FDA Adverse Event
Injury
Summary report: N
GORE EXCLUDER AAA ENDOPROSTHESIS
MDR report key: 2771951
·
Received September 28, 2012
Report
- Report Number
- 3007284313-2012-00028
- Event Type
- Injury
- Date Received
- September 28, 2012
- Date of Event
- September 18, 2012
- Report Date
- September 18, 2012
- 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
FURTHER INFORMATION WAS REQUESTED. A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE IS BEING CONDUCTED. ALSO WERE IMPLANTED RMT281412/(B)(4) AND PXC UNK/UNK.
Description of Event or Problem · 1
ON (B)(6) 2012, THE PATIENT WAS IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PATIENT HAD AN EXCESSIVE TORTUOUS ANATOMY. DURING THE PROCEDURE, THE GORE EXCLUDER AAA ENDOPROSTHESIS FEATURING THE C3 DELIVERY SYSTEM MIGRATED 2CM ABOVE COVERING THE BOTH RENAL ARTERIES. THE PHYSICIAN EXPLANTED THE DEVICE IMMEDIATELY. 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 | 10291598 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 88 YR | Hospitalization| R |