FDA Adverse Event
Injury
Summary report: N
CYPHER SIROLIMUS-ELUTING CORONARY STENT
MDR report key: 797461
·
Received December 19, 2006
Report
- Report Number
- 9616099-2006-01643
- Event Type
- Injury
- Date Received
- December 19, 2006
- Date of Event
- July 21, 2006
- Report Date
- November 10, 2006
- Manufacturer
- CORDIS DE MEXICO
- Product Code
- NIQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS FILE HAS BEEN RE-ACCESS AS PER THE SIMILAR DEVICE REPORTABILITY CRITERIA IMPLEMENTED BY CORDIS CORPORATION ON 12/15/06. THE MDR DETERMINATION HAS CHANGED FROM NOT REPORTABLE TO A REPORTABLE EVENT, AS THE DEVICE IS CONSIDERED TO BE SIMILAR TO THE UNITED STATES PRODUCT. PLEASE NOTE: DEVICE (CRA33275 LOT# UNK) IS DISTRIBUTED OUTSIDE THE UNITED STATES. HOWEVER, IT IS SIMILAR TO THE UNITED STATES PRODUCT CXS33275. ANY ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
Description of Event or Problem · 1
THE FOLLOWING REPORT WAS RECEIVED FROM THE CACTUS CLINICAL STUDY: APPROXIMATELY FIVE MONTHS POST INDEX PROCEDURE, THE PT WAS REVASCULARIZED FOR 80 RESTENOSIS OF THE TARGET LESION AT 1ST OBTUSE MARGINAL. THE PT WAS TREATED WITH AN UNK BRAND 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 | 59 YR | Hospitalization| L| R |