FDA Adverse Event
Injury
Summary report: N
GORE EXCLUDER AAA ENDOPROSTHESIS
MDR report key: 1881106
·
Received October 20, 2010
Report
- Report Number
- 2017233-2010-00466
- Event Type
- Injury
- Date Received
- October 20, 2010
- Date of Event
- October 8, 2010
- Report Date
- October 20, 2010
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- MIH
- PMA / PMN Number
- P020004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
ON (B)(6) 2010, THE PT WAS TREATED FOR A 7.2 CM DIAMETER ABDOMINAL AORTIC ANEURYSM WITH GORE EXCLUDER AAA ENDOPROSTHESES. THE TRUNK DEPLOYED AS INTENDED, AND WAS FULLY OPEN. THE PHYSICIAN WAS UNABLE TO CANNULATE THE GATE, HOWEVER. THE INABILITY TO CANNULATE WAS ATTRIBUTED TO A NARROW DISTAL NECK AND TORTUOUS ILIAC ARTERIES. THE IPSILATERAL LIMB OF THE TRUNK WAS CROSSED SUCH THAT IT HINDERED ACCESS TO THE GATE, AND ALSO PREVENTED SNARING OF THE WIRE THROUGH BRACHIAL ACCESS. AFTER OVER TWO HOURS OF ATTEMPTS TO CANNULATE, THE PHYSICIAN CONVERTED THE PT TO OPEN REPAIR. THE PT TOLERATED THE PROCEDURE.
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 | WLG325 | 8011928 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Hospitalization| R |