FDA Adverse Event
Injury
Summary report: N
GORE EXCLUDER AAA ENDOPROSTHESIS
MDR report key: 2200683
·
Received July 29, 2011
Report
- Report Number
- 2953161-2011-00168
- Event Type
- Injury
- Date Received
- July 29, 2011
- Date of Event
- June 28, 2011
- Report Date
- July 28, 2011
- Manufacturer
- W. L. GORE & ASSOCIATES
- Product Code
- MIH
- PMA / PMN Number
- P020004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
METHOD: A REVIEW OF THE MANUFACTURING PAPERWORK IS BEING CONDUCTED. FURTHER INFORMATION WAS REQUESTED.
Description of Event or Problem · 1
ON (B)(6) 2011, THE PATIENT WAS IMPLANTED WITH A GORE EXCLUDER AAA ENDOPROSTHESIS FEATURING THE C3 DELIVERY SYSTEM TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED TO GORE THAT THE CONTRALATERAL GATE DID NOT OPEN ON THE PROXIMAL PART OF THE TRUNK-IPSILATERAL LEG COMPONENT, HOWEVER, IT WAS OPENED ON ITS DISTAL PART. THE PHYSICIAN WAS UNABLE TO CANNULATE THE CONTRALATERAL GATE AND DECIDED TO PERFORM AN AORTO-UNI-ILIAC (AUI) PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE. FURTHER INFORMATION WAS REQUESTED.
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 | 8531601 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Hospitalization| R |