SYNERGY XD
Report
- Report Number
- 2124215-2025-63039
- Event Type
- Injury
- Date Received
- September 12, 2025
- Date of Event
- September 4, 2025
- Report Date
- October 28, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- NIQ
- UDI-DI
- 08714729980278
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
E1 INITIAL REPORTER ADDRESS: (B)(6).
E1 INITIAL REPORTER ADDRESS: (B)(6).
IT WAS REPORTED THAT A DISSECTION OCCURRED. THE PATIENT PRESENTED WITH AN INFERIOR WALL MYOCARDIAL INFARCTION. THE TARGET LESION WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY. A 2.75 X 28MM SYNERGY XD DRUG-ELUTING STENT (DES) WAS DEPLOYED. POST DEPLOYMENT, A TYPE B FLOW-LIMITING DISTAL STENT EDGE DISSECTION WAS OBSERVED, WITH TIMI II FLOW NOTED. THE DISSECTION WAS COVERED WITH 2.50 X 12MM SYNERGY XD DES, AND THE PROCEDURE WAS COMPLETED. THE PATIENT WAS STABLE POST PROCEDURE AND FULLY RECOVERED.
IT WAS REPORTED THAT A DISSECTION OCCURRED. THE PATIENT PRESENTED WITH AN INFERIOR WALL MYOCARDIAL INFARCTION. THE TARGET LESION WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY. A 2.75 X 28MM SYNERGY XD DRUG-ELUTING STENT (DES) WAS DEPLOYED. POST DEPLOYMENT, A TYPE B FLOW-LIMITING DISTAL STENT EDGE DISSECTION WAS OBSERVED, WITH TIMI II FLOW NOTED. THE DISSECTION WAS COVERED WITH 2.50 X 12MM SYNERGY XD DES, AND THE PROCEDURE WAS COMPLETED. THE PATIENT WAS STABLE POST PROCEDURE AND FULLY RECOVERED. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS 90% STENOSED, MODERATELY TORTUOUS AND MODERATELY CALCIFIED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2304830 | SYNERGY XD | CORONARY DRUG-ELUTING STENT | NIQ | BOSTON SCIENTIFIC CORPORATION | 0035525324 | 08714729980278 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Male | Required Intervention |