FDA Adverse Event
Injury
Summary report: N
GORE EXCLUDER AAA ENDOPROSTHESIS
MDR report key: 2122957
·
Received June 7, 2011
Report
- Report Number
- 2017233-2011-00267
- Event Type
- Injury
- Date Received
- June 7, 2011
- Date of Event
- May 20, 2011
- Report Date
- June 6, 2011
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- MIH
- PMA / PMN Number
- P020004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE MFG PAPERWORK IS BEING CONDUCTED. FURTHER INFO WAS REQUESTED.
Description of Event or Problem · 1
ON (B)(6) 2011, THE PT WAS IMPLANTED WITH A GORE EXCLUDER AAA ENDOPROSTHESIS FEATURING THE C3 DELIVERY SYS TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED TO GORE THAT THE DEVICE WAS CORRECT IMPLANTED, BUT THE PHYSICIAN HAD A DIFFICULTY TO CANNULATE THE CONTRALATERAL GATE. THE DECISION WAS MADE TO DO A CROSSOVER PROCEDURE. DURING THIS PROCEDURE, THE DEVICE SLID DOWN INTO THE ANEURISMAL SAC AND THEY WERE UNABLE TO REPOSITION IT. THE PHYSICIAN DECIDED TO CONVERT THE PT TO OPEN SURGICAL PROCEDURE. THE PT TOLERATED THE PROCEDURE. FURTHER INFO WILL BE PROVIDED.
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 | 8838162 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Hospitalization| R |