FDA Adverse Event
Injury
Summary report: N
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
MDR report key: 1081433
·
Received July 25, 2008
Report
- Report Number
- 2134265-2008-02104
- Event Type
- Injury
- Date Received
- July 25, 2008
- Report Date
- June 26, 2008
- Manufacturer
- BOSTON SCIENTIFIC
- Product Code
- NIQ
- PMA / PMN Number
- P030025
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AS NO DEVICE WAS RECEIVED FOR ANALYSIS, IT IS NOT POSSIBLE TO PERFORM ANY INSPECTIONS ON THE DEVICE. THEREFORE, IT IS NOT POSSIBLE TO DETERMINE IF ANY ISSUES EXISTED WITH THE ACTUAL UNIT THAT COULD HAVE CONTRIBUTED TO THE COMPLAINT. AS THE BATCH NUMBER IS UNKNOWN, A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CARRIED OUT. THE ROOT CAUSE WILL BE DOCUMENTED AS ANTICIPATED PROCEDURAL COMPLICATION, DUE TO A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE NOTED WITHIN THE DIRECTIONS FOR USE, AND/OR DEVICE LABELING.
Description of Event or Problem · 1
IT WAS REPORTED BY THE PATIENT, THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, LATE STENT THROMBOSIS OCCURRED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM | NIQ STENT, CORONARY, DRUG-ELUTING | NIQ | BOSTON SCIENTIFIC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |