FDA Adverse Event
Injury
Summary report: N
EXCLUDER BIFURCATED ENDOPROSTHESIS
MDR report key: 559884
·
Received December 16, 2004
Report
- Report Number
- 2953161-2004-00186
- Event Type
- Injury
- Date Received
- December 16, 2004
- Date of Event
- November 15, 2004
- Report Date
- December 10, 2004
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- MIH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
DURING THE PROCEDURE TO IMPLANT THE EXCLUDER ENDOPROSTHESIS DEVICES, BLOOD LOSS IN EXCESS OF 1 LITER OCCURRED. PRIOR TO INTRODUCING THE EBE DEVICES, THE PHYSICIAN PLACED A JUMP GRAFT TO REPAIR A STENOTIC ILIAC ARTERY. DURING THIS PROCESS, HE PUSHED THE PERCLOSE DEVICE THROUGH THE ARTERY AND CREATED A LARGE HOLE, WHICH CAUSED THE BLEEDING. THE HOLE WAS SURGICALLY REPAIRED. THERE WAS NO ADVERSE OUTCOME FOR THE PT. NO ALLEGATION OF PRODUCT DEFICIENCY WAS MADE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EXCLUDER BIFURCATED ENDOPROSTHESIS | ENDOVASCULAR GRAFT SYSTEM | MIH | W.L. GORE & ASSOCIATES | WLG325 | 042400302 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Life Threatening |