FDA Adverse Event
Malfunction
Summary report: N
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
MDR report key: 664349
·
Received January 10, 2006
Report
- Report Number
- 6000089-2005-01921
- Event Type
- Malfunction
- Date Received
- January 10, 2006
- Date of Event
- October 12, 2005
- Report Date
- October 13, 2005
- Manufacturer
- BOSTON SCIENTIFIC
- Product Code
- NIQ
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THIS EVENT IS NOW REPORTABLE BASED ON THE ANALYSIS COMPLETED ON 12/21/2005. IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, A SHAFT KINK OCCURRED. NO PATIENT INJURIES OR COMPLICATIONS WERE REPORTED. HOWEVER, THE RETURNED PRODUCT CONFIRMED THAT THERE WAS A SHAFT KINK AS WELL AS A FRACTURE OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM | DRUG COATED STENT | NIQ | BOSTON SCIENTIFIC | TAXUS EXPRESS2 8.8% 3.00 X 24 MM | 7264702 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |