FDA Adverse Event
Injury
Summary report: N
ENDEAVOR SPRINT RX
MDR report key: 3023271
·
Received March 27, 2013
Report
- Report Number
- 9612164-2013-00338
- Event Type
- Injury
- Date Received
- March 27, 2013
- Date of Event
- July 4, 2012
- Report Date
- March 12, 2013
- 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
EVALUATION RESULTS: INHERENT RISK OF PROCEDURE - (MYOCARDIAL INFARCTION). EVALUATION CONCLUSIONS: INHERENT RISK OF PROCEDURE - (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 RAMUS. APPROXIMATELY 9 MONTHS POST INDEX PROCEDURE, THE PATIENT UNDERWENT A BALLOON ONLY REVASCULARIZATION OF THE TARGET VESSEL WITH POBA. ONE DAY LATER, THE PATIENT SUFFERED AN MI WHICH WAS RELATED TO THE TV. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS DEFINITELY RELATED TO THE STUDY DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 125590 | ENDEAVOR SPRINT RX | STENT, CORONARY, DRUG-ELUTING | NIQ | MEDTRONIC IRELAND | 0005601242 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00074 YR | Required Intervention | CLOPIDOGREL AND ASPIRIN. |