FDA Adverse Event
Injury
Summary report: N
CYPHER SIROLIMUS-ELUTING CORONARY STENT
MDR report key: 2243319
·
Received September 12, 2011
Report
- Report Number
- 3003742446-2011-00413
- Event Type
- Injury
- Date Received
- September 12, 2011
- Date of Event
- July 25, 2011
- Report Date
- August 23, 2011
- Manufacturer
- CORDIS LLC (PR)
- Product Code
- NIQ
- PMA / PMN Number
- P020026
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT REMAINS IMPLANTED IN THE PATIENT AND IS NOT AVAILABLE FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.
Description of Event or Problem · 1
THE (B)(6) MALE PATIENT WAS PART OF THE (B)(4) STUDY. THE PATIENT RECEIVED A 3.0 X 18MM CYPHER STENT IN THE DISTAL RCA. A YEAR AND A HALF AFTER THE INDEX PROCEDURE, THE PATIENT HAD A REVASCULARIZATION PERFORMED IN THE DISTAL TO PROXIMAL RCA. THE PATIENT RECEIVED TWO ENDEAVOR STENTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CYPHER SIROLIMUS-ELUTING CORONARY STENT | DRUG-ELUTING STENT (NIQ) | NIQ | CORDIS LLC (PR) | NA | 15077476 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Hospitalization| R |