FDA Adverse Event Death Summary report: N

CYPHER SIROLIMUS-ELUTING CORONARY STENT

MDR report key: 548644 · Received October 13, 2004

Report

Report Number
9616099-2004-00477
Event Type
Death
Date Received
October 13, 2004
Date of Event
September 25, 2004
Report Date
October 13, 2004
Manufacturer
CORDIS DE MEXICO
Product Code
NIQ
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
JA
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

SAT AND DEATH.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT NIQ CORDIS DE MEXICO NA UNK

Patients

Seq Age Sex Outcome Treatment
1 UNKNOWN Death ANOTHER 3.5X18MM IN THE PROXIMAL LAD.