PROMUS ELITE
Report
- Report Number
- 2124215-2024-49928
- Event Type
- Injury
- Date Received
- August 22, 2024
- Date of Event
- July 19, 2024
- Report Date
- September 19, 2024
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- NIQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
E1: INITIAL REPORTER ADDRESS 1: (B)(6).
E1: INITIAL REPORTER ADDRESS 1: (B)(6).
IT WAS REPORTED THAT A DISSECTION OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 3.00 X 24 MM PROMUS ELITE WAS DEPLOYED AND POST DILATED AND A PROXIMAL EDGE FLOW-LIMITING DISSECTION WAS NOTED. THE DISSECTION WAS COVERED WITH A 3.50 X 13 MM NON-BOSTON SCIENTIFIC (BSC) STENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS STABLE AFTER THE PROCEDURE AND FULLY RECOVERED. IT WAS FURTHER REPORTED THAT THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED RIGHT CORONARY ARTERY. A 2.5 X 15 MM SEMI-COMPLIANT BALLOON WAS UTILIZED TO PRE-DILATE THE LESION, FOLLOWED BY FULL DEPLOYMENT OF THE STENT UPON BALLOON INFLATION. THIS WAS SUCCEEDED BY POST-DILATION USING A 3.5 X 12 MM NON-COMPLIANT BALLOON.
IT WAS REPORTED THAT A DISSECTION OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY. A 3.00 X 24 MM PROMUS ELITE WAS DEPLOYED AND POST DILATED AND A PROXIMAL EDGE, FLOW-LIMITING DISSECTION WAS NOTED. THE DISSECTION WAS COVERED WITH A 3.50 X 13 MM NON-BOSTON SCIENTIFIC (BSC) STENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS STABLE AFTER THE PROCEDURE AND FULLY RECOVERED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2272426 | PROMUS ELITE | STENT, CORONARY, DRUG-ELUTING | NIQ | BOSTON SCIENTIFIC CORPORATION | 10674 | 0031490937 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |