FDA Adverse Event
Injury
Summary report: N
CYPHER SIROLIMUS-ELUTING CORONARY STENT
MDR report key: 1083533
·
Received July 23, 2008
Report
- Report Number
- 9616099-2008-01827
- Event Type
- Injury
- Date Received
- July 23, 2008
- Date of Event
- June 18, 2007
- Report Date
- July 18, 2008
- Manufacturer
- CORDIS DE MEXICO
- Product Code
- NIQ
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS IS ONE OF TWO PRODUCTS BEING REPORTED FOR THE SAME EVENT. PLEASE REFERENCE MFR REPORTS #: 9616099-2008-01827 AND 9616099-2008-01829. ANY ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
Description of Event or Problem · 1
NOTIFICATION WAS RECEIVED FROM THE REGISTRY INDICATING THAT THIS PT WAS ENROLLED THE STUDY IN 2007 WITH 1-VESSEL DISEASE. THE TARGET LESION WAS A 90% RESTENOTIC LESION PREVIOUSLY TREATED WITH TWO CYPHER SELECT STENT IN (2006). THE MAIN INDICATION FOR THE INTERVENTION WAS UNSTABLE ANGINA PECTORIS. THE RESTENOSIS WAS TREATED DURING THE STUDY'S INDEX PROCEDURE USING A 3.0X13MM CYPHER SELECT STENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CYPHER SIROLIMUS-ELUTING CORONARY STENT | DRUG-ELUTING STENT (NIQ) | NIQ | CORDIS DE MEXICO | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Hospitalization| R |