FDA Adverse Event
Death
Summary report: N
CYPHER SIROLIMUS-ELUTING CORONARY STENT
MDR report key: 564050
·
Received January 5, 2005
Report
- Report Number
- 3003742446-2005-01194
- Event Type
- Death
- Date Received
- January 5, 2005
- Date of Event
- December 1, 2004
- Report Date
- January 5, 2005
- Manufacturer
- CORDIS LLC (PR)
- Product Code
- NIQ
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DC, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
SAT/DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CYPHER SIROLIMUS-ELUTING CORONARY STENT | DRUG-ELUTING STENT | NIQ | CORDIS LLC (PR) | NA | X0904800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Death | TAXUS STENT |