FDA Adverse Event
Injury
Summary report: N
CYPHER SIROLIMUS-ELUTING CORONARY STENT
MDR report key: 1190289
·
Received October 6, 2008
Report
- Report Number
- 3003742446-2008-00189
- Event Type
- Injury
- Date Received
- October 6, 2008
- Date of Event
- August 23, 2005
- Report Date
- September 18, 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
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE STENT WAS NOT RETURNED FOR EVALUATION; IT REMAINED IMPLANTED. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE DONE WITHOUT A LOT NUMBER. STENT THROMBOSIS IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH CORONARY ARTERY STENTING. WITH SUCH LIMITED INFORMATION, IT IS NOT POSSIBLE TO DETERMINE WHAT FACTORS MAY HAVE CONTRIBUTED TO THIS EVENT.
Description of Event or Problem · 1
THIS PATIENT EXPERIENCED STENT THROMBOSIS LEADING TO MYOCARDIAL INFARCTION FOLLOWING CYPHER STENT IMPLANTATION IN THE RCA. AS REPORTED, CORONARY ARTERY BYPASS SURGERY IS "GUARANTEED IN THE FUTURE". NO OTHER INFORMATION HAS BEEN PROVIDED.
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 | 51 YR | Hospitalization| L| R |