WATCHMAN FLX? PRO
Report
- Report Number
- 2124215-2024-50346
- Event Type
- Injury
- Date Received
- August 14, 2024
- Date of Event
- June 18, 2024
- Report Date
- March 31, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- NGV
- UDI-DI
- 00191506004583
- PMA / PMN Number
- P130013
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
B5: INFORMATION ADDED.
THIS REPORT WAS AMENDED TO UPDATE INTERNATIONAL MEDICAL DEVICE REGULATORS FORUM (IMDRF) CODES. INCOMPLETE CODING OF THIS EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS ASSOCIATED WITH CAPA-8580, WHICH FOCUSED ON IDENTIFYING AND REMEDIATING INCOMPLETE CODING OF EVENTS. H6: ADDED PATIENT CODES HEADACHE AND SPEECH DISORDERS. WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC (BSC) CONCLUDES: DEVICE TECHNICAL ANALYSIS: THE WATCHMAN FLX? PRO REMAINS IMPLANTED; THEREFORE, RETURNED DEVICE ANALYSIS COULD NOT BE COMPLETED. DEVICE HISTORY RECORD REVIEW: A REVIEW WAS COMPLETED OF THE DEVICE HISTORY RECORDS (DHR) FOR THE WATCHMAN FLX? PRO, PART # M635WU60200 BATCH # 0032178038. 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. 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 TRANSIENT ISCHEMIC ATTACK (TIA) (HEADACHE, SPEECH DISORDERS) (MEDICATION AND IMAGING REQUIRED). RISK REVIEW: A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE EVENT OF TRANSIENT ISCHEMIC ATTACK (TIA) (HEADACHE, SPEECH DISORDERS) WAS 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: BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE.
HEAL LAA STUDY. IT WAS REPORTED THAT A TRANSIENT ISCHEMIC ATTACK (TIA) OCCURRED. PRIOR TO THE INDEX PROCEDURE, HEPARIN WAS ADMINISTERED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED, AND A 20MM WATCHMAN FLX PRO CLOSURE DEVICE WAS IMPLANTED WITH A COMPLETE LAA SEAL AND A DEPLOYED DEVICE DIAMETER OF 17MM. AFTER THE IMPLANT THE PATIENT WAS CONTINUED ON ASPIRIN AND CLOPIDOGREL. THE PATIENT WAS DISCHARGED THE SAME DAY. ON (B)(6) 2024, 217 DAYS POST INDEX PROCEDURE, THE PATIENT EXPERIENCED A 10 TO 30 MINUTES LONG EPISODE OF EXPRESSIVE APHASIA, POST CORONARY ANGIOGRAPHY PROCEDURE. THE PATIENT HAD UNDERWENT PLANNED CORONARY ANGIOGRAPHY TO ASSESS ATYPICAL CHEST PAIN THAT HAD BEEN AN ONGOING ISSUE PRIOR TO ENROLLMENT IN STUDY. ON THE SAME DAY OF PRESENTATION, THE APHASIA RESOLVED YET THE PATIENT HAD RESIDUAL HEADACHE. THE PATIENT HAD BEEN ON ASPIRIN AND CLOPIDOGREL AND THE EVENT HAD BEEN CONSIDERED RESOLVED THE SAME DAY WITH SEQUELAE. ON (B)(6) 2024, THE PATIENT PRESENTED TO THE HOSPITAL AND A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED AND THE PATIENT WAS DIAGNOSED WITH TRANSIENT ISCHEMIC ATTACKS (TIA) POSSIBLY CAUSED BY DISLODGED DEBRIS DURING THE CORONARY ANGIOGRAPHY PROCEDURE. MAGNETIC RESONANCE IMAGING (MRI) AND ELECTROENCEPHALOGRAM WAS ALSO PERFORMED AS DIAGNOSTICS. A NON-ANTIPLATELET/NON-ANTICOAGULANT WAS USED TO TREAT THE TIA EVENT. PER THE PHYSICIAN'S OPINION, THIS EVENT IS NOT RELATED TO THE IMPLANTED CLOSURE DEVICE OR LAA CLOSURE PROCEDURE.
(B)(4) STUDY. IT WAS REPORTED THAT A TRANSIENT ISCHEMIC ATTACK (TIA) OCCURRED. PRIOR TO THE INDEX PROCEDURE, HEPARIN WAS ADMINISTERED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED, AND A 20MM WATCHMAN FLX PRO CLOSURE DEVICE WAS IMPLANTED WITH A COMPLETE LAA SEAL AND A DEPLOYED DEVICE DIAMETER OF 17MM. AFTER THE IMPLANT THE PATIENT WAS CONTINUED ON ASPIRIN AND CLOPIDOGREL. THE PATIENT WAS DISCHARGED THE SAME DAY. ON (B)(6) 2024, 217 DAYS POST INDEX PROCEDURE, THE PATIENT EXPERIENCED A 10 TO 30 MINUTES LONG EPISODE OF EXPRESSIVE APHASIA, POST CORONARY ANGIOGRAPHY PROCEDURE. THE PATIENT HAD UNDERWENT PLANNED CORONARY ANGIOGRAPHY TO ASSESS ATYPICAL CHEST PAIN THAT HAD BEEN AN ONGOING ISSUE PRIOR TO ENROLLMENT IN STUDY. ON THE SAME DAY OF PRESENTATION, THE APHASIA RESOLVED YET THE PATIENT HAD RESIDUAL HEADACHE. THE PATIENT HAD BEEN ON ASPIRIN AND CLOPIDOGREL AND THE EVENT HAD BEEN CONSIDERED RESOLVED THE SAME DAY WITH SEQUELAE. ON (B)(6) 2024, THE PATIENT PRESENTED TO THE HOSPITAL AND A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED AND THE PATIENT WAS DIAGNOSED WITH TRANSIENT ISCHEMIC ATTACKS (TIA) POSSIBLY CAUSED BY DISLODGED DEBRIS DURING THE CORONARY ANGIOGRAPHY PROCEDURE. MAGNETIC RESONANCE IMAGING (MRI) AND ELECTROENCEPHALOGRAM WAS ALSO PERFORMED AS DIAGNOSTICS. A NON-ANTIPLATELET/NON-ANTICOAGULANT WAS USED TO TREAT THE TIA EVENT. PER THE PHYSICIAN'S OPINION, THIS EVENT IS NOT RELATED TO THE IMPLANTED CLOSURE DEVICE OR LAA CLOSURE PROCEDURE. IT WAS FURTHER REPORTED THAT THE MRI THAT WAS PERFORMED ON (B)(6) 2024 REVEALED NO ACUTE ISCHEMIA OR OTHER ACUTE INTRACRANIAL PROCESS, NO ABNORMAL ENHANCEMENT, WITH PROBABLE CHRONIC SMALL VESSEL ISCHEMIC CHANGE WITH PRIOR HEMORRHAGIC LACUNAR INFARCT IN THE LEFT BASAL GANGLIA. ON THE SAME DAY, CTA REVEALED PROGRESSIVE HYPODENSITIES IN THE LEFT FRONTAL DEEP WHITE MATTER LIKELY REPRESENTING INTERVAL ISCHEMIC EVENTS. THE PATIENT WAS DISCHARGED HOME FOLLOWING THE EMERGENCY DEPARTMENT VISIT ON (B)(6) 2024.
HEAL LAA STUDY: IT WAS REPORTED THAT A TRANSIENT ISCHEMIC ATTACK (TIA) OCCURRED. PRIOR TO THE INDEX PROCEDURE, HEPARIN WAS ADMINISTERED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED, AND A 20MM WATCHMAN FLX PRO CLOSURE DEVICE WAS IMPLANTED WITH A COMPLETE LAA SEAL AND A DEPLOYED DEVICE DIAMETER OF 17MM. AFTER THE IMPLANT THE PATIENT WAS CONTINUED ON ASPIRIN AND CLOPIDOGREL. THE PATIENT WAS DISCHARGED THE SAME DAY. ON (B)(6) 2024, 217 DAYS POST INDEX PROCEDURE, THE PATIENT EXPERIENCED A 10 TO 30 MINUTES LONG EPISODE OF EXPRESSIVE APHASIA, POST CORONARY ANGIOGRAPHY PROCEDURE. THE PATIENT HAD UNDERWENT PLANNED CORONARY ANGIOGRAPHY TO ASSESS ATYPICAL CHEST PAIN THAT HAD BEEN AN ONGOING ISSUE PRIOR TO ENROLLMENT IN STUDY. ON THE SAME DAY OF PRESENTATION, THE APHASIA RESOLVED YET THE PATIENT HAD RESIDUAL HEADACHE. THE PATIENT HAD BEEN ON ASPIRIN AND CLOPIDOGREL AND THE EVENT HAD BEEN CONSIDERED RESOLVED THE SAME DAY WITH SEQUELAE. ON (B)(6) 2024, THE PATIENT PRESENTED TO THE HOSPITAL AND A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED AND THE PATIENT WAS DIAGNOSED WITH TRANSIENT ISCHEMIC ATTACKS (TIA) POSSIBLY CAUSED BY DISLODGED DEBRIS DURING THE CORONARY ANGIOGRAPHY PROCEDURE. MAGNETIC RESONANCE IMAGING (MRI) AND ELECTROENCEPHALOGRAM WAS ALSO PERFORMED AS DIAGNOSTICS. A NON-ANTIPLATELET/NON-ANTICOAGULANT WAS USED TO TREAT THE TIA EVENT. PER THE PHYSICIAN'S OPINION, THIS EVENT IS NOT RELATED TO THE IMPLANTED CLOSURE DEVICE OR LAA CLOSURE PROCEDURE. IT WAS FURTHER REPORTED THAT THE MRI THAT WAS PERFORMED ON (B)(6) 2024 REVEALED NO ACUTE ISCHEMIA OR OTHER ACUTE INTRACRANIAL PROCESS, NO ABNORMAL ENHANCEMENT, WITH PROBABLE CHRONIC SMALL VESSEL ISCHEMIC CHANGE WITH PRIOR HEMORRHAGIC LACUNAR INFARCT IN THE LEFT BASAL GANGLIA. ON THE SAME DAY, CTA REVEALED PROGRESSIVE HYPODENSITIES IN THE LEFT FRONTAL DEEP WHITE MATTER LIKELY REPRESENTING INTERVAL ISCHEMIC EVENTS. THE PATIENT WAS DISCHARGED HOME FOLLOWING THE EMERGENCY DEPARTMENT VISIT ON (B)(6) 2024.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 303285 | WATCHMAN FLX? PRO | SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL | NGV | BOSTON SCIENTIFIC CORPORATION | M635WU60200 | 0032178038 | 00191506004583 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Male | Required Intervention |