FDA Adverse Event
Death
Summary report: N
ENDEAVOR RX CORONARY STENT SYSTEM
MDR report key: 1696190
·
Received May 20, 2010
Report
- Report Number
- 2953200-2010-00885
- Event Type
- Death
- Date Received
- May 20, 2010
- Date of Event
- December 7, 2008
- Report Date
- April 21, 2010
- Manufacturer
- MEDTRONIC CARDIOVASCULAR GALWAY
- Product Code
- NIQ
- PMA / PMN Number
- P060033
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B) (4). EVALUATION RESULTS: DEATH.
Description of Event or Problem · 1
PT RECEIVED AN ENDEAVOR RX DRUG-ELUTING STENT DURING INDEX PROCEDURE. APPROXIMATELY 9 MONTHS POST STENT IMPLANT, PT DEATH WAS REPORTED TO HAVE OCCURRED. CAUSE OF DEATH IS REPORTED AS UNK.
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 | 82 YR | Death |