FDA Adverse Event
Injury
Summary report: N
ENDEAVOR SPRINT RX
MDR report key: 3031888
·
Received April 3, 2013
Report
- Report Number
- 9612164-2013-00362
- Event Type
- Injury
- Date Received
- April 3, 2013
- Date of Event
- May 11, 2012
- Report Date
- March 19, 2013
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- NIQ
- PMA / PMN Number
- P060033
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PL
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
RESULTS: MYOCARDIAL INFARCTION. CONCLUSIONS: MYOCARDIAL INFARCTION. (B)(4).
Description of Event or Problem · 1
DURING THE INDEX PROCEDURE THE PATIENT HAD ONE ENDEAVOR SPRINT DRUG ELUTING STENT IMPLANTED IN THE RCA. IT IS REPORTED THAT APPROXIMATELY 46 MONTHS POST INDEX PROCEDURE THE PATIENT SUFFERED A MI. THE EVENT WAS NOT ASSESSED FOR RELATEDNESS TO DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 136107 | ENDEAVOR SPRINT RX | STENT, CORONARY, DRUG-ELUTING | NIQ | MEDTRONIC IRELAND | 0000493260 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00058 YR | ASPIRIN |