FDA Adverse Event
Injury
Summary report: N
EXCLUDER BIFURCATED ENDOPROSTHESIS
MDR report key: 473716
·
Received July 23, 2003
Report
- Report Number
- 2953161-2003-00021
- Event Type
- Injury
- Date Received
- July 23, 2003
- Date of Event
- March 13, 2003
- Report Date
- July 22, 2003
- Manufacturer
- W.L. GORE & ASSOCIATES, INC.
- Product Code
- MIH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
RIGHT FEMORAL CUTDOWN APPROACH ATTEMPTED;' RENAL DILATORS AND TWO 18FR SHEATH DILATORS USED TO ATTEMPT ACCESS UNSUCCESSFULLY. SWITCHED TO AN EXTERNAL ILIAC CONDUIT APPROACH. DUE TO CALCIFICATION AND SMALL SIZE OF THE VESSEL, THE CONDUIT PROCEDURE WAS VERY DIFFICULT AND RESULTED IN AN ESTIMATED BLOOD LOSS OF 1000CC, 700 OF WHICH WERE RETURNED VIA CELL SAVER. ACCESS WAS EVENTUALLY ACHIEVED AND THE EXCLUDER BIFURCATED ENDOPROSTHESIS (EBE) PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS EVENT OCCURRED PRIOR TO THE INTRODUCTION OF ANY OF THE EBE COMPONENTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EXCLUDER BIFURCATED ENDOPROSTHESIS | ENDOVASCULAR GRAFT SYSTEM | MIH | W.L. GORE & ASSOCIATES, INC. | WLG325 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Required Intervention |