FDA Adverse Event
Injury
Summary report: N
ENDEAVOR SPRINT RX
MDR report key: 3010171
·
Received March 19, 2013
Report
- Report Number
- 9612164-2013-00310
- Event Type
- Injury
- Date Received
- March 19, 2013
- Date of Event
- July 5, 2011
- Report Date
- February 19, 2013
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- NIQ
- PMA / PMN Number
- P060033
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EVALUATION: INHERENT RISK OF PROCEDURE - (MYOCARDIAL INFARCTION). (B)(4).
Description of Event or Problem · 1
DURING INDEX PROCEDURE THE PATIENT HAD TWO ENDEAVOR SPRINT DRUG ELUTING STENTS IMPLANTED IN THE LAD. FIVE DAYS POST INDEX PROCEDURE DURING A STAGED PROCEDURE THE PATIENT HAD FIVE ENDEAVOR SPRINT DRUG ELUTING STENTS IMPLANTED IN THE RCA. IT IS REPORTED THAT ON THE DAY OF THE STAGED PROCEDURE THE PATIENT SUFFERED AN MI. THE EVENT WAS NOT ASSESSED FOR RELATEDNESS TO DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 113257 | ENDEAVOR SPRINT RX | STENT, CORONARY, DRUG-ELUTING | NIQ | MEDTRONIC IRELAND |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization | ASPIRIN AND CLOPIDOGREL |