FDA Adverse Event
Injury
Summary report: N
ENDEAVOR SPRINT RX
MDR report key: 2781831
·
Received October 11, 2012
Report
- Report Number
- 9612164-2012-01504
- Event Type
- Injury
- Date Received
- October 11, 2012
- Date of Event
- May 23, 2012
- Report Date
- March 20, 2014
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- NIQ
- PMA / PMN Number
- P060033
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
RESULTS: INHERENT RISK OF PROCEDURE (MI).
Description of Event or Problem · 1
DURING INDEX PROCEDURE, THE PATIENT HAD ONE ENDEAVOR SPRINT DRUG-ELUTING STENT SUCCESSFULLY DEPLOYED AT LEFT MAIN. APPROXIMATELY 9 MONTHS POST INDEX PROCEDURE, PATIENT EXPERIENCED AN MI. INVESTIGATOR INDICATED THAT THE EVENT WAS UNLIKELY TO BE RELATED TO THE STUDY DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDEAVOR SPRINT RX | STENT, CORONARY, DRUG-ELUTING | NIQ | MEDTRONIC IRELAND | 0005198793 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00044 YR | Hospitalization | ASA AND CLOPIDOGREL |