WATCHMAN FLX? PRO
Report
- Report Number
- 2124215-2024-58324
- Event Type
- Injury
- Date Received
- September 20, 2024
- Date of Event
- August 31, 2024
- Report Date
- March 31, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- NGV
- UDI-DI
- 00191506004613
- PMA / PMN Number
- P130013
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
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 MYOCARDIAL INFARCTION AND CHEST PAIN. 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 # M635WU60310 BATCH # 0034025082. 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 CEREBRAL VASCULAR ACCIDENT (CVA), MYOCARDIAL INFARCTION, AND CHEST PAIN/DISCOMFORT (HOSPITALIZATION, MEDICATION REQUIRED). RISK REVIEW: A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE EVENTS OF CEREBRAL VASCULAR ACCIDENT (CVA), MYOCARDIAL INFARCTION, AND CHEST PAIN/DISCOMFORT 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: 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 THE PATIENT EXPERIENCED A CEREBRAL VASCULAR ACCIDENT. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN ACCESS SYSTEM (WAS) AND A 31MM WATCHMAN FLX PRO LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE SELECTED TO BE USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE CLOSURE DEVICE IMPLANTED IN THE LAA OF THE PATIENT WITH A COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 26 MM. THERE WERE NO PATIENT COMPLICATIONS THAT WERE REPORTED TO HAVE OCCURRED. THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. TWENTY-FOUR (24) DAYS POST INDEX PROCEDURE, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH STROKE-LIKE SYMPTOMS AND CHEST PAIN. ANGIOGRAPHY WITHOUT REVASCULARIZATION, COMPUTED TOMOGRAPHY (CT) SCAN, DIAGNOSTIC CATHETERIZATION, ECHOCARDIOGRAM, AND X-RAY WAS PERFORMED AS DIAGNOSTICS FOR THE EVENT. THE PATIENT WAS DIAGNOSED WITH NON-ST-ELEVATION MYOCARDIAL INFARCTION (NSTEMI). THE PATIENT'S MEDICATION REGIMENT WAS ADJUSTED AS A RESULT OF THIS EVENT. THE PATIENT WAS RECOMMENDED TO DISCHARGE HOME ONLY ON LOW DOSE OF ELIQUIS, AND TO STOP ASPIRIN AND PLAVIX. THREE (3) DAYS LATER THE PATIENT WAS DISCHARGED. THIRTY-FIVE (35) DAYS POST PROCEDURE THE PATIENT PRESENTED TO THE EMERGENCY ROOM DUE TO BACK PAIN AND BLACK TARRY STOOLS. LAB TESTS WERE PERFORMED, AND THE PATIENT WAS DIAGNOSED WITH BACTEREMIA. THE PATIENT WAS HOSPITALIZED FOR FURTHER EVALUATION AND TREATMENT. CT SCAN WAS PERFORMED FOR THE BACK PAIN, WHICH REVEALED MULTILEVEL DEGENERATIVE CHANGES OF THE LUMBAR SPINE. TWO (2) DAYS LATER, THE PATIENT'S MENTAL STATUS OVERALL WAS LETHARGIC. CT OF THE PATIENT'S HEAD WAS PERFORMED, WHICH REVEALED NO ACUTE INTRACRANIAL ABNORMALITY. SMALL SUBACUTE INFARCT LEFT SPLENIUM, AND NO HEMORRHAGIC CONVERSION. THE PATIENT WAS INITIATED ON IV KEPPRA FOR SUSPECTED FOCAL SEIZURES WITH IMPROVEMENT IN SYMPTOMS. THIRTY-EIGHT (38) DAYS POST PROCEDURE, THE PATIENT HAD SOME RIGHT SHOULDER MOVEMENT THAT APPEARED TO BE INVOLUNTARY WHICH WAS CONCERNING FOR SEIZURE-LIKE ACTIVITY. MRI OF THE CERVICAL SPINE SHOWED DIFFUSE HETEROGENEOUS BONE MARROW SIGNAL INTENSITY OF UNCERTAIN ETIOLOGY. POSTERIOR DISC OSTEOPHYTE COMPLEX WITH MINIMAL FLATTENING OF ANTERIOR THECAL SAC AT C3-4. NO HIGH-GRADE CENTRAL CANAL OR NEURAL FORAMINAL NARROWING. NO ACUTE FRACTURE. MRI OF THE LUMBAR SPINE SHOWED CONVEX LEFT SCOLIOTIC CURVATURE LUMBAR SPINE WITH MULTILEVEL DEGENERATIVE DISC CHANGES AS ABOVE. HETEROGENEOUS BONE MARROW SIGNAL INTENSITY IS PRESENT UNCHANGED, NONSPECIFIC FLUID SIGNAL INTENSITY IN THE DISC SPACES AT L2-3, L3-4, AND L4-5. THERE IS NO ASSOCIATED ENDPLATE DESTRUCTION OR SIGNAL ABNORMALITY. ON THE SAME DAY, MRI HEAD WAS PERFORMED, WHICH REVEALED SCATTERED AREAS OF RESTRICTED DIFFUSION INVOLVING BOTH CEREBRAL HEMISPHERES, THE CEREBELLUM, AND CORPUSCULUM MOST CONSISTENT WITH AREAS OF ACUTE TO SUBACUTE INFARCT. GIVEN THE INVOLVEMENT OF MULTIPLE VASCULAR TERRITORIES THIS SUGGEST AN EMBOLIC PROCESS, SCATTERED SMALL AREAS OF ENHANCEMENT INCLUDING THE LEFT BASAL GANGLIA, RIGHT THALAMUS, AND LEFT FRONTAL CORTEX, THESE AREAS OF ENHANCEMENT ARE NONSPECIFIC AND COULD REFLECT ENHANCEMENT OF SUBACUTE INFARCTS. THE PATIENT WAS STARTED ON 24-HOUR EEG AND BEGAN KEPPRA 500 MG IVP TWICE DAILY. FORTY (40) DAYS LATER THE REPEAT MRI WAS PERFORMED WHICH REVEALED SMALL SUBACUTE INFARCT LEFT SPLENIUM WITH NO HEMORRHAGIC CONVERSION. THE PATIENT WAS DIAGNOSED WITH HAVING A CEREBRAL VASCULAR ACCIDENT. THE PATIENT REMAINS HOSPITALIZED FOR THESE EVENTS.
HEAL-LAA STUDY. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A CEREBRAL VASCULAR ACCIDENT. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS BEING PERFORMED. A WATCHMAN ACCESS SYSTEM (WAS) AND A 31MM WATCHMAN FLX PRO LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE SELECTED TO BE USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE CLOSURE DEVICE IMPLANTED IN THE LAA OF THE PATIENT WITH A COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 26 MM. THERE WERE NO PATIENT COMPLICATIONS THAT WERE REPORTED TO HAVE OCCURRED. THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. TWENTY-FOUR (24) DAYS POST INDEX PROCEDURE, THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH STROKE-LIKE SYMPTOMS AND CHEST PAIN. ANGIOGRAPHY WITHOUT REVASCULARIZATION, COMPUTED TOMOGRAPHY (CT) SCAN, DIAGNOSTIC CATHETERIZATION, ECHOCARDIOGRAM, AND X-RAY WAS PERFORMED AS DIAGNOSTICS FOR THE EVENT. THE PATIENT WAS DIAGNOSED WITH NON-ST-ELEVATION MYOCARDIAL INFARCTION (NSTEMI). THE PATIENT'S MEDICATION REGIMENT WAS ADJUSTED AS A RESULT OF THIS EVENT. THE PATIENT WAS RECOMMENDED TO DISCHARGE HOME ONLY ON LOW DOSE OF ELIQUIS, AND TO STOP ASPIRIN AND PLAVIX. THREE (3) DAYS LATER THE PATIENT WAS DISCHARGED. THIRTY-FIVE (35) DAYS POST PROCEDURE THE PATIENT PRESENTED TO THE EMERGENCY ROOM DUE TO BACK PAIN AND BLACK TARRY STOOLS. LAB TESTS WERE PERFORMED, AND THE PATIENT WAS DIAGNOSED WITH BACTEREMIA. THE PATIENT WAS HOSPITALIZED FOR FURTHER EVALUATION AND TREATMENT. CT SCAN WAS PERFORMED FOR THE BACK PAIN, WHICH REVEALED MULTILEVEL DEGENERATIVE CHANGES OF THE LUMBAR SPINE. TWO (2) DAYS LATER, THE PATIENT'S MENTAL STATUS OVERALL WAS LETHARGIC. CT OF THE PATIENT'S HEAD WAS PERFORMED, WHICH REVEALED NO ACUTE INTRACRANIAL ABNORMALITY. SMALL SUBACUTE INFARCT LEFT SPLENIUM, AND NO HEMORRHAGIC CONVERSION. THE PATIENT WAS INITIATED ON IV KEPPRA FOR SUSPECTED FOCAL SEIZURES WITH IMPROVEMENT IN SYMPTOMS. THIRTY-EIGHT (38) DAYS POST PROCEDURE, THE PATIENT HAD SOME RIGHT SHOULDER MOVEMENT THAT APPEARED TO BE INVOLUNTARY WHICH WAS CONCERNING FOR SEIZURE-LIKE ACTIVITY. MRI OF THE CERVICAL SPINE SHOWED DIFFUSE HETEROGENEOUS BONE MARROW SIGNAL INTENSITY OF UNCERTAIN ETIOLOGY. POSTERIOR DISC OSTEOPHYTE COMPLEX WITH MINIMAL FLATTENING OF ANTERIOR THECAL SAC AT C3-4. NO HIGH-GRADE CENTRAL CANAL OR NEURAL FORAMINAL NARROWING. NO ACUTE FRACTURE. MRI OF THE LUMBAR SPINE SHOWED CONVEX LEFT SCOLIOTIC CURVATURE LUMBAR SPINE WITH MULTILEVEL DEGENERATIVE DISC CHANGES AS ABOVE. HETEROGENEOUS BONE MARROW SIGNAL INTENSITY IS PRESENT UNCHANGED, NONSPECIFIC FLUID SIGNAL INTENSITY IN THE DISC SPACES AT L2-3, L3-4, AND L4-5. THERE IS NO ASSOCIATED ENDPLATE DESTRUCTION OR SIGNAL ABNORMALITY. ON THE SAME DAY, MRI HEAD WAS PERFORMED, WHICH REVEALED SCATTERED AREAS OF RESTRICTED DIFFUSION INVOLVING BOTH CEREBRAL HEMISPHERES, THE CEREBELLUM, AND CORPUSCULUM MOST CONSISTENT WITH AREAS OF ACUTE TO SUBACUTE INFARCT. GIVEN THE INVOLVEMENT OF MULTIPLE VASCULAR TERRITORIES THIS SUGGEST AN EMBOLIC PROCESS, SCATTERED SMALL AREAS OF ENHANCEMENT INCLUDING THE LEFT BASAL GANGLIA, RIGHT THALAMUS, AND LEFT FRONTAL CORTEX, THESE AREAS OF ENHANCEMENT ARE NONSPECIFIC AND COULD REFLECT ENHANCEMENT OF SUBACUTE INFARCTS. THE PATIENT WAS STARTED ON 24-HOUR EEG AND BEGAN KEPPRA 500 MG IVP TWICE DAILY. FORTY (40) DAYS LATER THE REPEAT MRI WAS PERFORMED WHICH REVEALED SMALL SUBACUTE INFARCT LEFT SPLENIUM WITH NO HEMORRHAGIC CONVERSION. THE PATIENT WAS DIAGNOSED WITH HAVING A CEREBRAL VASCULAR ACCIDENT. THE PATIENT REMAINS HOSPITALIZED FOR THESE EVENTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 436790 | WATCHMAN FLX? PRO | SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL | NGV | BOSTON SCIENTIFIC CORPORATION | M635WU60310 | 0034025082 | 00191506004613 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Female | Required Intervention |