENTED FOR PROTOCOL REQUIRED CROSSOVER 4-MONTH LAA-IMAGING AND COMPUTED TOMOGRAPHY (CT) ASSESSMENT REVEALED A JET SIZE GREATER THAT 5MM WITH LARGEST RESIDUAL JET AROUND DEVICE OF 7MM AT OSTIUM. THERE WAS NO THROMBUS ON THE ATRIAL-FACING SURFACE OF THE CLOSURE DEVICE OR IN THE LEFT ATRIUM. NO PERICARDIAL EFFUSION OR RESIDUAL ATRIAL SEPTAL SHUNT WAS NOTED. ALSO ESTIMATED LEFT VENTRICULAR EJECTION FRACTION (LVEF) WAS UNKNOWN. AT THE TIME OF THE EVENT, THE PATIENT WAS ON APIXABAN (10 MG /DAY). NO FURTHER INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 374231 | WATCHMAN FLX? PRO | SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL | NGV | BOSTON SCIENTIFIC CORPORATION | M635WU60350 | 0036706784 | 00191506004620 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Male | Other |