FDA Adverse Event
Death
Summary report: N
CYPHER SIROLIMUS-ELUTING CORONARY STENT
MDR report key: 548644
·
Received October 13, 2004
Report
- Report Number
- 9616099-2004-00477
- Event Type
- Death
- Date Received
- October 13, 2004
- Date of Event
- September 25, 2004
- Report Date
- October 13, 2004
- Manufacturer
- CORDIS DE MEXICO
- Product Code
- NIQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
SAT AND DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CYPHER SIROLIMUS-ELUTING CORONARY STENT | DRUG-ELUTING STENT | NIQ | CORDIS DE MEXICO | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Death | ANOTHER 3.5X18MM IN THE PROXIMAL LAD. |