WATCHMAN FLX PRO LAA CLOSURE DEVICE WITH DELIVERY SYSTEM
Report
- Report Number
- 2124215-2025-20125
- Event Type
- Injury
- Date Received
- April 2, 2025
- Date of Event
- March 13, 2025
- Report Date
- April 21, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- NGV
- PMA / PMN Number
- P130013
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
B5: CORRECTION ADDED. D4 UNIQUE IDENTIFIER (UDI) #: DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. BASED ON THE NATURE OF THE INFORMATION PROVIDED TO BSC, IT IS NOT POSSIBLE TO PERFORM A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
D4 UNIQUE IDENTIFIER (UDI) #: DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. BASED ON THE NATURE OF THE INFORMATION PROVIDED TO BSC, IT IS NOT POSSIBLE TO PERFORM A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
IT WAS REPORTED THAT THROMBOSIS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED, AND WATCHMAN FLX PRO CLOSURE DEVICE(S) WERE IMPLANTED AS PART OF A CLINICAL STUDY. THE PATIENT(S) WERE DISCHARGED. THE PHYSICIAN WAS DISCUSSING THE ENROLLMENT STATUS WITH A BOSTON SCIENTIFIC PRINCIPAL CLINICAL RESEARCH ASSOCIATE FROM GLOBAL CLINICAL OPERATIONS AND MENTIONED THAT A FEW CLOTS HAVE BEEN SEEN ON THE WATCHMAN FLX PRO DEVICE(S). THE PHYSICIAN STATED THAT THE CLOTS HAVE BEEN CHALLENGING TO REMOVE. THE ACTUAL NUMBER OF PATIENTS, IMPLANT DATE, OR IF THERE WAS ANY INTERVENTION WAS NOT PROVIDED. NO ADVERSE EVENTS WERE REPORTED IN THE SUBJECT'S ENROLLED IN THE CLINICAL STUDIES AT THE SITE. THE PHYSICIAN ALSO EXPRESSED CONCERNS ABOUT THE EFFECTIVENESS OF THE NEW COATING IN PREVENTING CLOTS. NO FURTHER INFORMATION WAS PROVIDED OR COULD BE OBTAINED. THIS EVENT WAS FURTHER REVIEWED WAS FOUND TO BE A DUPLICATE RECORD TO PREVIOUSLY REPORTED EVENT(S), THEREFORE THIS COMPLAINT IS WITHDRAWN.
IT WAS REPORTED THAT THROMBOSIS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED, AND WATCHMAN FLX PRO CLOSURE DEVICE(S) WERE IMPLANTED AS PART OF A CLINICAL STUDY. THE PATIENT(S) WERE DISCHARGED. THE PHYSICIAN WAS DISCUSSING THE ENROLLMENT STATUS WITH A BOSTON SCIENTIFIC PRINCIPAL CLINICAL RESEARCH ASSOCIATE FROM GLOBAL CLINICAL OPERATIONS AND MENTIONED THAT A FEW CLOTS HAVE BEEN SEEN ON THE WATCHMAN FLX PRO DEVICE(S). THE PHYSICIAN STATED THAT THE CLOTS HAVE BEEN CHALLENGING TO REMOVE. THE ACTUAL NUMBER OF PATIENTS, IMPLANT DATE, OR IF THERE WAS ANY INTERVENTION WAS NOT PROVIDED. NO ADVERSE EVENTS WERE REPORTED IN THE SUBJECT'S ENROLLED IN THE CLINICAL STUDIES AT THE SITE. THE PHYSICIAN ALSO EXPRESSED CONCERNS ABOUT THE EFFECTIVENESS OF THE NEW COATING IN PREVENTING CLOTS. NO FURTHER INFORMATION WAS PROVIDED OR COULD BE OBTAINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 744600 | WATCHMAN FLX PRO LAA CLOSURE DEVICE WITH DELIVERY SYSTEM | SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL | NGV | BOSTON SCIENTIFIC CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |