FDA Adverse Event
Injury
Summary report: N
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
MDR report key: 1181127
·
Received September 30, 2008
Report
- Report Number
- 2134265-2008-02845
- Event Type
- Injury
- Date Received
- September 30, 2008
- Report Date
- September 2, 2008
- Manufacturer
- BOSTON SCIENTIFIC
- Product Code
- NIQ
- PMA / PMN Number
- P030025
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- ATTORNEY
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WILL NOT BE RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.
Description of Event or Problem · 1
IT WAS REPORTED THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, A THROMBOSIS OCCURRED. A TAXUS EXPRESS2 2.5X16MM DRUG ELUTING STENT WAS PLACED. POST PROCEDURE, THE PT PRESENTED WITH AN MI AND IN STENT THROMBOSIS. ADDITIONAL INFO HAS BEEN REQUESTED.
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 | 2.5X12MM |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Other |