FDA Adverse Event
Injury
Summary report: N
ENDEAVOR RX CORONARY STENT SYSTEM
MDR report key: 1083005
·
Received July 28, 2008
Report
- Report Number
- 2953200-2008-00608
- Event Type
- Injury
- Date Received
- July 28, 2008
- Date of Event
- November 26, 2007
- Report Date
- June 27, 2008
- Manufacturer
- MEDTRONIC CARDIOVASCULAR GALWAY
- Product Code
- NIQ
- PMA / PMN Number
- P060033
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
SECONDARY INTERVENTION - EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (HEMORRHAGE REQUIRING TRANSFUSION).
Description of Event or Problem · 1
ONE ENDEAVOR STENT (2.75 X 14MM) WAS IMPLANTED TO THE PROXIMAL LAD. THE PATIENT SUFFERED SPONTANEOUS GASTROINTESTINAL BLEEDING ON THREE DAYS POST STENT IMPLANT. THE INVESTIGATOR REPORTED THAT THE EVENT WAS NOT RELATED TO THE STUDY STENT. PRBC TRANSFUSION CARRIED OUT. PATIENT WAS REPORTED TO BE ASYMPTOMATIC AT THE 30 DAY & 6 MONTH FOLLOW UP. PLEASE NOTE THAT THIS DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDEAVOR RX CORONARY STENT SYSTEM | NIQ | MEDTRONIC CARDIOVASCULAR GALWAY | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention | CLOPIDOGREL - 24 HRS PRIOR TO THE EVENT| ASA - 24 HRS PRIOR TO THE EVENT| TICLOPIDINE - 24 HOURS PRIOR TO THE EVENT |