FDA Adverse Event
Death
Summary report: N
ENDEAVOR CORONARY DRUG-ELUTING STENT
MDR report key: 1712887
·
Received June 4, 2010
Report
- Report Number
- 2953200-2010-01070
- Event Type
- Death
- Date Received
- June 4, 2010
- Date of Event
- August 18, 2007
- Report Date
- June 26, 2008
- Manufacturer
- MEDTRONIC CARDIOVASCULAR
- Product Code
- NIQ
- PMA / PMN Number
- P060033
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B) (4). RESULTS: DEATH.
Description of Event or Problem · 1
A 3.0 MM DIAMETER X 24 MM LENGTH ENDEAVOR DRUG-ELUTING CORONARY STENT WAS SUCCESSFULLY IMPLANTED IN THE PROXIMAL TO MID LAD. IT WAS REPORTED THAT 38 MONTHS POST INDEX PROCEDURE THAT THE PT EXPIRED OF UNK CAUSE. NO ADDITIONAL DETAILS HAVE BEEN PROVIDED. INVESTIGATOR ASSESSMENT STATED THAT THE RELATION BETWEEN THE STUDY DEVICE, DRUG AND THE EVENT IS NOT ASSESSABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDEAVOR CORONARY DRUG-ELUTING STENT | NIQ | MEDTRONIC CARDIOVASCULAR | NA | 57394 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Death |