FDA Adverse Event
Malfunction
Summary report: N
GORE EXCLUDER AAA ENDOPROSTHESIS
MDR report key: 2946245
·
Received January 4, 2013
Report
- Report Number
- 2953161-2013-00002
- Event Type
- Malfunction
- Date Received
- January 4, 2013
- Date of Event
- December 13, 2012
- Report Date
- December 14, 2012
- Manufacturer
- W. L. GORE & ASSOCIATES, INC.
- Product Code
- MIH
- PMA / PMN Number
- P020004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
RESULT - THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECS.
Description of Event or Problem · 1
ON (B)(6) 2012, THIS PT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE EXCLUDER AAA ENDOPROSTHESES. AFTER DEPLOYMENT OF THE TRUNK-IPSILATERAL LEG COMPONENT, THE PHYSICIAN PLACED THE CONTRALATERAL LEG COMPONENT INTO THE CONTRALATERAL GATE AND DEPLOYED THE COMPONENT. AFTER REMOVING THE DELIVERY CATHETER, IT WAS NOTICED THAT THE LEADING END OF THE CATHETER HAD DISCONNECTED FROM THE REST OF THE DELIVERY CATHETER. A SNARE WAS USED TO RETRIEVE THE FRAGMENT FROM THE LEFT COMMON ILIAC ARTERY. THE PT TOLERATED THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 5900 | GORE EXCLUDER AAA ENDOPROSTHESIS | MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | W. L. GORE & ASSOCIATES, INC. | 10800717 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR |