FDA Adverse Event
Death
Summary report: N
ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT MX2
MDR report key: 1263436
·
Received December 12, 2008
Report
- Report Number
- 2953200-2008-01161
- Event Type
- Death
- Date Received
- December 12, 2008
- Date of Event
- October 21, 2008
- Report Date
- November 13, 2008
- Manufacturer
- MEDTRONIC CARDIOVASCULAR GALWAY
- Product Code
- NIQ
- PMA / PMN Number
- P060033
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
TWO ENDEAVOR MX2 DRUG-ELUTING STENTS (3.0 X 12MM AND 2.5 X 24MM) (MFR REPORT# 2953200-2008-001160) WERE SUCCESSFULLY IMPLANTED, OVERLAPPING, IN THE LEFT MAIN. IT IS REPORTED THAT 12 DAYS LATER THE PT SUFFERED A SUDDEN DEATH. CIRCUMSTANCES AND CAUSE OF DEATH ARE UNK. INVESTIGATOR INDICATED THAT EVENT WAS NOT RELATED TO THE STUDY STENT. NO AUTOPSY REPORT IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT MX2 | NIQ | MEDTRONIC CARDIOVASCULAR GALWAY | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Death | HOURS BEFORE THE EVENT| PATIENT TAKING ASA AND CLOPIDOGREL/TICLOPIDINGE 24 |