FDA Adverse Event
Injury
Summary report: N
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
MDR report key: 2023334
·
Received March 16, 2011
Report
- Report Number
- 9612164-2011-00059
- Event Type
- Injury
- Date Received
- March 16, 2011
- Date of Event
- March 4, 2008
- Report Date
- February 16, 2011
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- NIQ
- PMA / PMN Number
- P060033
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVALUATION: RESULTS: (MI).
Description of Event or Problem · 1
PATIENT RECEIVED A 4.0MM DIAMETER X 30MM LENGTH ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG ELUTING CORONARY STENT IN THE PROX RCA DURING INDEX PROCEDURE. EVENT WAS IDENTIFIED BY THE CLINICAL EVENTS COMMITTEE AND DEEMED TO BE CONSISTENT WITH AN MI. IT WAS REPORTED THAT A PERIPROCEDURAL MI EVENT OCCURRED. MI WAS CATEGORIZED TO BE A NON Q-WAVE MI IN THE TERRITORY OF THE IMPLANTED STENT. NO FURTHER DETAILS ARE AVAILABLE.
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 | 56 YR | CLOPIDOGREL| ASPIRIN |