FDA Adverse Event
Death
Summary report: N
ENDEAVOR RX CORONARY STENT SYSTEM
MDR report key: 1162667
·
Received September 16, 2008
Report
- Report Number
- 2953200-2008-00812
- Event Type
- Death
- Date Received
- September 16, 2008
- Date of Event
- June 13, 2008
- Report Date
- August 18, 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
- CH
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE LESION WAS LOCATED IN THE DISTAL LAD AND WAS SUCCESSFULLY TREATED WITH ONE ENDEAVOR DRUG-ELUTING STENT. DIAMETER RESIDUAL STENOSIS OF LESION 10%. AT 30 DAYS PT HAD UNSTABLE ANGINA. PT EXPIRED APPROXIMATELY 45 DAYS POST STENT IMPLANT. INVESTIGATOR INDICATED THAT PT DEATH WAS NOT ASSESSABLE IN RELATION TO THE ENDEAVOR DRUG-ELUTING STENT. PLEASE NOTE THAT THIS DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDEAVOR RX CORONARY STENT SYSTEM | NIQ | MEDTRONIC CARDIOVASCULAR GALWAY | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Death |