FDA Adverse Event
Injury
Summary report: N
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
MDR report key: 2141059
·
Received June 21, 2011
Report
- Report Number
- 9612164-2011-00607
- Event Type
- Injury
- Date Received
- June 21, 2011
- Date of Event
- February 11, 2008
- Report Date
- May 26, 2011
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- NIQ
- PMA / PMN Number
- P060033
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4): EVALUATION, RESULTS: MI. EVALUATION, CONCLUSION: NO CONCLUSION CAN BE DRAWN (BASED ON THE INFORMATION PROVIDED NO ROOT CAUSE CAN BE DETERMINED).
Description of Event or Problem · 1
DURING THE INDEX PROCEDURE, ONE ENDEAVOR SPRINT RX DRUG ELUTING STENT WAS IMPLANTED IN THE PROXIMAL LAD, AND 2 ENDEAVOR RX DRUG ELUTING STENTS WERE IMPLANTED IN THE 1ST DIAGONAL AND THE 1ST RPL. IT WAS REPORTED THROUGH THE CLINICAL EVENTS COMMITTEE THAT A SUSPECTED NON Q WAVE MI OCCURRED ONE DAY POST INDEX PROCEDURE IN THE TERRITORY OF THE TARGET VESSEL. PT WAS ASYMPTOMATIC AT 30 DAY, 6 MONTHS, 1 YEAR, 1.5 YEAR AND 2 YEAR, 2.5 YEAR AND 3 YEAR FOLLOW UP. (REF MFR # 9612164-2011-00608, 9612164-2011-00609).
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 | 52 YR | Hospitalization | CLOPIDOGREL| ASPIRIN |