FDA Adverse Event
Death
Summary report: N
CYPHER SIROLIMUS-ELUTING CORONARY STENT
MDR report key: 500988
·
Received December 15, 2003
Report
- Report Number
- 3003742446-2003-00730
- Event Type
- Death
- Date Received
- December 15, 2003
- Date of Event
- November 13, 2003
- Report Date
- December 11, 2003
- Manufacturer
- CORDIS LLC (PR)
- Product Code
- NIQ
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
SAT POST 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 | 69 YR | Death| H| R |