FDA Adverse Event
Injury
Summary report: N
ENDEAVOR SPRINT RX
MDR report key: 3001984
·
Received March 13, 2013
Report
- Report Number
- 9612164-2013-00280
- Event Type
- Injury
- Date Received
- March 13, 2013
- Date of Event
- January 6, 2013
- Report Date
- April 2, 2014
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- NIQ
- PMA / PMN Number
- P060033
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- 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 ENDEAVOR SPRINT DRUG ELUTING STENT WAS IMPLANTED IN THE LAD.
Description of Event or Problem · 1
PATIENT RECEIVED AN ENDEAVOR SPRINT RX DURING INDEX PROCEDURE. HOWEVER IT WAS REPORTED THAT THE PATIENT SUFFERED AN MI SOME TIME POST PROCEDURE. IT IS UNKNOWN IF IT WAS RELATED TO THE TARGET VESSEL. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS POSSIBLY RELATED TO THE STUDY DEVICE. THE PATIENT RECOVERED. NO OTHER CLINICAL SEQUELAE WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 105165 | ENDEAVOR SPRINT RX | STENT, CORONARY, DRUG-ELUTING | NIQ | MEDTRONIC IRELAND |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00069 YR | Hospitalization | PLAVIX AND ASPIRIN |