FDA Adverse Event
Injury
Summary report: N
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
MDR report key: 2100443
·
Received May 17, 2011
Report
- Report Number
- 9612164-2011-00427
- Event Type
- Injury
- Date Received
- May 17, 2011
- Date of Event
- January 1, 2011
- Report Date
- April 19, 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). EVAL, RESULTS, CONCLUSION: ROOT CAUSE OF THE EVENT CANNOT BE CONFIRMED BASED ON LIMITED INFO AVAILABLE. STENT THROMBOSIS.
Description of Event or Problem · 1
PT RECEIVED ONE ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG ELUTING CORONARY STENT DURING A PROCEDURE WITH NO ISSUE REPORTED. HOWEVER,IT WAS REPORTED THAT STENT THROMBOSIS WAS CONFIRMED WITHIN 24 HOURS FROM STENT IMPLANT. THE PT WAS REPORTED TO BE TAKING PLAVIX AT THE TIME OF THE EVENT. 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 | UNK | Hospitalization | PLAVIX |