FDA Adverse Event
Injury
Summary report: N
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
MDR report key: 2181157
·
Received July 21, 2011
Report
- Report Number
- 9612164-2011-00820
- Event Type
- Injury
- Date Received
- July 21, 2011
- Date of Event
- July 3, 2011
- Report Date
- July 5, 2011
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- NIQ
- PMA / PMN Number
- P060033
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVAL, RESULTS: (STENT THROMBOSIS, MI).
Description of Event or Problem · 1
PT HAD A 3.0 MM DIAMETER X 15 MM LENGTH ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING STENT IMPLANTED IN THE PROXIMAL LAD DURING A REVASCULARIZATION PROCEDURE. APPROXIMATELY 3 WEEKS LATER, THE PT SUFFERED A CORONARY STENT THROMBOSIS. IT WAS REPORTED THAT THE PT WAS "FOUND TO BE INVOLVED IN STEMI". PT CHANGED FROM PLAVIX TO EFFIENT. THE PT UNDERWENT THROMBOLYTIC THERAPY AND PERCUTANEOUS INTERVENTION. PT RECOVERED WITH TREATMENT AND NO OTHER CLINICAL SEQUELAE WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDEAVOR SPRINT RX CORONARY STENT SYSTEM | NIQ | MEDTRONIC IRELAND | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Required Intervention | ASPIRIN| CLOPIDOGREL |