FDA Adverse Event
Injury
Summary report: N
EXPORT AP ASPIRATION CATHETER
MDR report key: 9155319
·
Received October 4, 2019
Report
- Report Number
- 1220452-2019-00134
- Event Type
- Injury
- Date Received
- October 4, 2019
- Date of Event
- January 5, 2019
- Report Date
- October 4, 2019
- Manufacturer
- MEDTRONIC, INC
- Product Code
- DXE
- PMA / PMN Number
- K120808
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
EXPORT ASPIRATION CATHETER DEVICES WERE USED AS PART OF A STUDY TO COMPARE THE EFFECT OF LOCALIZED AND INTRACORONARY INJECTION OF EP TIFIBATIDE ON MYOCARDIAL PERFUSION IMPROVEMENT AND ITS OUTCOMES. MANUAL THROMBUS ASPIRATION WAS PERFORMED WITH THE EXPORT IN ALL CASES. IN SOME CASES TWO BOLUS DOSES OF 180 G/KG EPTIFIBATIDE WERE ADMINISTERED THROUGH THE GUIDE CATHETER WHILE IN OTHER CASES IT WAS ADMINISTERED THROUGH THE EXPORT DEVICE AND INTO THE LESION DIRECTLY. END POINTS OF THE STUDY WERE DEATH, CARDIAC ARRHYTHMIA, STROKE, ACUTE MYOCARDIAL INFARCTION AND GASTROINTESTINAL BLEEDING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 951173 | EXPORT AP ASPIRATION CATHETER | CATHETER, EMBOLECTOMY | DXE | MEDTRONIC, INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Hospitalization| R |