WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM
Report
- Report Number
- 2134265-2021-06723
- Event Type
- Injury
- Date Received
- May 24, 2021
- Date of Event
- May 3, 2021
- Report Date
- January 25, 2024
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- NGV
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
E1: INITIAL REPORTER FACILITY NAME - (B)(6).
E1: INITIAL REPORTER FACILITY NAME - (B)(6).
B5: UPDATED.
OPTION STUDY. IT WAS REPORTED THAT THROMBOSIS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 27MM WATCHMAN FLX LAA CLOSURE DEVICE WAS IMPLANTED WITH A COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 23 MM. POST IMPLANT THE PATIENT WAS STARTED ON EDOXABAN AND ASPIRIN. THE PATIENT WAS DISCHARGED ON (B)(6) 2021 AND WAS REPORTED TO HAVE BEEN COMPLIANT WITH THE POST IMPLANT MEDICATION REGIMEN. ON (B)(6) 2021, 108 DAYS POST INDEX PROCEDURE, COMPUTED TOMOGRAPHY (CT) IMAGING DURING THE THREE MONTH FOLLOW-UP VISIT REVEALED A THROMBUS ON THE ATRIAL FACING SURFACE OF THE 27MM WATCHMAN FLX DEVICE. A TRANSTHORACIC ECHO (TTE) REVEALED THE THROMBUS WAS LAMINAR AND NON-MOBILE. THERE WAS NO THROMBUS NOTED AT THE LEFT ATRIUM. THE PATENT'S ORAL MEDICATION WAS CHANGED/ADJUSTED. NO ADDITIONAL INFORMATION IS KNOWN AT THIS TIME. IT WAS FURTHER REPORTED THAT THE EVENT WAS CONSIDERED NOT RECOVERED/NOT RESOLVED. NO FURTHER INFORMATION PERTAINING TO THE EVENT IS AVAILABLE.
OPTION STUDY. IT WAS REPORTED THAT THROMBOSIS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 27MM WATCHMAN FLX LAA CLOSURE DEVICE WAS IMPLANTED WITH A COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 23 MM. POST IMPLANT THE PATIENT WAS STARTED ON EDOXABAN AND ASPIRIN. THE PATIENT WAS DISCHARGED ON (B)(6) 2021 AND WAS REPORTED TO HAVE BEEN COMPLIANT WITH THE POST IMPLANT MEDICATION REGIMEN. ON (B)(6) 2021, 108 DAYS POST INDEX PROCEDURE, COMPUTED TOMOGRAPHY (CT) IMAGING DURING THE THREE-MONTH FOLLOW-UP VISIT REVEALED A THROMBUS ON THE ATRIAL FACING SURFACE OF THE 27MM WATCHMAN FLX DEVICE. A TRANSTHORACIC ECHO (TTE) REVEALED THE THROMBUS WAS LAMINAR AND NON-MOBILE. THERE WAS NO THROMBUS NOTED AT THE LEFT ATRIUM. THE PATENT'S ORAL MEDICATION WAS CHANGED/ADJUSTED. NO ADDITIONAL INFORMATION IS KNOWN AT THIS TIME. IT WAS FURTHER REPORTED THAT PRIOR TO IMPLANTATION, THE PATIENT UNDERWENT ATRIAL FIBRILLATION ABLATION USING THE PULMONARY VEIN ISOLATION TECHNIQUE WITH CRYO METHOD. PRIOR TO THE INDEX PROCEDURE, ASPIRIN WAS NOT ADMINISTERED AND AFTER THE IMPLANT PROCEDURE THE PATIENT WAS STARTED ON ASPIRIN AND EDOXABAN WAS CONTINUED. ON (B)(6) 2022, 697 DAYS POST INDEX PROCEDURE, A TTE WAS PERFORMED WHICH REVEALED A SUSPECTED PERI-DEVICE LEAK. ON THE SAME DAY, ORAL MEDICATION CHANGE/ADJUSTMENT WAS DONE TO TREAT THE EVENT. AT THE TIME OF REPORTING THE EVENT IS STILL ONGOING.
OPTION STUDY IT WAS REPORTED THAT THROMBOSIS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 27MM WATCHMAN FLX LAA CLOSURE DEVICE WAS IMPLANTED WITH A COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 23 MM. POST IMPLANT THE PATIENT WAS STARTED ON EDOXABAN AND ASPIRIN. THE PATIENT WAS DISCHARGED ON (B)(6) 2021 AND WAS REPORTED TO HAVE BEEN COMPLIANT WITH THE POST IMPLANT MEDICATION REGIMEN. ON (B)(6) 2021, 108 DAYS POST INDEX PROCEDURE, COMPUTED TOMOGRAPHY (CT) IMAGING DURING THE THREE-MONTH FOLLOW-UP VISIT REVEALED A THROMBUS ON THE ATRIAL FACING SURFACE OF THE 27MM WATCHMAN FLX DEVICE. A TRANSTHORACIC ECHO (TTE) REVEALED THE THROMBUS WAS LAMINAR AND NON-MOBILE. THERE WAS NO THROMBUS NOTED AT THE LEFT ATRIUM. THE PATENT'S ORAL MEDICATION WAS CHANGED/ADJUSTED. NO ADDITIONAL INFORMATION IS KNOWN AT THIS TIME. IT WAS FURTHER REPORTED THAT PRIOR TO IMPLANTATION, THE PATIENT UNDERWENT ATRIAL FIBRILLATION ABLATION USING THE PULMONARY VEIN ISOLATION TECHNIQUE WITH CRYO METHOD. PRIOR TO THE INDEX PROCEDURE, ASPIRIN WAS NOT ADMINISTERED AND AFTER THE IMPLANT PROCEDURE THE PATIENT WAS STARTED ON ASPIRIN AND EDOXABAN WAS CONTINUED. ON (B)(6) 2022, 697 DAYS POST INDEX PROCEDURE, A TTE WAS PERFORMED WHICH REVEALED A SUSPECTED PERI-DEVICE LEAK. ON THE SAME DAY, ORAL MEDICATION CHANGE/ADJUSTMENT WAS DONE TO TREAT THE EVENT. AT THE TIME OF REPORTING THE EVENT IS STILL ONGOING. IT WAS FURTHER REPORTED THAT ON (B)(6) 2022, THE EVENT OF THROMBOSIS WAS CONSIDERED RESOLVED.
INITIAL REPORTER FACILITY NAME - (B)(6).
(B)(6) STUDY. IT WAS REPORTED THAT THROMBOSIS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 27MM WATCHMAN FLX LAA CLOSURE DEVICE WAS IMPLANTED WITH A COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 23MM. POST IMPLANT THE PATIENT WAS STARTED ON EDOXABAN AND ASPIRIN. THE PATIENT WAS DISCHARGED ON (B)(6) 2021 AND WAS REPORTED TO HAVE BEEN COMPLIANT WITH THE POST IMPLANT MEDICATION REGIMEN. ON (B)(6) 2021, 108 DAYS POST INDEX PROCEDURE, COMPUTED TOMOGRAPHY (CT) IMAGING DURING THE THREE MONTH FOLLOW-UP VISIT REVEALED A THROMBUS ON THE ATRIAL FACING SURFACE OF THE 27MM WATCHMAN FLX DEVICE. A TRANSTHORACIC ECHO (TTE) REVEALED THE THROMBUS WAS LAMINAR AND NON-MOBILE. THERE WAS NO THROMBUS NOTED AT THE LEFT ATRIUM. THE PATENT'S ORAL MEDICATION WAS CHANGED/ADJUSTED. NO ADDITIONAL INFORMATION IS KNOWN AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 766485 | WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM | SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL | NGV | BOSTON SCIENTIFIC CORPORATION | 10390 | 0025453382 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Female | Other |