LOTUS EDGE VALVE SYSTEM
Report
- Report Number
- 2134265-2019-09262
- Event Type
- Injury
- Date Received
- August 12, 2019
- Date of Event
- May 16, 2019
- Report Date
- January 28, 2020
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- NPT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
Narratives
UPDATES: B5:ON THE SAME DAY AS INDEX PROCEDURE, POST TAVR, ELECTROCARDIOGRAM REVEALED INCOMPLETE RIGHT BUNDLE BRANCH BLOCK. NO ACTION WAS TAKEN TO TREAT THE EVENT. THE NEXT DAY, THE EVENT WAS CONSIDERED AS RECOVERED AND THE SUBJECT WAS DISCHARGED ON ASPIRIN AND WARFARIN. B6: THE AORTIC VALVE AREA ACCORDING TO THE BASELINE TTE ((B)(6) 2019) WAS 0.87 CM^2. THE AORTIC VALVE AREA ACCORDING TO THE BASELINE TTE ((B)(6) 2019) WAS 0.87 CM^2. B7: CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD LEVEL-MILD)(TREATED WITH ORAL OR SYSTEMIC STEROID). H6: ARRHYTHMIA CODE ADDED.
PATIENT ID: CORRECTED FROM (B)(6) TO (B)(6). B5: UPDATED INITIAL REPORTER PHONE CORRECTED FROM(B)(6) TO (B)(6). INITIAL REPORTER ADDRESS (B)(4) CORRECTED FROM (B)(6) TO (B)(6).
REPRISE IV STUDY. PROCEDURE SUMMARY: PRIOR TO THE INDEX PROCEDURE, HEPARIN OR OTHER ANTICOAGULANT WAS GIVEN AND THE SUBJECT WAS ON A PRIOR REGIMEN OF ASPIRIN AT THE TIME OF INDEX PROCEDURE. THE SUBJECT RECEIVED LOADING DOSES 325 MG OF ASPIRIN AND 300 MG OF CLOPIDOGREL. A LOTUS INTRODUCER WAS PLACED AND THEN A 25 MM LOTUS EDGE VALVE (LOT#23098363) WAS INSERTED HOWEVER, WAS NOT IMPLANTED DUE TO WRONG VALVE SIZE. THEREFORE, THE 25 MM LOTUS EDGE VALVE (LOT#23098363) WAS EXCHANGED FOR A 27 MM LOTUS EDGE VALVE (LOT#23132213). SUCCESSFUL REPOSITIONING OF THE LOTUS EDGE VALVE INVOLVED PARTIAL RE-SHEATHING OF THE LOTUS EDGE VALVE IN THE DELIVERY SYSTEM CATHETER AND DEPLOYMENT INTO A MORE ACCURATE POSITION WITHIN THE AORTIC ANNULUS WHICH WAS DEPLOYED SUCCESSFULLY IN ACCORDANCE WITH THE DFU. EVENT SUMMARY: 48 DAYS OF POST INDEX PROCEDURE, DURING THE PROTOCOL SPECIFIED 30-DAY VISIT A 4D CT SCAN WAS PERFORMED WHICH REVEALED WELL SEATED PROSTHESIS HOWEVER JUST INFERIOR TO THE VALVULAR LEAFLETS UNDER THE RIGHT CORONARY CUSPS ALONG THE PROXIMAL ASPECT OF THE AORTIC VALVE PROSTHESIS AN ECCENTRIC LOW DENSITY REGION MEASURING 18 X 7 MM WAS NOTED WITH THE PRESENCE OF A NEW SUB 5-MM FILLING DEFECT WITHIN THE AORTIC ARCH SUGGESTIVE OF A THROMBUS RATHER THAN SUBPROSTHETIC PANNUS. AN ECHOCARDIOGRAM WAS PERFORMED WHICH REVEALED WELL SEATED PROSTHETIC AORTIC VALVE WITH NO OTHER ABNORMALITY.SUBJECT WAS DIAGNOSED WITH THICKENING OF THE LEAFLET DUE TO POSSIBLE THROMBUS. AT THE TIME OF THE EVENT, SUBJECT WAS ON ASPIRIN AND CLOPIDOGREL, HOWEVER CLOPIDOGREL WAS DISCONTINUED AND THE SUBJECT WAS STARTED ON COUMADIN. AT THE TIME OF REPORTING, THE EVENT WAS CONSIDERED AS RECOVERING. IT WAS FURTHER REPORTED THAT DURING THE IMPLANT PROCEDURE, THE INTRODUCER USED WAS AN ISLEEVE INTRODUCER, NOT A LOTUS INTRODUCER AS PREVIOUSLY REPORTED.
REPRISE IV STUDY. PROCEDURE SUMMARY: PRIOR TO THE INDEX PROCEDURE, HEPARIN OR OTHER ANTICOAGULANT WAS GIVEN AND THE SUBJECT WAS ON A PRIOR REGIMEN OF ASPIRIN AT THE TIME OF INDEX PROCEDURE. THE SUBJECT RECEIVED LOADING DOSES 325 MG OF ASPIRIN AND 300 MG OF CLOPIDOGREL. A LOTUS INTRODUCER WAS PLACED AND THEN A 25 MM LOTUS EDGE VALVE (LOT#23098363) WAS INSERTED HOWEVER, WAS NOT IMPLANTED DUE TO WRONG VALVE SIZE. THEREFORE, THE 25 MM LOTUS EDGE VALVE (LOT#23098363) WAS EXCHANGED FOR A 27 MM LOTUS EDGE VALVE (LOT#23132213). SUCCESSFUL REPOSITIONING OF THE LOTUS EDGE VALVE INVOLVED PARTIAL RE-SHEATHING OF THE LOTUS EDGE VALVE IN THE DELIVERY SYSTEM CATHETER AND DEPLOYMENT INTO A MORE ACCURATE POSITION WITHIN THE AORTIC ANNULUS WHICH WAS DEPLOYED SUCCESSFULLY IN ACCORDANCE WITH THE DFU. EVENT SUMMARY: 48 DAYS OF POST INDEX PROCEDURE, DURING THE PROTOCOL SPECIFIED 30-DAY VISIT A 4D CT SCAN WAS PERFORMED WHICH REVEALED WELL SEATED PROSTHESIS HOWEVER JUST INFERIOR TO THE VALVULAR LEAFLETS UNDER THE RIGHT CORONARY CUSPS ALONG THE PROXIMAL ASPECT OF THE AORTIC VALVE PROSTHESIS AN ECCENTRIC LOW DENSITY REGION MEASURING 18 X 7 MM WAS NOTED WITH THE PRESENCE OF A NEW SUB 5-MM FILLING DEFECT WITHIN THE AORTIC ARCH SUGGESTIVE OF A THROMBUS RATHER THAN SUBPROSTHETIC PANNUS. AN ECHOCARDIOGRAM WAS PERFORMED WHICH REVEALED WELL SEATED PROSTHETIC AORTIC VALVE WITH NO OTHER ABNORMALITY.SUBJECT WAS DIAGNOSED WITH THICKENING OF THE LEAFLET DUE TO POSSIBLE THROMBUS. AT THE TIME OF THE EVENT, SUBJECT WAS ON ASPIRIN AND CLOPIDOGREL, HOWEVER CLOPIDOGREL WAS DISCONTINUED AND THE SUBJECT WAS STARTED ON COUMADIN. AT THE TIME OF REPORTING, THE EVENT WAS CONSIDERED AS RECOVERING. IT WAS FURTHER REPORTED THAT: DURING THE IMPLANT PROCEDURE, THE INTRODUCER USED WAS AN ISLEEVE INTRODUCER, NOT A LOTUS INTRODUCER AS PREVIOUSLY REPORTED. ON THE SAME DAY AS INDEX PROCEDURE, POST TAVR, ELECTROCARDIOGRAM REVEALED INCOMPLETE RIGHT BUNDLE BRANCH BLOCK. NO ACTION WAS TAKEN TO TREAT THE EVENT. THE NEXT DAY, THE EVENT WAS CONSIDERED AS RECOVERED AND THE SUBJECT WAS DISCHARGED ON ASPIRIN AND WARFARIN.
REPRISE IV STUDY PROCEDURE SUMMARY: PRIOR TO THE INDEX PROCEDURE, HEPARIN OR OTHER ANTICOAGULANT WAS GIVEN AND THE SUBJECT WAS ON A PRIOR REGIMEN OF ASPIRIN AT THE TIME OF INDEX PROCEDURE. THE SUBJECT RECEIVED LOADING DOSES 325 MG OF ASPIRIN AND 300 MG OF CLOPIDOGREL. A LOTUS INTRODUCER WAS PLACED AND THEN A 25 MM LOTUS EDGE VALVE (LOT#23098363) WAS INSERTED HOWEVER, WAS NOT IMPLANTED DUE TO WRONG VALVE SIZE. THEREFORE, THE 25 MM LOTUS EDGE VALVE (LOT#23098363) WAS EXCHANGED FOR A 27 MM LOTUS EDGE VALVE (LOT#23132213). SUCCESSFUL REPOSITIONING OF THE LOTUS EDGE VALVE INVOLVED PARTIAL RE-SHEATHING OF THE LOTUS EDGE VALVE IN THE DELIVERY SYSTEM CATHETER AND DEPLOYMENT INTO A MORE ACCURATE POSITION WITHIN THE AORTIC ANNULUS WHICH WAS DEPLOYED SUCCESSFULLY IN ACCORDANCE WITH THE DFU. EVENT SUMMARY: 48 DAYS OF POST INDEX PROCEDURE, DURING THE PROTOCOL SPECIFIED 30-DAY VISIT A 4D CT SCAN WAS PERFORMED WHICH REVEALED WELL SEATED PROSTHESIS HOWEVER JUST INFERIOR TO THE VALVULAR LEAFLETS UNDER THE RIGHT CORONARY CUSPS ALONG THE PROXIMAL ASPECT OF THE AORTIC VALVE PROSTHESIS AN ECCENTRIC LOW DENSITY REGION MEASURING 18 X 7 MM WAS NOTED WITH THE PRESENCE OF A NEW SUB 5-MM FILLING DEFECT WITHIN THE AORTIC ARCH SUGGESTIVE OF A THROMBUS RATHER THAN SUBPROSTHETIC PANNUS. AN ECHOCARDIOGRAM WAS PERFORMED WHICH REVEALED WELL SEATED PROSTHETIC AORTIC VALVE WITH NO OTHER ABNORMALITY.SUBJECT WAS DIAGNOSED WITH THICKENING OF THE LEAFLET DUE TO POSSIBLE THROMBUS. AT THE TIME OF THE EVENT, SUBJECT WAS ON ASPIRIN AND CLOPIDOGREL, HOWEVER CLOPIDOGREL WAS DISCONTINUED AND THE SUBJECT WAS STARTED ON COUMADIN. AT THE TIME OF REPORTING, THE EVENT WAS CONSIDERED AS RECOVERING. IT WAS FURTHER REPORTED THAT: DURING THE IMPLANT PROCEDURE, THE INTRODUCER USED WAS AN ISLEEVE INTRODUCER, NOT A LOTUS INTRODUCER AS PREVIOUSLY REPORTED. ON THE SAME DAY AS INDEX PROCEDURE, POST TAVR, ELECTROCARDIOGRAM REVEALED INCOMPLETE RIGHT BUNDLE BRANCH BLOCK. NO ACTION WAS TAKEN TO TREAT THE EVENTS. THE NEXT DAY, THE EVENTS WERE CONSIDERED AS RECOVERED AND THE SUBJECT WAS DISCHARGED ON ASPIRIN AND WARFARIN. IT WAS FURTHER REPORTED THAT POST INDEX PROCEDURE, ELECTROCARDIOGRAM REVEALED LEFT ANTERIOR FASCULAR BLOCK. NO ACTION WAS TAKEN TO TREAT THE EVENTS.
(B)(6) STUDY. PROCEDURE SUMMARY: PRIOR TO THE INDEX PROCEDURE, HEPARIN OR OTHER ANTICOAGULANT WAS GIVEN AND THE SUBJECT WAS ON A PRIOR REGIMEN OF ASPIRIN AT THE TIME OF INDEX PROCEDURE. THE SUBJECT RECEIVED LOADING DOSES 325 MG OF ASPIRIN AND 300 MG OF CLOPIDOGREL. A LOTUS INTRODUCER WAS PLACED AND THEN A 25 MM LOTUS EDGE VALVE (LOT#23098363) WAS INSERTED HOWEVER, WAS NOT IMPLANTED DUE TO WRONG VALVE SIZE. THEREFORE, THE 25 MM LOTUS EDGE VALVE (LOT#23098363) WAS EXCHANGED FOR A 27 MM LOTUS EDGE VALVE (LOT#23132213). SUCCESSFUL REPOSITIONING OF THE LOTUS EDGE VALVE INVOLVED PARTIAL RE-SHEATHING OF THE LOTUS EDGE VALVE IN THE DELIVERY SYSTEM CATHETER AND DEPLOYMENT INTO A MORE ACCURATE POSITION WITHIN THE AORTIC ANNULUS WHICH WAS DEPLOYED SUCCESSFULLY IN ACCORDANCE WITH THE DFU. EVENT SUMMARY: 48 DAYS OF POST INDEX PROCEDURE, DURING THE PROTOCOL SPECIFIED 30-DAY VISIT A 4D CT SCAN WAS PERFORMED WHICH REVEALED WELL SEATED PROSTHESIS HOWEVER JUST INFERIOR TO THE VALVULAR LEAFLETS UNDER THE RIGHT CORONARY CUSPS ALONG THE PROXIMAL ASPECT OF THE AORTIC VALVE PROSTHESIS AN ECCENTRIC LOW DENSITY REGION MEASURING 18 X 7 MM WAS NOTED WITH THE PRESENCE OF A NEW SUB 5-MM FILLING DEFECT WITHIN THE AORTIC ARCH SUGGESTIVE OF A THROMBUS RATHER THAN SUBPROSTHETIC PANNUS. AN ECHOCARDIOGRAM WAS PERFORMED WHICH REVEALED WELL SEATED PROSTHETIC AORTIC VALVE WITH NO OTHER ABNORMALITY. SUBJECT WAS DIAGNOSED WITH THICKENING OF THE LEAFLET DUE TO POSSIBLE THROMBUS. AT THE TIME OF THE EVENT, SUBJECT WAS ON ASPIRIN AND CLOPIDOGREL, HOWEVER CLOPIDOGREL WAS DISCONTINUED AND THE SUBJECT WAS STARTED ON COUMADIN. AT THE TIME OF REPORTING, THE EVENT WAS CONSIDERED AS RECOVERING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 677122 | LOTUS EDGE VALVE SYSTEM | LOTUS EDGE TM VALVE SYSTEM 27 MM | NPT | BOSTON SCIENTIFIC CORPORATION | 10418 | 0023132213 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 89 YR | Required Intervention |