WATCHMAN FLX
Report
- Report Number
- 2124215-2025-12020
- Event Type
- Injury
- Date Received
- February 27, 2025
- Date of Event
- December 20, 2024
- Report Date
- March 31, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- NGV
- UDI-DI
- 08714729860488
- PMA / PMN Number
- P130013
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
B3: USED JOURNAL ARTICLE ACCEPTED DATE AS EVENT DATE, AS IT IS UNKNOWN. MEDICAL MEDIA WAS PROVIDED WITHIN THE JOURNAL ARTICLE AND REVIEWED BY BSC QUALITY ENGINEERS FOR RELEVANCE TO THE COMPLAINT ALLEGATION. THE MEDIA PROVIDED DID NOT APPEAR TO DEPICT ANY DEVICE OR USER RELATED ALLEGATIONS AND RESULTED IN NO QUESTIONS REQUIRING FURTHER INVESTIGATION LITERATURE CITATION: LAI, LKL, ALRAYES, H, FRAM, G. ET AL. STEP-BY-STEP ICE-GUIDED ASPIRATION THROMBECTOMY: GASTROINTESTINAL BLEEDING PATIENT WITH DEVICE-RELATED THROMBUS ON WATCHMAN FLX. J AM COLL CARDIOL CASE REP. 2025 FEB, 30 (3). HTTPS://DOI.ORG/10.1016/J.JACCAS.2024.103219.
B3: USED JOURNAL ARTICLE ACCEPTED DATE AS EVENT DATE, AS IT IS UNKNOWN. LITERATURE CITATION: LAI, LKL, ALRAYES, H, FRAM, G. ET AL. STEP-BY-STEP ICE-GUIDED ASPIRATION THROMBECTOMY: GASTROINTESTINAL BLEEDING PATIENT WITH DEVICE-RELATED THROMBUS ON WATCHMAN FLX. J AM COLL CARDIOL CASE REP. 2025 FEB, 30 (3). HTTPS://DOI.ORG/10.1016/J.JACCAS.2024.103219.
REPORTED VIA JOURNAL ARTICLE. IT WAS REPORTED THAT THROMBOSIS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED, AND A 20MM WATCHMAN FLX CLOSURE DEVICE WAS IMPLANTED. THE PATIENT WAS DISCHARGED ON APIXABAN. AT THE 45-DAY ROUTINE FOLLOW UP, TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) IMAGING REVEALED A HIGHLY MOBILE DEVICE RELATED THROMBUS (DRT) MEASURING 0.7CM X 1 CM THAT WAS ADHERENT TO THE CLOSURE DEVICE. THE PATIENT REPORTED COMPLIANCE WITH HER ANTICOAGULATION REGIMEN. THE PATIENT REQUIRED AN INTRACARDIAC ECHOCARDIOGRAM (ICE) IMAGING GUIDED ASPIRATION THROMBECTOMY PROCEDURE. THE THROMBUS WAS FULLY REMOVED AND THERE WAS NO RESIDUAL THROMBUS ATTACHED TO THE CLOSURE DEVICE. THE PATIENT WAS DISCHARGED ON WARFARIN AND ASPIRIN MEDICATION. A FOLLOW UP TEE WAS PERFORMED AT THREE (3) MONTHS AND SHOWED COMPLETE RESOLUTION OF THE DRT. THE WARFARIN WAS DISCONTINUED, AND THE PATIENT WAS KEPT ON A REGIMEN OF ASPIRIN ALONE.
REPORTED VIA JOURNAL ARTICLE. IT WAS REPORTED THAT THROMBOSIS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED, AND A 20MM WATCHMAN FLX CLOSURE DEVICE WAS IMPLANTED. THE PATIENT WAS DISCHARGED ON APIXABAN. AT THE 45-DAY ROUTINE FOLLOW UP, TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) IMAGING REVEALED A HIGHLY MOBILE DEVICE RELATED THROMBUS (DRT) MEASURING 0.7CM X 1 CM THAT WAS ADHERENT TO THE CLOSURE DEVICE. THE PATIENT REPORTED COMPLIANCE WITH HER ANTICOAGULATION REGIMEN. THE PATIENT REQUIRED AN INTRACARDIAC ECHOCARDIOGRAM (ICE) IMAGING GUIDED ASPIRATION THROMBECTOMY PROCEDURE. THE THROMBUS WAS FULLY REMOVED AND THERE WAS NO RESIDUAL THROMBUS ATTACHED TO THE CLOSURE DEVICE. THE PATIENT WAS DISCHARGED ON WARFARIN AND ASPIRIN MEDICATION. A FOLLOW UP TEE WAS PERFORMED AT THREE (3) MONTHS AND SHOWED COMPLETE RESOLUTION OF THE DRT. THE WARFARIN WAS DISCONTINUED, AND THE PATIENT WAS KEPT ON A REGIMEN OF ASPIRIN ALONE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 666173 | WATCHMAN FLX | SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL | NGV | BOSTON SCIENTIFIC CORPORATION | M635WU50200 | 08714729860488 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Female | Required Intervention |