FDA Adverse Event
Injury
Summary report: N
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
MDR report key: 2041160
·
Received March 29, 2011
Report
- Report Number
- 9612164-2011-00120
- Event Type
- Injury
- Date Received
- March 29, 2011
- Date of Event
- February 17, 2011
- Report Date
- March 4, 2011
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- NIQ
- PMA / PMN Number
- P060033
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). RESULTS: DISSECTION. CONCLUSIONS: NO CONCLUSION CAN BE DRAWN. BASED ON THE INFORMATION PROVIDED NO ROOT CAUSE CAN BE DETERMINED.
Description of Event or Problem · 1
ONE ENDEAVOR SPRINT RX DRUG ELUTING STENT WAS IMPLANTED TO THE PROXIMAL LAD. A DISSECTION WAS REPORTED TO HAVE OCCURRED AND ANOTHER ENDEAVOR SPRINT RX DRUG ELUTING STENT WAS IMPLANTED TO TREAT IT. PATIENT WAS DISCHARGED ONE DAY POST INDEX PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDEAVOR SPRINT RX CORONARY STENT SYSTEM | NIQ | MEDTRONIC IRELAND | NA | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Required Intervention |