FDA Adverse Event
Injury
Summary report: N
CYPHER SIROLIMUS-ELUTING CORONARY STENT
MDR report key: 474431
·
Received July 30, 2003
Report
- Report Number
- 3003742446-2003-00263
- Event Type
- Injury
- Date Received
- July 30, 2003
- Report Date
- July 30, 2003
- Manufacturer
- CORDIS LLR (PR)
- Product Code
- NIQ
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THROMBOSIS POST CORONARY STENT IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CYPHER SIROLIMUS-ELUTING CORONARY STENT | DRUG ELUTING STENT | NIQ | CORDIS LLR (PR) | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |