WATCHMAN FLX? PRO
Report
- Report Number
- 2124215-2024-67803
- Event Type
- Death
- Date Received
- October 31, 2024
- Date of Event
- October 24, 2024
- Report Date
- May 7, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- NGV
- UDI-DI
- 00191506004590
- PMA / PMN Number
- P130013
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
H6 PATIENT CODE ADDED: RENAL FAILURE. H6 IMPACT CODES ADDED: ADDITIONAL DEVICE REQUIRED, REHABILITATION, DEATH.
B5: INFORMATION ADDED AND CORRECTED.
B5: INFORMATION ADDED. H6 PATIENT CODES ADDED: FACIAL PARALYSIS, MUSCLE WEAKNESS/ATROPHY. H6 IMPACT CODE ADDED: MEDICATION REQUIRED, INTENSIVE CARE.
B5: INFORMATION ADDED. H6 PATIENT CODE ADDED: CONVULSION/SEIZURE.
THE PATIENT WAS PART OF A CLINICAL STUDY IT WAS REPORTED A STROKE OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 24MM WATCHMAN FLX PRO CLOSURE DEVICE WAS IMPLANTED WITH A COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 18.9 MM. THE PATIENT WAS DISCHARGED ON ASPIRIN AND WARFARIN. 167 DAYS POST INDEX PROCEDURE, THE PATIENT PRESENTED TO THE HOSPITAL FOR A T2 VERTEBRAL FRACTURE. AT THE TIME OF THE EVENT, THE PATIENT WAS ON ASPIRIN AND WARFARIN. BRAIN IMAGING AND COMPUTED TOMOGRAPHY (CT) WAS PERFORMED, ALONG WITH OTHER DIAGNOSTICS. THE PATIENT WAS ADMITTED TO THE HOSPITAL. 185 DAYS POST INDEX PROCEDURE, THE PATIENT UNDERWENT BRAIN IMAGING, CT IMAGING, MAGNETIC RESONANCE IMAGING (MRI), AND OTHER DIAGNOSTICS. THE PATIENT WAS DIAGNOSED WITH ISCHEMIC STROKE. THAT SAME DAY, THE EVENT WAS CONSIDERED RESOLVED WITH SEQUALAE. IT WAS FURTHER ADDED THAT THE PATIENT HAD PRESENTED TO THE HOSPITAL 185 DAYS POST INDEX PROCEDURE POST HEMODIALYSIS (HD) DUE TO END STAGE RENAL DISEASE (ESRD), AND AFTER THE COMPLETION OF THAT HD THE PATIENT HAD NEW RIGHT SIDED FACIAL DROOP AND RIGHT SIDED ARM AND LEG WEAKNESS. THE EMERGENCY DEPARTMENT ADMINISTERED OMNIPAQUE INTRAVENOUSLY. THE INITIAL NATIONAL INSITUTE OF HEALTH STROKE SCALE SCORE WAS 4. TENECTEPLASE (TNK) WAS ADMINISTERED IN RESPONSE TO THE ISCHEMIC STROKE AND THE PATIENT WAS TAKEN TO THE NEURO INTENSIVE CARE UNIT (ICU) FOR MONITORING. DUAL ANTIPLATELET (DAPT) MEDICATION WAS HELD AND INSTRUCTED TO RESUME AT A LATER DATE. TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) IMAGING PERFORMED REVEALED COMPLETE LAA SEAL, AND NO THROMBUS IN THE LEFT ATRIUM OR ON THE ATRIAL FACING SURFACE OF THE CLOSURE DEVICE. THE PATIENT WAS DISCHARGED 190 DAYS POST INDEX PROCEDURE. IT WAS FURTHER REPORTED THAT ON (B)(6) 2024, 207 DAYS POST INDEX PROCEDURE, THE PATIENT PRESENTED WITH COMPLAINTS OF LEFT SIDED WEAKNESS AND WAS DIAGNOSED WITH ACUTE ISCHEMIC RIGHT ANTERIOR CEREBRAL ARTERY STROKE VIA A MAGNETIC RESONANCE IMAGING (MRI) SCAN WHICH REVEALED A MODERATE SIZED ACUTE/RECENT RIGHT MEDIAL FRONTAL INFARCT. AT THE TIME OF THE EVENT, THE PATIENT WAS ON ASPIRIN. THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT AND WAS TREATED WITH NON-ANTIPLATELET/NON-ANTICOAGULANT MEDICATIONS AND A PACEMAKER WAS IMPLANTED. THE PATIENT WAS DISCHARGED ON(B)(6) 2024, TO A SKILLED NURSING/REHABILITATION FACILITY. THE PATIENT DIED THE FOLLOWING DAY ON (B)(6)2024. THE CAUSE OF DEATH WAS LISTED AS WORSENING END STAGE RENAL DISEASE.
THE PATIENT WAS PART OF A CLINICAL STUDY. IT WAS REPORTED A STROKE OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 24MM WATCHMAN FLX PRO CLOSURE DEVICE WAS IMPLANTED WITH A COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 18.9 MM. THE PATIENT WAS DISCHARGED ON ASPIRIN AND WARFARIN. 167 DAYS POST INDEX PROCEDURE, THE PATIENT PRESENTED TO THE HOSPITAL FOR A T2 VERTEBRAL FRACTURE. AT THE TIME OF THE EVENT, THE PATIENT WAS ON ASPIRIN AND WARFARIN. BRAIN IMAGING AND COMPUTED TOMOGRAPHY (CT) WAS PERFORMED, ALONG WITH OTHER DIAGNOSTICS. THE PATIENT WAS ADMITTED TO THE HOSPITAL. 185 DAYS POST INDEX PROCEDURE, THE PATIENT UNDERWENT BRAIN IMAGING, CT IMAGING, MAGNETIC RESONANCE IMAGING (MRI), AND OTHER DIAGNOSTICS. THE PATIENT WAS DIAGNOSED WITH ISCHEMIC STROKE. THAT SAME DAY, THE EVENT WAS CONSIDERED RESOLVED WITH SEQUALAE. IT WAS FURTHER ADDED THAT THE PATIENT HAD PRESENTED TO THE HOSPITAL 185 DAYS POST INDEX PROCEDURE POST HEMODIALYSIS (HD) DUE TO END STAGE RENAL DISEASE (ESRD), AND AFTER THE COMPLETION OF THAT HD THE PATIENT HAD NEW RIGHT SIDED FACIAL DROOP AND RIGHT SIDED ARM AND LEG WEAKNESS. THE EMERGENCY DEPARTMENT ADMINISTERED OMNIPAQUE INTRAVENOUSLY. THE INITIAL NATIONAL INSTITUTE OF HEALTH STROKE SCALE SCORE WAS 4. TENECTEPLASE (TNK) WAS ADMINISTERED IN RESPONSE TO THE ISCHEMIC STROKE AND THE PATIENT WAS TAKEN TO THE NEURO INTENSIVE CARE UNIT (ICU) FOR MONITORING. DUAL ANTIPLATELET (DAPT) MEDICATION WAS HELD AND INSTRUCTED TO RESUME AT A LATER DATE. TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) IMAGING PERFORMED REVEALED COMPLETE LAA SEAL, AND NO THROMBUS IN THE LEFT ATRIUM OR ON THE ATRIAL FACING SURFACE OF THE CLOSURE DEVICE. THE PATIENT WAS DISCHARGED 190 DAYS POST INDEX PROCEDURE. IT WAS FURTHER REPORTED THAT ON (B)(6)2024, 207 DAYS POST INDEX PROCEDURE, THE PATIENT PRESENTED WITH COMPLAINTS OF LEFT SIDED WEAKNESS AND WAS DIAGNOSED WITH ACUTE ISCHEMIC RIGHT ANTERIOR CEREBRAL ARTERY STROKE VIA A MAGNETIC RESONANCE IMAGING (MRI) SCAN WHICH REVEALED A MODERATE SIZED ACUTE/RECENT RIGHT MEDIAL FRONTAL INFARCT. AT THE TIME OF THE EVENT, THE PATIENT WAS ON ASPIRIN. THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT AND WAS TREATED WITH NON-ANTIPLATELET/NON-ANTICOAGULANT MEDICATIONS AND A PACEMAKER WAS IMPLANTED. THE PATIENT WAS DISCHARGED ON (B)(6) 2024, TO A SKILLED NURSING/REHABILITATION FACILITY. THE PATIENT DIED THE FOLLOWING DAY ON (B)(6) 2024. THE CAUSE OF DEATH WAS LISTED AS WORSENING END STAGE RENAL DISEASE. IT WAS FURTHER CORRECTED THAT THE PATIENT DIED ON (B)(6) 2024. IT WAS FURTHER ADDED THAT THE PATIENT HAD THE PACEMAKER IMPLANTED ON (B)(6) 2024, BUT THEN HAD THE PACEMAKER REMOVED FROM THE BODY ON (B)(6) 2024, AND THE PATIENT WAS CONSULTED WITH PALLIATIVE CARE THEN DISCHARGED TO THE SKILLED NURSING/REHABILITATION FACILITY.
THE PATIENT WAS PART OF A CLINICAL STUDY. IT WAS REPORTED A STROKE OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 24MM WATCHMAN FLX PRO CLOSURE DEVICE WAS IMPLANTED WITH A COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 18.9 MM. THE PATIENT WAS DISCHARGED ON ASPIRIN AND WARFARIN. 167 DAYS POST INDEX PROCEDURE, THE PATIENT PRESENTED TO THE HOSPITAL FOR A T2 VERTEBRAL FRACTURE. AT THE TIME OF THE EVENT, THE PATIENT WAS ON ASPIRIN AND WARFARIN. BRAIN IMAGING AND COMPUTED TOMOGRAPHY (CT) WAS PERFORMED, ALONG WITH OTHER DIAGNOSTICS. THE PATIENT WAS ADMITTED TO THE HOSPITAL. 185 DAYS POST INDEX PROCEDURE, THE PATIENT UNDERWENT BRAIN IMAGING, CT IMAGING, MAGNETIC RESONANCE IMAGING (MRI), AND OTHER DIAGNOSTICS. THE PATIENT WAS DIAGNOSED WITH ISCHEMIC STROKE. THAT SAME DAY, THE EVENT WAS CONSIDERED RESOLVED WITH SEQUALAE. IT WAS FURTHER ADDED THAT THE PATIENT HAD PRESENTED TO THE HOSPITAL 185 DAYS POST INDEX PROCEDURE POST HEMODIALYSIS (HD) DUE TO END STAGE RENAL DISEASE (ESRD), AND AFTER THE COMPLETION OF THAT HD THE PATIENT HAD NEW RIGHT SIDED FACIAL DROOP AND RIGHT SIDED ARM AND LEG WEAKNESS. THE EMERGENCY DEPARTMENT ADMINISTERED OMNIPAQUE INTRAVENOUSLY. THE INITIAL NATIONAL INSITUTE OF HEALTH STROKE SCALE SCORE WAS 4. TENECTEPLASE (TNK) WAS ADMINISTERED IN RESPONSE TO THE ISCHEMIC STROKE AND THE PATIENT WAS TAKEN TO THE NEURO INTENSIVE CARE UNIT (ICU) FOR MONITORING. DUAL ANTIPLATELET (DAPT) MEDICATION WAS HELD AND INSTRUCTED TO RESUME AT A LATER DATE. TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) IMAGING PERFORMED REVEALED COMPLETE LAA SEAL, AND NO THROMBUS IN THE LEFT ATRIUM OR ON THE ATRIAL FACING SURFACE OF THE CLOSURE DEVICE. THE PATIENT WAS DISCHARGED 190 DAYS POST INDEX PROCEDURE.
THE PATIENT WAS PART OF A CLINICAL STUDY. IT WAS REPORTED A STROKE OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 24MM WATCHMAN FLX PRO CLOSURE DEVICE WAS IMPLANTED WITH A COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 18.9 MM. THE PATIENT WAS DISCHARGED ON ASPIRIN AND WARFARIN. 167 DAYS POST INDEX PROCEDURE, THE PATIENT PRESENTED TO THE HOSPITAL FOR A T2 VERTEBRAL FRACTURE. AT THE TIME OF THE EVENT, THE PATIENT WAS ON ASPIRIN AND WARFARIN. BRAIN IMAGING AND COMPUTED TOMOGRAPHY (CT) WAS PERFORMED, ALONG WITH OTHER DIAGNOSTICS. THE PATIENT WAS ADMITTED TO THE HOSPITAL. 185 DAYS POST INDEX PROCEDURE, THE PATIENT UNDERWENT BRAIN IMAGING, CT IMAGING, MAGNETIC RESONANCE IMAGING (MRI), AND OTHER DIAGNOSTICS. THE PATIENT WAS DIAGNOSED WITH ISCHEMIC STROKE. THAT SAME DAY, THE EVENT WAS CONSIDERED RESOLVED WITH SEQUALAE. IT WAS FURTHER ADDED THAT THE PATIENT HAD PRESENTED TO THE HOSPITAL 185 DAYS POST INDEX PROCEDURE POST HEMODIALYSIS (HD) DUE TO END STAGE RENAL DISEASE (ESRD), AND AFTER THE COMPLETION OF THAT HD THE PATIENT HAD NEW RIGHT SIDED FACIAL DROOP AND RIGHT SIDED ARM AND LEG WEAKNESS. THE EMERGENCY DEPARTMENT ADMINISTERED OMNIPAQUE INTRAVENOUSLY. THE INITIAL NATIONAL INSITUTE OF HEALTH STROKE SCALE SCORE WAS 4. TENECTEPLASE (TNK) WAS ADMINISTERED IN RESPONSE TO THE ISCHEMIC STROKE AND THE PATIENT WAS TAKEN TO THE NEURO INTENSIVE CARE UNIT (ICU) FOR MONITORING. DUAL ANTIPLATELET (DAPT) MEDICATION WAS HELD AND INSTRUCTED TO RESUME AT A LATER DATE. TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) IMAGING PERFORMED REVEALED COMPLETE LAA SEAL, AND NO THROMBUS IN THE LEFT ATRIUM OR ON THE ATRIAL FACING SURFACE OF THE CLOSURE DEVICE. THE PATIENT WAS DISCHARGED 190 DAYS POST INDEX PROCEDURE. IT WAS FURTHER REPORTED THAT ON (B)(6) 2024, 207 DAYS POST INDEX PROCEDURE, THE PATIENT PRESENTED WITH COMPLAINTS OF LEFT SIDED WEAKNESS AND WAS DIAGNOSED WITH ACUTE ISCHEMIC RIGHT ANTERIOR CEREBRAL ARTERY STROKE VIA A MAGNETIC RESONANCE IMAGING (MRI) SCAN WHICH REVEALED A MODERATE SIZED ACUTE/RECENT RIGHT MEDIAL FRONTAL INFARCT. AT THE TIME OF THE EVENT, THE PATIENT WAS ON ASPIRIN. THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT AND WAS TREATED WITH NON-ANTIPLATELET/NON-ANTICOAGULANT MEDICATIONS AND A PACEMAKER WAS IMPLANTED. THE PATIENT WAS DISCHARGED ON (B)(6) 2024, TO A SKILLED NURSING/REHABILITATION FACILITY. THE PATIENT DIED THE FOLLOWING DAY ON (B)(6) 2024. THE CAUSE OF DEATH WAS LISTED AS WORSENING END STAGE RENAL DISEASE. IT WAS FURTHER CORRECTED THAT THE PATIENT DIED ON (B)(6) 2024. IT WAS FURTHER ADDED THAT THE PATIENT HAD THE PACEMAKER IMPLANTED ON (B)(6) 2024, BUT THEN HAD THE PACEMAKER REMOVED FROM THE BODY ON (B)(6) 2024, AND THE PATIENT WAS CONSULTED WITH PALLIATIVE CARE THEN DISCHARGED TO THE SKILLED NURSING/REHABILITATION FACILITY. IT WAS FURTHER REPORTED AND CORRECTED THAT THE ONSET DATE OF THE LEFT SIDED WEAKNESS WAS (B)(6) 2024, NOT (B)(6) 2024, AND THAT THE PATIENT HAD ADDITIONALLY ALSO EXPERIENCED A SEIZURE. THE EMERGENCY DEPARTMENT REVIEW OF SYSTEMS REVEALED POSITIVE FOR SEIZURES. THE PATIENT WAS NOT A CANDIDATE FOR TREATING WITH TENECTEPLASE (TNK) (AS THE PATIENT WAS RECENTLY ADMINISTERED TNK FOR THE PREVIOUS ISCHEMIC STROKE EXPERIENCED 185 DAYS POST INDEX PROCEDURE), SO WAS TREATED WITH IOHEXOL MEDICATION, INTRAVENOUS 0.9PERCENT NACL INJECTION, VASOPRESSORS AND MIDRODRINE. THE INITIAL NATIONAL INSITUTE OF HEALTH STROKE SCALE SCORE WAS 9.
(B)(4) STUDY. IT WAS REPORTED A STROKE OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 24MM WATCHMAN FLX PRO CLOSURE DEVICE WAS IMPLANTED WITH A COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 18.9 MM. THE PATIENT WAS DISCHARGED ON ASPIRIN AND WARFARIN. 167 DAYS POST INDEX PROCEDURE, THE PATIENT PRESENTED TO THE HOSPITAL FOR A T2 VERTEBRAL FRACTURE. AT THE TIME OF THE EVENT, THE PATIENT WAS ON ASPIRIN AND WARFARIN. BRAIN IMAGING AND COMPUTED TOMOGRAPHY (CT) WAS PERFORMED, ALONG WITH OTHER DIAGNOSTICS. THE PATIENT WAS ADMITTED TO THE HOSPITAL. 185 DAYS POST INDEX PROCEDURE, THE PATIENT UNDERWENT BRAIN IMAGING, CT IMAGING, MAGNETIC RESONANCE IMAGING (MRI), AND OTHER DIAGNOSTICS. THE PATIENT WAS DIAGNOSED WITH ISCHEMIC STROKE. THAT SAME DAY, THE EVENT WAS CONSIDERED RESOLVED WITH SEQUALAE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1983811 | WATCHMAN FLX? PRO | SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL | NGV | BOSTON SCIENTIFIC CORPORATION | M635WU60240 | 0032981020 | 00191506004590 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Male | Other| S| D| H |