FDA Adverse Event
Injury
Summary report: N
ENDEAVOR SPRINT OTW CORONARY STENT SYSTEM
MDR report key: 2210466
·
Received August 8, 2011
Report
- Report Number
- 9612164-2011-00887
- Event Type
- Injury
- Date Received
- August 8, 2011
- Date of Event
- March 4, 2011
- Report Date
- July 13, 2011
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- NIQ
- PMA / PMN Number
- P060033
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVALUATION, RESULTS: (GI BLEED).
Description of Event or Problem · 1
AN ENDEAVOR SPRINT OVER THE WIRE (OTW) DRUG ELUTING STENT WAS IMPLANTED IN THE MID LAD DURING INDEX PROCEDURE. IT IS REPORTED THAT APPROXIMATELY 2 MONTHS POST INDEX PROCEDURE THE PT SUFFERED A SPONTANEOUS GASTROINTESTINAL (GI) BLEED. IT IS REPORTED THAT THERE WAS AN UPPER ENDOSCOPY CARRIED OUT WITH CAUTERIZATION. INVESTIGATOR HAS INDICATED THAT EVENT WAS NOT RELATED TO STUDY STENT OR PROCEDURES. PT WAS TAKING ASPIRIN & CLOPIDOGREL 24 HOURS PRIOR TO THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDEAVOR SPRINT OTW CORONARY STENT SYSTEM | NIQ | MEDTRONIC IRELAND | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Required Intervention |