FDA Adverse Event
Death
Summary report: N
CYPHER SIROLIMUS-ELUTING CORONARY STENT
MDR report key: 1111652
·
Received August 11, 2008
Report
- Report Number
- 9616099-2008-01956
- Event Type
- Death
- Date Received
- August 11, 2008
- Date of Event
- March 2, 2008
- Report Date
- July 15, 2008
- Manufacturer
- CORDIS DE MEXICO
- Product Code
- NIQ
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE UNITED STATES PRODUCT. THE PRODUCT REMAINS IMPLANTED IN THE PATIENT AND WAS NOT AVAILABLE FOR ANALYSIS. DEVICE HISTORY RECORD REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.
Description of Event or Problem · 1
IN 2008, THE MALE PATIENT HAD ONE CYPHER SELECT STENT IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING. THREE DAYS AFTER THE PCI, THE PATIENT EXPERIENCED CARDIOGENIC SHOCK AND DIED SUDDENLY.
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 | 13304401 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Death | CLOPIDOGREL| ASPIRIN |