FDA Adverse Event
Injury
Summary report: N
WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM
MDR report key: 11806996
·
Received May 11, 2021
Report
- Report Number
- 2134265-2021-06123
- Event Type
- Injury
- Date Received
- May 11, 2021
- Date of Event
- March 3, 2021
- Report Date
- May 11, 2021
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- NGV
- UDI-DI
- 08714729860488
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT DEVICE EMBOLIZATION OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 20MM WATCHMAN FLX LAA CLOSURE DEVICE WAS IMPLANTED AFTER MEETING RELEASE CRITERIA. THE PATIENT HAD SOME NECK PAIN THAT SAME DAY, AND THE DEVICE WAS FOUND TO HAVE EMBOLIZED TO THE INFRA-RENAL AORTA. THE DEVICE WAS EXPLANTED VIA VASCULAR SURGERY ON (B)(6) 2021. THE PATIENT WAS REPORTED TO BE STABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 704532 | WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM | SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL | NGV | BOSTON SCIENTIFIC CORPORATION | 10390 | 0026134676 | 08714729860488 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |