SYNERGY
Report
- Report Number
- 2124215-2023-04382
- Event Type
- Injury
- Date Received
- February 8, 2023
- Date of Event
- January 17, 2022
- Report Date
- June 21, 2024
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- NIQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
INITIAL REPORTER FACILITY NAME: (B)(6).
E1 - INITIAL REPORTER FACILITY NAME: (B)(6) UNIVERSITY.
E1 - INITIAL REPORTER FACILITY NAME: (B)(6).
SYNERGY CHINA REGISTRY. IT WAS REPORTED THAT CORONARY ATHEROSCLEROTIC HEART DISEASE OCCURRED. IN (B)(6) 2020, THE SUBJECT INDEX PROCEDURE WAS PERFORMED. THE TARGET LESION 1 WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) EXTENDING UP TO MIDDLE RCA WITH 99% STENOSIS AND WAS 54 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.5 MM. THE TARGET LESION 1 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.00 MM X 32 MM OVERLAPPED ON TO 3.50 MM X 28 MM SYNERGY STENT SYSTEMS. FOLLOWING POST-DILATATION, THE RESIDUAL STENOSIS WAS 0%. IN (B)(6) 2020, STAGED PROCEDURE WAS PERFORMED AND THE TARGET LESION 1 WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) EXTENDING UP TO MIDDLE LAD WITH 90% STENOSIS AND WAS 66 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.75 MM. THE TARGET LESION 1 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.50 MM X 38 MM OVERLAPPED ON TO 2.75 MM X 32 MM SYNERGY STENT SYSTEMS. FOLLOWING POST-DILATATION, THE RESIDUAL STENOSIS WAS 0%. THE TARGET LESION 2 WAS LOCATED IN THE MIDDLE RCA EXTENDING UP TO DISTAL RCA WITH 95% STENOSIS AND WAS 46 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.75 MM. THE TARGET LESION 2 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.50 MM X 38 MM OVERLAPPED ON TO 2.75 MM X 12 MM SYNERGY STENT SYSTEMS. FOLLOWING POST-DILATATION, THE RESIDUAL STENOSIS WAS 0%. THREE DAYS LATER, THE SUBJECT WAS DISCHARGED ON (B)(6) 2020 ON ASPIRIN AND TICAGRELOR. IN (B)(6) 2022, THE SUBJECT WAS DIAGNOSED WITH A CORONARY ATHEROSCLEROTIC HEART DISEASE AND WAS HOSPITALIZED ON SAME DAY FOR FURTHER TREATMENT. ANGIOGRAPHY WITHOUT REVASCULARIZATION WAS PERFORMED TO TREAT THE EVENT. THE EVENT WAS CONSIDERED TO BE RECOVERED/RESOLVED AND ON THE SAME DAY THE SUBJECT WAS DISCHARGED ON ASPIRIN AND TICAGRELOR.
SYNERGY CHINA REGISTRY. IT WAS REPORTED THAT CORONARY ATHEROSCLEROTIC HEART DISEASE OCCURRED. IN (B)(6) 2020, THE SUBJECT WAS REFERRED FOR CARDIAC CATHETERIZATION AND THE INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. THE TARGET LESION 1 WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) EXTENDING UP TO MIDDLE RCA WITH 99% STENOSIS AND WAS 54 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.5 MM. THE TARGET LESION 1 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.00 MM X 32 MM OVERLAPPED ON TO 3.50 MM X 28 MM SYNERGY STENT SYSTEMS. FOLLOWING POST-DILATATION, THE RESIDUAL STENOSIS WAS 0%. SEVEN DAYS LATER, IN (B)(6) 2020, A STAGED PROCEDURE WAS PERFORMED AND TARGET LESION 1 WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) EXTENDING UP TO MIDDLE LAD WITH 90% STENOSIS AND WAS 66 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.75 MM. THE TARGET LESION 1 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.50 MM X 38 MM OVERLAPPED ON TO 2.75 MM X 32 MM SYNERGY STENT SYSTEMS. FOLLOWING POST-DILATATION, THE RESIDUAL STENOSIS WAS 0%. THE TARGET LESION 2 WAS LOCATED IN THE MIDDLE RIGHT CORONARY ARTERY (RCA) EXTENDING UP TO DISTAL RCA WITH 95% STENOSIS AND WAS 46 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.75 MM. THE TARGET LESION 2 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.50 MM X 38 MM OVERLAPPED ON TO 2.75 MM X 12 MM SYNERGY STENT SYSTEMS. FOLLOWING POST-DILATATION, THE RESIDUAL STENOSIS WAS 0%. THREE DAYS LATER, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND TICAGRELOR. IN (B)(6) 2022, THE SUBJECT WAS DIAGNOSED WITH CORONARY ATHEROSCLEROTIC HEART DISEASE AND WAS HOSPITALIZED ON SAME DAY FOR FURTHER TREATMENT. ANGIOGRAPHY WITHOUT REVASCULARIZATION WAS PERFORMED AND MEDICATION WAS GIVEN TO TREAT THE EVENT. THREE DAYS LATER, THE EVENT WAS CONSIDERED TO BE RECOVERED/RESOLVED AND ON THE SAME DAY THE SUBJECT WAS DISCHARGED ON ASPIRIN AND TICAGRELOR. IT WAS FURTHER REPORTED THAT ANGIOGRAPHY WITHOUT REVASCULARIZATION WAS PERFORMED FOR EVENT CORONARY ATHEROSCLEROTIC HEART DISEASE WITH NO MEDICATION GIVEN TO TREAT THE EVENT AS PREVIOUSLY REPORTED. NO OTHER ACTION WAS TAKEN TO TREAT THE EVENT. IT WAS FURTHER REPORTED THAT TARGET LESION 2 WAS LOCATED IN THE PROXIMAL LEFT CIRCUMFLEX (LCX) ARTERY EXTENDING FIRST OBTUSE MARGINAL AND NOT MIDDLE RCA EXTENDING TO DISTAL RCA AS PREVIOUSLY REPORTED. IT WAS FURTHER REPORTED THAT IN (B)(6) 2022, THE SUBJECT WAS ON ASPIRIN AND TICAGRELOR AT THE TIME OF THE EVENT. IT WAS NOTED THAT CORONARY ANGIOGRAPHY REVEALED 70% STENOSIS IN THE PROXIMAL LAD STENT AND 70% STENOSIS IN THE PROXIMAL LCX STENT. THE EVENT WAS TREATED MEDICALLY.
SYNERGY CHINA REGISTRY IT WAS REPORTED THAT CORONARY ATHEROSCLEROTIC HEART DISEASE OCCURRED. IN (B)(6) 2020, THE SUBJECT INDEX PROCEDURE WAS PERFORMED. THE TARGET LESION 1 WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) EXTENDING UP TO MIDDLE RCA WITH 99% STENOSIS AND WAS 54 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.5 MM. THE TARGET LESION 1 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.00 MM X 32 MM OVERLAPPED ON TO 3.50 MM X 28 MM SYNERGY STENT SYSTEMS. FOLLOWING POST-DILATATION, THE RESIDUAL STENOSIS WAS 0%. IN (B)(6) 2020, STAGED PROCEDURE WAS PERFORMED AND THE TARGET LESION 1 WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) EXTENDING UP TO MIDDLE LAD WITH 90% STENOSIS AND WAS 66 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.75 MM. THE TARGET LESION 1 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.50 MM X 38 MM OVERLAPPED ON TO 2.75 MM X 32 MM SYNERGY STENT SYSTEMS. FOLLOWING POST-DILATATION, THE RESIDUAL STENOSIS WAS 0%. THE TARGET LESION 2 WAS LOCATED IN THE MIDDLE RCA EXTENDING UP TO DISTAL RCA WITH 95% STENOSIS AND WAS 46 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.75 MM. THE TARGET LESION 2 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.50 MM X 38 MM OVERLAPPED ON TO 2.75 MM X 12 MM SYNERGY STENT SYSTEMS. FOLLOWING POST-DILATATION, THE RESIDUAL STENOSIS WAS 0%. THREE DAYS LATER, THE SUBJECT WAS DISCHARGED ON (B)(6) 2020 ON ASPIRIN AND TICAGRELOR. IN (B)(6) 2022, THE SUBJECT WAS DIAGNOSED WITH A CORONARY ATHEROSCLEROTIC HEART DISEASE AND WAS HOSPITALIZED ON SAME DAY FOR FURTHER TREATMENT. ANGIOGRAPHY WITHOUT REVASCULARIZATION WAS PERFORMED TO TREAT THE EVENT. THE EVENT WAS CONSIDERED TO BE RECOVERED/RESOLVED AND ON THE SAME DAY THE SUBJECT WAS DISCHARGED ON ASPIRIN AND TICAGRELOR. IT WAS FURTHER REPORTED THAT TARGET LESION 2 WAS LOCATED IN THE PROXIMAL LEFT CIRCUMFLEX (LCX) ARTERY EXTENDING FIRST OBTUSE MARGINAL AND NOT MIDDLE RCA EXTENDING TO DISTAL RCA AS PREVIOUSLY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2251716 | SYNERGY | CORONARY DRUG-ELUTING STENT | NIQ | BOSTON SCIENTIFIC CORPORATION | 10623 | 0025011783 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Male | Other| R| H |