FDA Adverse Event
Malfunction
Summary report: N
CYPHER SIROLIMUS-ELUTING CORONARY STENT
MDR report key: 1041274
·
Received May 9, 2008
Report
- Report Number
- 9616099-2008-01255
- Event Type
- Malfunction
- Date Received
- May 9, 2008
- Date of Event
- April 9, 2008
- Report Date
- April 14, 2008
- Manufacturer
- CORDIS DE MEXICO
- Product Code
- NIQ
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS OUS CYPHER SELECT PLUS SIROLIMUS-ELUTING CORONARY STENT IS DISTRIBUTED OUTSIDE OF THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE UNITED STATES CYPHER SIROLIMUS-ELUTING CORONARY STENT. ADDITIONAL INFO WILL BE SUBMITTED UPON 30 DAYS OF RECEIPT.
Description of Event or Problem · 1
THE PT WAS ADMITTED FOR A PROCEDURE IN 2008 WITH A LESION IN THE RIGHT CORONARY ARTERY (RCA). A 3.0 X 28MM CYPHER SELECT PLUS STENT WAS UNABLE TO BE DEPLOYED AT THE TARGET LESION.
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 | 13360805 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |