FDA Adverse Event
Death
Summary report: N
CYPHER SIROLIMUS-ELUTING CORONARY STENT
MDR report key: 1002355
·
Received February 22, 2008
Report
- Report Number
- 3003742446-2008-00025
- Event Type
- Death
- Date Received
- February 22, 2008
- Date of Event
- October 24, 2004
- Report Date
- January 24, 2008
- Manufacturer
- CORDIS LLC (PR)
- Product Code
- NIQ
- PMA / PMN Number
- P020026
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.
Description of Event or Problem · 1
THE REPORT RECEIVED THROUGH THE LEGAL DEPARTMENT INDICATED THAT APPROXIMATELY ONE-YEAR AND TWO WEEKS AFTER THE INDEX PROCEDURE, THE PATIENT EXPIRED. THE PATIENT HAD A CYPHER STENT IMPLANTED IN THE RIGHT CORONARY ARTERY TARGET LESION DURING THE INDEX PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME. BASED ON ARC GUIDELINES, THE ADVERSE EVENT IS BEING CAPTURED/REPORTED AS A POSSIBLE VERY LATE STENT THROMBOSIS/THROMBOTIC EVENT.
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 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Death |