WATCHMAN FLX? PRO
Report
- Report Number
- 2124215-2024-49229
- Event Type
- Injury
- Date Received
- August 9, 2024
- Date of Event
- July 25, 2024
- Report Date
- March 26, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- NGV
- UDI-DI
- 00191506004613
- PMA / PMN Number
- P130013
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC (BSC) CONCLUDES: DEVICE HISTORY RECORD REVIEW: A REVIEW WAS COMPLETED OF THE DEVICE HISTORY RECORDS (DHR) FOR THE WATCHMAN FLX PRO, PART # M635WU60310, BATCH # 0033255322. THE DEVICE WAS PROCESSED THROUGH ALL NORMAL OPERATIONAL CONDITIONS AND PASSED ALL ACCEPTANCE ACTIVITIES. THE DHR REVIEW DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMANCES THAT COULD HAVE CONTRIBUTED TO THE EVENT. DEVICE TECHNICAL ANALYSIS: THE WATCHMAN FLX PRO WAS NOT RETURNED, THEREFORE RETURNED DEVICE ANALYSIS COULD NOT BE COMPLETED. LABELING REVIEW: THERE WAS NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS USED IN A MANNER INCONSISTENT WITH THE LABELING. WATCHMAN FLX PRO INSTRUCTIONS FOR USE (IFU) LISTS POTENTIAL COMPLICATIONS, RISKS AND ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THIS DEVICE WHICH INCLUDE CEREBRAL VASCULAR ACCIDENT (CVA) (HOSPITALIZATION AND IMAGING REQUIRED). RISK REVIEW: A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE EVENTS OF CEREBRAL VASCULAR ACCIDENT (CVA) WERE DEFINED IN THE RISK DOCUMENTATION. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. INVESTIGATION CONCLUSION: BSC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE.
H6: IMPACT CODE - ADDED F2203. WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC (BSC) CONCLUDES: DEVICE HISTORY RECORD REVIEW: A REVIEW WAS COMPLETED OF THE DEVICE HISTORY RECORDS (DHR) FOR THE WATCHMAN FLX PRO, PART # M635WU60310, BATCH # 0033255322. THE DEVICE WAS PROCESSED THROUGH ALL NORMAL OPERATIONAL CONDITIONS AND PASSED ALL ACCEPTANCE ACTIVITIES. THE DHR REVIEW DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMANCES THAT COULD HAVE CONTRIBUTED TO THE EVENT. DEVICE TECHNICAL ANALYSIS: THE WATCHMAN FLX PRO WAS NOT RETURNED, THEREFORE RETURNED DEVICE ANALYSIS COULD NOT BE COMPLETED. LABELING REVIEW: THERE WAS NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS USED IN A MANNER INCONSISTENT WITH THE LABELING. WATCHMAN FLX PRO INSTRUCTIONS FOR USE (IFU) LISTS POTENTIAL COMPLICATIONS, RISKS AND ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THIS DEVICE WHICH INCLUDE CEREBRAL VASCULAR ACCIDENT (CVA) (HOSPITALIZATION). RISK REVIEW: A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE EVENTS OF CEREBRAL VASCULAR ACCIDENT (CVA) WERE DEFINED IN THE RISK DOCUMENTATION. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. INVESTIGATION CONCLUSION: BSC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE.
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A CEREBRAL VASCULAR ACCIDENT. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED, AND A 31MM WATCHMAN FLX PRO CLOSURE DEVICE WAS IMPLANTED. IT WAS NOTED THAT THE ACTIVATED CLOTTING TIME (ACT) WAS GREATER THAN 300 SECONDS DURING THE PROCEDURE. AFTER THE LEFT ATRIAL APPENDAGE CLOSURE PROCEDURE WAS COMPLETED, THE PATIENT RETURNED TO THE RECOVERY WARD. AT AN UNSPECIFIED TIME POST PROCEDURE, A COLLAPSE OF THE LOWER LIMBS WAS NOTED, AND A HEAD MAGNETIC RESONANCE IMAGING (MRI) WAS PERFORMED. IMAGES OF CEREBRAL INFARCTION WERE OBSERVED. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR TREATMENT. THERE WAS NO FURTHER INFORMATION AVAILABLE OR PROVIDED.
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A CEREBRAL VASCULAR ACCIDENT. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED, AND A 31MM WATCHMAN FLX PRO CLOSURE DEVICE WAS IMPLANTED. IT WAS NOTED THAT THE ACTIVATED CLOTTING TIME (ACT) WAS GREATER THAN 300 SECONDS DURING THE PROCEDURE. AFTER THE LEFT ATRIAL APPENDAGE CLOSURE PROCEDURE WAS COMPLETED, THE PATIENT RETURNED TO THE RECOVERY WARD. AT AN UNSPECIFIED TIME POST PROCEDURE, A COLLAPSE OF THE LOWER LIMBS WAS NOTED, AND A HEAD MAGNETIC RESONANCE IMAGING (MRI) WAS PERFORMED. IMAGES OF CEREBRAL INFARCTION WERE OBSERVED. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR TREATMENT. THERE WAS NO FURTHER INFORMATION AVAILABLE OR PROVIDED.
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A CEREBRAL VASCULAR ACCIDENT. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED, AND A 31MM WATCHMAN FLX PRO CLOSURE DEVICE WAS IMPLANTED. IT WAS NOTED THAT THE ACTIVATED CLOTTING TIME (ACT) WAS GREATER THAN 300 SECONDS DURING THE PROCEDURE. AFTER THE LEFT ATRIAL APPENDAGE CLOSURE PROCEDURE WAS COMPLETED, THE PATIENT RETURNED TO THE RECOVERY WARD. AT AN UNSPECIFIED TIME POST PROCEDURE, A COLLAPSE OF THE LOWER LIMBS WAS NOTED, AND A HEAD MAGNETIC RESONANCE IMAGING (MRI) WAS PERFORMED. IMAGES OF CEREBRAL INFARCTION WERE OBSERVED. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR TREATMENT. THERE WAS NO FURTHER INFORMATION AVAILABLE OR PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 541168 | WATCHMAN FLX? PRO | SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL | NGV | BOSTON SCIENTIFIC CORPORATION | M635WU60310 | 0033255322 | 00191506004613 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other| H |