FDA Adverse Event
Death
Summary report: N
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
MDR report key: 788193
·
Received November 28, 2006
Report
- Report Number
- 6000093-2006-02450
- Event Type
- Death
- Date Received
- November 28, 2006
- Date of Event
- March 2, 2005
- Report Date
- October 30, 2006
- Manufacturer
- BOSTON SCIENTIFIC
- Product Code
- NIQ
- PMA / PMN Number
- p030025
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
H6. THE DELIVERY DEVICE WAS DISPOSED AND THE STENT REMAINED IN THE PT. THEREFORE, NO ANALYSIS COULD BE PERFORMED. THE MFG RECORDS FOR TOP ASSEMBLY BATCH 7142543 HAVE BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND. THIS RECORDS REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS.
Description of Event or Problem · 1
IT WAS REPORTED THAT POST A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, A DEATH OCCURRED. "SON OF CONSUMER STATES THAT HIS FATHER DIED IN 2005. SON DOES NOT KNOW THE OFFICIAL CAUSE OF DEATH." ADDITIONAL INFO REGARDING THIS EVENT IS NOT 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 | 2.5X16MM | 7142543 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Death |