FDA Adverse Event
Other
Summary report: N
CYPHER
MDR report key: 502011
·
Received December 3, 2003
Report
- Report Number
- 502011
- Event Type
- Other
- Date Received
- December 3, 2003
- Date of Event
- October 1, 2003
- Report Date
- November 1, 2003
- Manufacturer
- CORDIS CORP
- Product Code
- NIQ
- Report Source
- User Facility report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
A CYPHER STENT WAS PLACED IN THE PDA [POSTERIOR DESCENDING ARTERY] IN 2003. THE PT WAS BROUGHT BACK TO INTERVENE ON THE MID RCA [RIGHT CORONARY ARTERY]. WHEN THE PICTURES WERE TAKEN, THE CYPHER STENT WAS NOTED TO BE OCCLUDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CYPHER | STENT | NIQ | CORDIS CORP | H739CXS182502 | A0903580 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Other |