FDA Adverse Event
Injury
Summary report: N
WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM
MDR report key: 15329439
·
Received August 31, 2022
Report
- Report Number
- 2124215-2022-32374
- Event Type
- Injury
- Date Received
- August 31, 2022
- Date of Event
- August 16, 2022
- Report Date
- August 31, 2022
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- NGV
- UDI-DI
- 08714729860501
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
IT WAS REPORTED THAT A DEVICE LEAK OCCURRED. ON (B)(6) 2022, A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS SUCCESSFULLY PERFORMED USING 27MM WATCHMAN FLX LAA CLOSURE DEVICE WITH DELIVERY SYSTEM (WDS). DURING A ROUTINE FOLLOW UP EXAMINATION ON (B)(6) 2022, 57 DAYS POST INDEX PROCEDURE, A COMPUTED TOMOGRAPHY ANGIOGRAM REVEALED A 4.8MM DEVICE LEAK. NO INTERVENTIONS TOOK PLACE AND THE PATIENT WAS DISCHARGED HOME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2068603 | WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM | SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL | NGV | BOSTON SCIENTIFIC CORPORATION | 10390 | 0029190563 | 08714729860501 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | Unknown | Other |