FDA Adverse Event
Injury
Summary report: N
ENDEAVOR SPRINT TX CORONARY STENT SYSTEM
MDR report key: 2103661
·
Received May 19, 2011
Report
- Report Number
- 9612164-2011-00454
- Event Type
- Injury
- Date Received
- May 19, 2011
- Date of Event
- April 2, 2011
- Report Date
- April 22, 2011
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- NIQ
- PMA / PMN Number
- P060033
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
AN ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG ELUTING STENT WAS IMPLANTED IN THE MID LAD DURING INDEX PROCEDURE. IT IS REPORTED THAT THE PATIENT SUFFERED AN ACUTE STEMI APPROXIMATELY 4.5 MONTHS POST INDEX PROCEDURE. INVESTIGATOR HAS INDICATED THAT THE EVENT WAS RELATED TO THE STUDY DEVICE. IT IS REPORTED THAT THERE WAS REVASCULARIZATION CARRIED OUT TWO DAYS LATER AND THERE WAS TWO OTHER BRAND STENTS IMPLANTED IN THE MID LAD. IT IS REPORTED THAT THE PATIENT RECOVERED WITH TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDEAVOR SPRINT TX CORONARY STENT SYSTEM | NIQ | MEDTRONIC IRELAND | NA | 0003242656 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Required Intervention |