WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM
Report
- Report Number
- 2134265-2022-01249
- Event Type
- Injury
- Date Received
- February 8, 2022
- Date of Event
- January 13, 2022
- Report Date
- January 24, 2024
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- NGV
- UDI-DI
- 08714729860495
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
RELEVANT TESTS/LABORATORY DATA: UPDATED,
B5: DESCRIBE EVENT OR PROBLEM - UPDATED TO ACCOUNT FOR ADDITIONAL NARRATIVE. D3: MANUFACTURER ADDRESS 1, MANUFACTURER CITY, MANUFACTURER ZIP/POSTAL CODE - UPDATED G1: MFR CONTACT FIRST NAME, MFR CONTACT LAST NAME, MFR CONTACT ADDRESS 1, MFR CONTACT CITY, MFR CONTACT ZIP/POSTAL CODE, MFR CONTACT PHONE NUMBER, MFR CONTACT EMAIL - UPDATED H6: IMPACT CODES- UPDATED TO ADD A HOSPITALIZATION CODE.
(B)(6) STUDY. IT WAS REPORTED THAT STROKE OCCURRED. PROCEDURE SUMMARY: ON (B)(6) 2021, A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED. PRIOR TO THE INDEX PROCEDURE, ASPIRIN WAS NOT ADMINISTERED. SUCCESSFUL PLACEMENT WAS COMPLETED OF A 24 MM WATCHMAN FLX LAA CLOSURE DEVICE WITH COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 20 MM. POST PROCEDURE APIXABAN WAS CONTINUED. ONE DAY POST INDEX PROCEDURE THE SUBJECT WAS DISCHARGED. POST PROCEDURE EVENT SUMMARY: ON (B)(6) 2022, 234 DAYS POST INDEX PROCEDURE, THE SUBJECT PRESENTED EMERGENTLY WITH LEFT EYE VISION LOSS, LEFT-SIDED WEAKNESS AND NUMBNESS. THE SUBJECT REPORTED THAT THE LEFT EYE GOT BLURRY WHILE WATCHING TELEVISION IN THE MORNING AND LOST COMPLETE VISION SHORTLY AFTERWARDS. THE SUBJECT ALSO NOTICED NUMBNESS IN THE RIGHT CORNER OF THE MOUTH AND FELT OFF BALANCE AND THE WIFE NOTED THAT THE SUBJECTS WALKING WAS IMPAIRED. OF NOTE, THE SUBJECT WAS NORMAL AFTER WAKING UP IN THE MORNING AND TOOK SHOWER AND GOT READY WITHOUT ANY DIFFICULTY. THE SUBJECT DENIED HEADACHE HOWEVER COMPLAINED OF ON AND OFF BLURRED VISION IN THE LEFT EYE OFF FOR THE PAST 2 MONTHS WITH THAT DAY BEING THE WORST. PHYSICAL EXAMINATION REVEALED DIZZINESS AND NUMBNESS ALONG WITH IMPROVING LEFT VISUAL LOSS. THE GLASGOW COMA SCALE (GCS) EYE, VERBAL AND MOTOR SUBSCORES WERE 4, 5 AND 6 RESPECTIVELY. COMPUTERIZED TOMOGRAPHY (CT) ANGIOGRAM OF THE HEAD/NECK REVEALED NO EVIDENCE OF HEMODYNAMICALLY SIGNIFICANT STENOSIS INVOLVING THE CAROTID OR VERTEBRAL ARTERIAL SYSTEMS. CT OF THE HEAD/BRAIN WITHOUT CONTRAST REVEALED NO ACUTE INTRACRANIAL ABNORMALITY. NONSPECIFIC WHITE MATTER ABNORMALITIES WERE OBSERVED, WHICH MOST LIKELY REPRESENT MILD CHRONIC MICROVASCULAR ISCHEMIC CHANGES, TAKING INTO CONSIDERATION THE SUBJECTS AGE. NEUROLOGY WAS CONSULTED AND TENECTEPLASE (TNK) WAS RECOMMENDED. NEUROLOGICAL EXAMINATION REVEALED THE SUBJECT TO BE AWAKE, ALERT AND FULLY ORIENTED. THE SUBJECT WAS ABLE TO ANSWER QUESTIONS AND FOLLOW REQUESTS APPROPRIATELY. THERE WAS NO EVIDENCE OF APHASIA OR DYSARTHRIA. LEFT EYE WAS MARKEDLY IMPAIRED, AND FUNDI WERE NOT VISUALIZED. THE SUBJECTS VISION HAD IMPROVED BUT REMAINED IMPAIRED. THE SUBJECT WAS ALSO NOTED WITH LEFT SIDED NUMBNESS AND WEAKNESS. THE SUBJECT WAS DIAGNOSED WITH ACUTE CEREBROVASCULAR ACCIDENT AND WAS HOSPITALIZED; STATIN WAS INITIATED. ALTHOUGH THE VISION WAS IMPROVING, THE SUBJECT CONTINUED TO HAVE NONFUNCTIONAL IMPAIRMENT BOTH VISUALLY AND WITH THE LEFT SIDE. RIGHT OCCIPITAL INFARCT WAS SUSPECTED. THE ETIOLOGY OF THE STROKE WAS ISCHEMIC. AT THE TIME OF EVENT, THE SUBJECT WAS NOT ON ANY ANTIPLATELET/ANTICOAGULANT MEDICATIONS. ON THE SAME DAY, THE SUBJECT WAS GIVEN THROMBOLYTIC WITHOUT COMPLICATION. ON (B)(6) 2022, THE HIGHEST MEND (MIAMI EMERGENCY NEUROLOGIC DEFICIT) SCORE WAS 3 AND NIHSS SCORE WAS 4. ON (B)(6) 2022, MAGNETIC RESONANCE IMAGING M(RI) OF BRAIN WITHOUT CONTRAST REVEALED NO ACUTE PATHOLOGY. MILD CHRONIC ISCHEMIC MICROVASCULAR DISEASE WAS NOTED. THE SUBJECT WAS INITIATED ON ASPIRIN (81 MG). ON (B)(6) 2022, THE SUBJECT HAD TOTAL BLINDNESS OF THE LEFT EYE AT NIGHT WITHOUT ANY PAIN. THE SUBJECT WAS THEN GIVEN A BOLUS OF SALINE AND SOLU-MEDROL PULSE WHICH IMPROVED THE VISION. ON (B)(6) 2022, THE HIGHEST NIHSS SCORE WAS 4 . ON NEUROLOGY EXAMINATION, MONOCULAR VISUAL FIELD SHOWED A CENTRAL SCOTOMA WITH AN ISLAND OF PRESERVED VISION ONLY IN THE SUPERIOR TEMPORAL QUADRANT. THE SUBJECT HAD FULL OCULAR MOVEMENTS WITHOUT PTOSIS OR ANISOCORIA. CT OF THE HEAD AND BRAIN REVEALED QUESTIONABLE LOW DENSITY IN THE POSTERIOR LEFT OCCIPITAL GRAY-WHITE MATTER JUNCTION. PARENCHYMAL ATROPHY WITH CHRONIC ISCHEMIC SMALL VESSEL CHANGES IN THE PERIVENTRICULAR WHITE MATTER WAS NOTED. MRI OF THE BRAIN REVEALED NO ACUTE ABNORMALITY OR INFARCTS. MILD CHRONIC WHITE MATTER ISCHEMIC CHANGES WERE NOTED. THE SUBJECT WAS CONSIDERED FOR DISCHARGE AND WAS RECOMMENDED TO VISIT AN OPHTHALMOLOGIST. THE DOSE OF ASPIRIN WAS INCREASED FROM 81 MG TO 325 MG. AT THE TIME OF REPORTING, THE EVENT WAS ONGOING. ON (B)(6) 2022, THE SUBJECT WAS DISCHARGED ON ASPIRIN. ON (B)(6) 2022, THE MRS SCORE WAS 1- NOT SIGNIFICANT.
OPTION STUDY. IT WAS REPORTED THAT STROKE OCCURRED. PROCEDURE SUMMARY: ON (B)(6) 2021, A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED. PRIOR TO THE INDEX PROCEDURE, ASPIRIN WAS NOT ADMINISTERED. SUCCESSFUL PLACEMENT WAS COMPLETED OF A 24 MM WATCHMAN FLX LAA CLOSURE DEVICE WITH COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 20 MM. POST PROCEDURE APIXABAN WAS CONTINUED. ONE DAY POST INDEX PROCEDURE THE SUBJECT WAS DISCHARGED. POST PROCEDURE EVENT SUMMARY: ON 13-JAN-2022, 234 DAYS POST INDEX PROCEDURE, THE SUBJECT PRESENTED EMERGENTLY WITH LEFT EYE VISION LOSS, LEFT-SIDED WEAKNESS AND NUMBNESS. THE SUBJECT REPORTED THAT THE LEFT EYE GOT BLURRY WHILE WATCHING TELEVISION IN THE MORNING AND LOST COMPLETE VISION SHORTLY AFTERWARDS. THE SUBJECT ALSO NOTICED NUMBNESS IN THE RIGHT CORNER OF THE MOUTH AND FELT OFF BALANCE AND THE WIFE NOTED THAT THE SUBJECTS WALKING WAS IMPAIRED. OF NOTE, THE SUBJECT WAS NORMAL AFTER WAKING UP IN THE MORNING AND TOOK SHOWER AND GOT READY WITHOUT ANY DIFFICULTY. THE SUBJECT DENIED HEADACHE HOWEVER COMPLAINED OF ON AND OFF BLURRED VISION IN THE LEFT EYE OFF FOR THE PAST 2 MONTHS WITH THAT DAY BEING THE WORST. PHYSICAL EXAMINATION REVEALED DIZZINESS AND NUMBNESS ALONG WITH IMPROVING LEFT VISUAL LOSS. THE GLASGOW COMA SCALE (GCS) EYE, VERBAL AND MOTOR SUBSCORES WERE 4, 5 AND 6 RESPECTIVELY. COMPUTERIZED TOMOGRAPHY (CT) ANGIOGRAM OF THE HEAD/NECK REVEALED NO EVIDENCE OF HEMODYNAMICALLY SIGNIFICANT STENOSIS INVOLVING THE CAROTID OR VERTEBRAL ARTERIAL SYSTEMS. CT OF THE HEAD/BRAIN WITHOUT CONTRAST REVEALED NO ACUTE INTRACRANIAL ABNORMALITY. NONSPECIFIC WHITE MATTER ABNORMALITIES WERE OBSERVED, WHICH MOST LIKELY REPRESENT MILD CHRONIC MICROVASCULAR ISCHEMIC CHANGES, TAKING INTO CONSIDERATION THE SUBJECTS AGE. NEUROLOGY WAS CONSULTED AND TENECTEPLASE (TNK) WAS RECOMMENDED. NEUROLOGICAL EXAMINATION REVEALED THE SUBJECT TO BE AWAKE, ALERT AND FULLY ORIENTED. THE SUBJECT WAS ABLE TO ANSWER QUESTIONS AND FOLLOW REQUESTS APPROPRIATELY. THERE WAS NO EVIDENCE OF APHASIA OR DYSARTHRIA. LEFT EYE WAS MARKEDLY IMPAIRED, AND FUNDI WERE NOT VISUALIZED. THE SUBJECTS VISION HAD IMPROVED BUT REMAINED IMPAIRED. THE SUBJECT WAS ALSO NOTED WITH LEFT SIDED NUMBNESS AND WEAKNESS. THE SUBJECT WAS DIAGNOSED WITH ACUTE CEREBROVASCULAR ACCIDENT AND WAS HOSPITALIZED; STATIN WAS INITIATED. ALTHOUGH THE VISION WAS IMPROVING, THE SUBJECT CONTINUED TO HAVE NONFUNCTIONAL IMPAIRMENT BOTH VISUALLY AND WITH THE LEFT SIDE. RIGHT OCCIPITAL INFARCT WAS SUSPECTED. THE ETIOLOGY OF THE STROKE WAS ISCHEMIC. AT THE TIME OF EVENT, THE SUBJECT WAS NOT ON ANY ANTIPLATELET/ANTICOAGULANT MEDICATIONS. ON THE SAME DAY, THE SUBJECT WAS GIVEN THROMBOLYTIC WITHOUT COMPLICATION. ON 13-JAN-2022, THE HIGHEST MEND (MIAMI EMERGENCY NEUROLOGIC DEFICIT) SCORE WAS 3 AND NIHSS SCORE WAS 4. ON (B)(6) 2022, MAGNETIC RESONANCE IMAGING M(RI) OF BRAIN WITHOUT CONTRAST REVEALED NO ACUTE PATHOLOGY. MILD CHRONIC ISCHEMIC MICROVASCULAR DISEASE WAS NOTED. THE SUBJECT WAS INITIATED ON ASPIRIN (81 MG). ON (B)(6) 2022, THE SUBJECT HAD TOTAL BLINDNESS OF THE LEFT EYE AT NIGHT WITHOUT ANY PAIN. THE SUBJECT WAS THEN GIVEN A BOLUS OF SALINE AND SOLU-MEDROL PULSE WHICH IMPROVED THE VISION. ON (B)(6) 2022, THE HIGHEST NIHSS SCORE WAS 4 . ON NEUROLOGY EXAMINATION, MONOCULAR VISUAL FIELD SHOWED A CENTRAL SCOTOMA WITH AN ISLAND OF PRESERVED VISION ONLY IN THE SUPERIOR TEMPORAL QUADRANT. THE SUBJECT HAD FULL OCULAR MOVEMENTS WITHOUT PTOSIS OR ANISOCORIA. CT OF THE HEAD AND BRAIN REVEALED QUESTIONABLE LOW DENSITY IN THE POSTERIOR LEFT OCCIPITAL GRAY-WHITE MATTER JUNCTION. PARENCHYMAL ATROPHY WITH CHRONIC ISCHEMIC SMALL VESSEL CHANGES IN THE PERIVENTRICULAR WHITE MATTER WAS NOTED. MRI OF THE BRAIN REVEALED NO ACUTE ABNORMALITY OR INFARCTS. MILD CHRONIC WHITE MATTER ISCHEMIC CHANGES WERE NOTED. THE SUBJECT WAS CONSIDERED FOR DISCHARGE AND WAS RECOMMENDED TO VISIT AN OPHTHALMOLOGIST. THE DOSE OF ASPIRIN WAS INCREASED FROM 81 MG TO 325 MG. AT THE TIME OF REPORTING, THE EVENT WAS ONGOING. ON (B)(6) 2022, THE SUBJECT WAS DISCHARGED ON ASPIRIN. ON (B)(6) 2022, THE MRS SCORE WAS 1- NOT SIGNIFICANT.
OPTION STUDY IT WAS REPORTED THAT STROKE OCCURRED. PROCEDURE SUMMARY: ON (B)(6) 2021, A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED. PRIOR TO THE INDEX PROCEDURE, ASPIRIN WAS NOT ADMINISTERED. SUCCESSFUL PLACEMENT WAS COMPLETED OF A 24 MM WATCHMAN FLX LAA CLOSURE DEVICE WITH COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 20 MM. POST PROCEDURE APIXABAN WAS CONTINUED. ONE DAY POST INDEX PROCEDURE THE SUBJECT WAS DISCHARGED. POST PROCEDURE EVENT SUMMARY: ON (B)6) 2022, 234 DAYS POST INDEX PROCEDURE, THE SUBJECT PRESENTED EMERGENTLY WITH LEFT EYE VISION LOSS, LEFT-SIDED WEAKNESS AND NUMBNESS. THE SUBJECT REPORTED THAT THE LEFT EYE GOT BLURRY WHILE WATCHING TELEVISION IN THE MORNING AND LOST COMPLETE VISION SHORTLY AFTERWARDS. THE SUBJECT ALSO NOTICED NUMBNESS IN THE RIGHT CORNER OF THE MOUTH AND FELT OFF BALANCE AND THE WIFE NOTED THAT THE SUBJECTS WALKING WAS IMPAIRED. OF NOTE, THE SUBJECT WAS NORMAL AFTER WAKING UP IN THE MORNING AND TOOK SHOWER AND GOT READY WITHOUT ANY DIFFICULTY. THE SUBJECT DENIED HEADACHE HOWEVER COMPLAINED OF ON AND OFF BLURRED VISION IN THE LEFT EYE OFF FOR THE PAST 2 MONTHS WITH THAT DAY BEING THE WORST. PHYSICAL EXAMINATION REVEALED DIZZINESS AND NUMBNESS ALONG WITH IMPROVING LEFT VISUAL LOSS. THE GLASGOW COMA SCALE (GCS) EYE, VERBAL AND MOTOR SUBSCORES WERE 4, 5 AND 6 RESPECTIVELY. COMPUTERIZED TOMOGRAPHY (CT) ANGIOGRAM OF THE HEAD/NECK REVEALED NO EVIDENCE OF HEMODYNAMICALLY SIGNIFICANT STENOSIS INVOLVING THE CAROTID OR VERTEBRAL ARTERIAL SYSTEMS. CT OF THE HEAD/BRAIN WITHOUT CONTRAST REVEALED NO ACUTE INTRACRANIAL ABNORMALITY. NONSPECIFIC WHITE MATTER ABNORMALITIES WERE OBSERVED, WHICH MOST LIKELY REPRESENT MILD CHRONIC MICROVASCULAR ISCHEMIC CHANGES, TAKING INTO CONSIDERATION THE SUBJECTS AGE. NEUROLOGY WAS CONSULTED AND TENECTEPLASE (TNK) WAS RECOMMENDED. NEUROLOGICAL EXAMINATION REVEALED THE SUBJECT TO BE AWAKE, ALERT AND FULLY ORIENTED. THE SUBJECT WAS ABLE TO ANSWER QUESTIONS AND FOLLOW REQUESTS APPROPRIATELY. THERE WAS NO EVIDENCE OF APHASIA OR DYSARTHRIA. LEFT EYE WAS MARKEDLY IMPAIRED, AND FUNDI WERE NOT VISUALIZED. THE SUBJECTS VISION HAD IMPROVED BUT REMAINED IMPAIRED. THE SUBJECT WAS ALSO NOTED WITH LEFT SIDED NUMBNESS AND WEAKNESS. THE SUBJECT WAS DIAGNOSED WITH ACUTE CEREBROVASCULAR ACCIDENT AND WAS HOSPITALIZED; STATIN WAS INITIATED. ALTHOUGH THE VISION WAS IMPROVING, THE SUBJECT CONTINUED TO HAVE NONFUNCTIONAL IMPAIRMENT BOTH VISUALLY AND WITH THE LEFT SIDE. RIGHT OCCIPITAL INFARCT WAS SUSPECTED. THE ETIOLOGY OF THE STROKE WAS ISCHEMIC. AT THE TIME OF EVENT, THE SUBJECT WAS NOT ON ANY ANTIPLATELET/ANTICOAGULANT MEDICATIONS. ON THE SAME DAY, THE SUBJECT WAS GIVEN THROMBOLYTIC WITHOUT COMPLICATION. ON (B)(6) 2022, THE HIGHEST MEND (MIAMI EMERGENCY NEUROLOGIC DEFICIT) SCORE WAS 3 AND NIHSS SCORE WAS 4. ON (B)(6) 2022, MAGNETIC RESONANCE IMAGING M(RI) OF BRAIN WITHOUT CONTRAST REVEALED NO ACUTE PATHOLOGY. MILD CHRONIC ISCHEMIC MICROVASCULAR DISEASE WAS NOTED. THE SUBJECT WAS INITIATED ON ASPIRIN (81 MG). ON (B)(6) 2022, THE SUBJECT HAD TOTAL BLINDNESS OF THE LEFT EYE AT NIGHT WITHOUT ANY PAIN. THE SUBJECT WAS THEN GIVEN A BOLUS OF SALINE AND SOLU-MEDROL PULSE WHICH IMPROVED THE VISION. ON (B)(6) 2022, THE HIGHEST NIHSS SCORE WAS 4 . ON NEUROLOGY EXAMINATION, MONOCULAR VISUAL FIELD SHOWED A CENTRAL SCOTOMA WITH AN ISLAND OF PRESERVED VISION ONLY IN THE SUPERIOR TEMPORAL QUADRANT. THE SUBJECT HAD FULL OCULAR MOVEMENTS WITHOUT PTOSIS OR ANISOCORIA. CT OF THE HEAD AND BRAIN REVEALED QUESTIONABLE LOW DENSITY IN THE POSTERIOR LEFT OCCIPITAL GRAY-WHITE MATTER JUNCTION. PARENCHYMAL ATROPHY WITH CHRONIC ISCHEMIC SMALL VESSEL CHANGES IN THE PERIVENTRICULAR WHITE MATTER WAS NOTED. MRI OF THE BRAIN REVEALED NO ACUTE ABNORMALITY OR INFARCTS. MILD CHRONIC WHITE MATTER ISCHEMIC CHANGES WERE NOTED. THE SUBJECT WAS CONSIDERED FOR DISCHARGE AND WAS RECOMMENDED TO VISIT AN OPHTHALMOLOGIST. THE DOSE OF ASPIRIN WAS INCREASED FROM 81 MG TO 325 MG. AT THE TIME OF REPORTING, THE EVENT WAS ONGOING. ON (B)(6) 2022, THE SUBJECT WAS DISCHARGED ON ASPIRIN. ON (B)(6) 2022, THE MRS SCORE WAS 1- NOT SIGNIFICANT. IT WAS FURTHER REPORTED THAT DURING THIS TIME, THE LAB REVEALED AN INTERNAL NORMALIZED RATIO (INR) OF 1.1 SECONDS. ON THE SAME DAY, THE PATIENT WAS HOSPITALIZED TO THE NEUROLOGY INTENSIVE CARE UNIT (ICU) FOR FURTHER EVALUATION AND TREATMENT. THE PATIENT WAS A GOOD CANDIDATE OF TISSUE PLASMINOGEN ACTIVATOR (TPA) AND WAS GIVEN TPA ON THE SAME DAY WITHOUT COMPLICATION. PHYSICAL, OCCUPATIONAL AND SPEECH THERAPIES WERE CONSULTED. ON (B)(6) 2022, REPEAT CT OF THE HEAD AND BRAIN WITHOUT CONTRAST ADDITIONALLY REVEALED ACUTE ISCHEMIC OPTIC NEUROPATHY OF THE LEFT EYE. ON (B)(6) 2022, THE STROKE EVENT WAS CONSIDERED RESOLVED WITH RESIDUAL EFFECTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 903319 | WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM | SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL | NGV | BOSTON SCIENTIFIC CORPORATION | 10390 | 0026601062 | 08714729860495 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Male | Required Intervention |