FDA Adverse Event
Injury
Summary report: N
EXCLUDER BIFURCATED ENDOPROSTHESIS
MDR report key: 521871
·
Received April 21, 2004
Report
- Report Number
- 2025240-2004-00006
- Event Type
- Injury
- Date Received
- April 21, 2004
- Report Date
- April 20, 2004
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- MIH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NZ
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
DURING THE PROCEDURE TO IMPLANT THE EXCLUDER BIFURCATED ENDOPROSTHESIS, THE FINAL ANGIOGRAM INDICATED A TYPE I, PROXIMAL, ENDOLEAK. THE LEAK PERSISTED EVEN AFTER IT WAS BALLOONED TWICE. THE PHYSICIANS DECIDED THAT THE DEVICE SHOULD BE LEFT AND MONITORED. REPEAT SCANNING INDICATED THAT THE LEAK PERSISTED. THE SURGEON SURGICALLY REMOVED THE EBE AND REPAIRED THE ANEURYSM SURGICALLY. THE PT IS STABLE AND RECOVERING. THE SURGEON SUSPECTS THAT THE PT'S ANATOMY CAUSED THIS PROBLEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EXCLUDER BIFURCATED ENDOPROSTHESIS | ENDOVASCULAR GRAFT SYSTEM | MIH | W.L. GORE & ASSOCIATES | WLG325 | 01894797 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Required Intervention |