VERIFLEX LIBERTE' CORONARY STENT DELIVERY SYSTEM
Report
- Report Number
- 2134265-2009-06341
- Event Type
- Injury
- Date Received
- July 25, 2010
- Date of Event
- August 5, 2006
- Report Date
- August 5, 2006
- Manufacturer
- BOSTON SCIENTIFIC IRELAND LTD.
- Product Code
- MAF
- PMA / PMN Number
- P040016
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HU
- Reporter Occupation
- PHYSICIAN
Narratives
THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE BATCH NUMBER IS UNKNOWN THEREFORE, A REVIEW OF THE MANUFACTURING DOCUMENTATION COULD NOT BE PERFORMED. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION OF ANTICIPATED PROCEDURAL COMPLICATIONS. THIS COMPLAINT IS DUE TO A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE NOTED WITHIN THE DIRECTIONS FOR USE. (B)(4) : DEVICE NOT RETURNED FOR ANALYSIS.
(B)(4). IT WAS REPORTED THAT DURING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, THROMBUS OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING. THE TARGET VESSEL REFERENCE DIAMETER WAS 3.2MM AND THE LESION LENGTH WAS 16MM. PRE-PROCEDURE STENOSIS WAS 74%. POST-PROCEDURE WAS 6% STENOSIS. A 3.5X20MM LIBERTE STENT WAS IMPLANTED. A NON BSC BALLOON CATHETER WAS ALSO USED. DIRECT STENTING WAS NOT ATTEMPTED. THROMBUS ASPIRATION WAS COMPLETED TO REMOVE THROMBUS. THE PROCEDURE WAS A TECHNICAL SUCCESS. THE PATIENT WAS DISCHARGED THREE DAYS LATER WITHOUT CURRENT ANGINAL COMPLAINTS OR SILENT ISCHEMIA. DISCHARGE MEDICATION INCLUDES: ASA 100MG AND CLOPIDOGREL 75MG DAILY FOR 12 MONTHS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VERIFLEX LIBERTE' CORONARY STENT DELIVERY SYSTEM | STENT, CORONARY | MAF | BOSTON SCIENTIFIC IRELAND LTD. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Required Intervention | SPRINTER BALLOON CATHETER |