FDA Adverse Event
Death
Summary report: N
ENDEAVOR SPRINT RX
MDR report key: 3804264
·
Received May 12, 2014
Report
- Report Number
- 9612164-2014-00506
- Event Type
- Death
- Date Received
- May 12, 2014
- Date of Event
- August 25, 2013
- Report Date
- July 9, 2014
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- NIQ
- PMA / PMN Number
- P060033
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
RESULTS, CONCLUSIONS: DEATH. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
DURING INDEX PROCEDURE, THE PATIENT HAD ONE ENDEAVOR SPRINT DRUG-ELUTING STENT IMPLANTED IN THE 1ST OM, ON THE SAME DAY THE PATIENT HAD 5 NON-MDT STENTS IMPLANTED IN THE RCA, 3RD RPL AND LCX. APPROXIMATELY 29 MONTHS POST INDEX PROCEDURE, THE PATIENT EXPIRED DUE TO ACUTE HEART FAILURE. INVESTIGATOR INDICATED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 283604 | ENDEAVOR SPRINT RX | STENT, CORONARY, DRUG-ELUTING | NIQ | MEDTRONIC IRELAND |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00073 YR | Death |