FDA Adverse Event
Death
Summary report: N
CYPHER SIROLIMUS-ELUTING CORONARY STENT
MDR report key: 507001
·
Received January 16, 2004
Report
- Report Number
- 3003742446-2004-00055
- Event Type
- Death
- Date Received
- January 16, 2004
- Report Date
- January 14, 2004
- Manufacturer
- CORDIS LLC (PR)
- Product Code
- NIQ
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
SAT POST STENT IMPLANTATION.
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 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Death| R |