FDA Adverse Event
Injury
Summary report: N
GORE EXCLUDER AAA ENDOPROSTHESIS
MDR report key: 2170050
·
Received July 13, 2011
Report
- Report Number
- 2017233-2011-00345
- Event Type
- Injury
- Date Received
- July 13, 2011
- Date of Event
- June 6, 2011
- Report Date
- July 13, 2011
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- MIH
- PMA / PMN Number
- P020004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
ON (B)(6) 2011, THE PT UNDERWENT REPAIR OF A SACCULAR ANEURYSM. WHERE THE SACCULAR ANEURYSM WENT BACK INTO NORMAL AORTA THERE WAS STENOSIS. ON (B)(6) 2011, A FOLLOW-UP COMPUTED TOMOGRAPHY REVEALED A KINK IN THE IPSILATERAL SIDE OF THE TRUNK-IPSILATERAL LEG COMPONENT; THE IPSILATERAL LIMB THROMBOSED. THE KINKING OF THE DEVICE WAS DUE TO THE STENOSIS IN THE AORTA. THE PT IS NOT HAVING ANY PROBLEMS AND HAS DECIDED TO NOT DO ANY FURTHER PROCEDURES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GORE EXCLUDER AAA ENDOPROSTHESIS | MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | W.L. GORE & ASSOCIATES | WLG425 | 8416209 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Hospitalization| O | HYDROCHLOROTHIAZIDE| ASPIRIN| PULMICORT| COMBIVENT| LOVASTATIN |