FDA Adverse Event
Injury
Summary report: N
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
MDR report key: 2092743
·
Received May 10, 2011
Report
- Report Number
- 9612164-2011-00386
- Event Type
- Injury
- Date Received
- May 10, 2011
- Date of Event
- March 31, 2011
- Report Date
- April 11, 2012
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- NIQ
- PMA / PMN Number
- P060033
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
A 2.75MM DIAMETER X 14 MM LENGTH ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG ELUTING CORONARY STENT, WAS DEPLOYED IN THE RAMUS INTERMEDIUS OF A PT. STENT IMPLANT WAS SUCCESSFUL; HOWEVER IT WAS REPORTED THAT THE PT SUFFERED AN MI TWO DAYS POST IMPLANT OF THE RELEVANT STENT. INVESTIGATOR REPORTED THAT THE EVENT WAS POSSIBLY RELATED TO THE STUDY STENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDEAVOR SPRINT RX CORONARY STENT SYSTEM | NIQ | MEDTRONIC IRELAND | NA | 0001136058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Hospitalization | ASA| NITRATE| LIPID LOWERING DRUG| CLOPIDOGREL| ANGIOTENSIN| CA++ ANTAGONIST| BETA |