FDA Adverse Event
Malfunction
Summary report: N
GORE EXCLUDER AAA ENDOPROSTHESIS
MDR report key: 3221402
·
Received June 28, 2013
Report
- Report Number
- 2017233-2013-00413
- Event Type
- Malfunction
- Date Received
- June 28, 2013
- Date of Event
- May 28, 2013
- Report Date
- May 29, 2013
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- MIH
- PMA / PMN Number
- P020004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LIT MET ALL PRE-RELEASE SPECIFICATIONS.
Description of Event or Problem · 1
THE REPORT STATES THAT ON (B)(4) 2013, THE PT WAS TREATED FOR ABDOMINAL AORTA ANEURYSM USING A GORE EXCLUDER AAA ENDOPROSTHESIS. AFTER THE DEPLOYMENT OF THE CONTRALATERAL LEG ENDOPROSTHESIS, THE PHYSICIAN TRIED TO PULL BACK THE CATHETER INTO THE SHEATH AND FELT A GREAT RESISTANCE FROM THE TRAILING END. THE CATHETER BROKE IN SEVERAL PIECES. ALL PARTS OF THE CATHETER WERE REMOVED SUCCESSFULLY. THE PT TOLERATED THE PROCEDURE AND THE FINAL ANGIOGRAPHY SHOWED THAT THE DEVICES WERE INTACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 295541 | GORE EXCLUDER AAA ENDOPROSTHESIS | MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | W.L. GORE & ASSOCIATES | 10669197 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR |