FDA Adverse Event
Injury
Summary report: N
CYPHER SIROLIMUS-ELUTING CORONARY STENT
MDR report key: 1083544
·
Received July 28, 2008
Report
- Report Number
- 9616099-2008-01858
- Event Type
- Injury
- Date Received
- July 28, 2008
- Date of Event
- November 16, 2007
- Report Date
- July 1, 2008
- Manufacturer
- CORDIS DE MEXICO
- Product Code
- NIQ
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES PRODUCT. THE PRODUCT REMAINS IMPLANTED IN THE PT AND IS NOT AVAILABLE FOR ANALYSIS. ADD'L INFO WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.
Description of Event or Problem · 1
THE MALE PT WAS ENROLLED IN THE STUDY. THE TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD). THE LESION WAS AN IN-STENT RESTENOSIS OF A PREVIOUSLY IMPLANTED CYPHER 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 | 72 YR | Hospitalization| R | CLOPIDOGREL| ASPIRIN |