FDA Adverse Event
Injury
Summary report: N
GORE EXCLUDER AAA ENDOPROSTHESIS
MDR report key: 3212742
·
Received July 2, 2013
Report
- Report Number
- 2017233-2013-00427
- Event Type
- Injury
- Date Received
- July 2, 2013
- Date of Event
- June 27, 2013
- Report Date
- June 27, 2013
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- MIH
- PMA / PMN Number
- P020004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
ON (B)(6) 2013, PT WAS IMPLANTED WITH A GORE EXCLUDER AAA ENDOPROSTHESIS FEATURING THE C3 DELIVERY SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE DEVICE WAS IMPLANTED WITHOUT ANY COMPLICATIONS. AFTER THE PROCEDURE, A COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) SHOWED THAT THE IPSILATERAL LEG WAS CONCLUDED. ON (B)(6) 2013, THE PHYSICIAN RE-INTERVENED USING A FOGARTY CATHETER TO REMOVE THE OCCLUSION. ALSO, THE LEFT LEG OF THE TRUNK-IPSILATERAL LEG COMPONENT WAS EXTENDED PROXIMALLY WITH AN ILIAC EXTENDER COMPONENT. THE PT TOLERATED THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 301382 | GORE EXCLUDER AAA ENDOPROSTHESIS | MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | W.L. GORE & ASSOCIATES | 11241798 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Hospitalization| R |