FDA Adverse Event
Malfunction
Summary report: N
TAXUS LIBERTE' PACLITAXEL-ELUTING CORONARY STENT SYSTEM
MDR report key: 1234058
·
Received November 4, 2008
Report
- Report Number
- 2134265-2008-04210
- Event Type
- Malfunction
- Date Received
- November 4, 2008
- Date of Event
- September 28, 2008
- Report Date
- October 13, 2008
- Manufacturer
- BOSTON SCIENTIFIC
- Product Code
- NIQ
- PMA / PMN Number
- P060008
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EG
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING PREPARATION FOR A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, A FRACTURED SHAFT WAS FOUND. WHEN THE PHYSICIAN WAS OPENING THE TAXUS LIBERTE' 2.75X38MM DRUG ELUTING STENT, IT WAS NOTED THAT THE SHAFT WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER TAXUS LIBERTE' STENT. AS THERE WAS NO PT INVOLVEMENT, NO COMPLICATIONS OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TAXUS LIBERTE' PACLITAXEL-ELUTING CORONARY STENT SYSTEM | NIQ STENT, CORONARY, DRUG-ELUTING | NIQ | BOSTON SCIENTIFIC | 2.75X38MM | 11836602 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR |