FDA Adverse Event
Injury
Summary report: N
GORE® EXCLUDER® AAA ENDOPROSTHESIS
MDR report key: 6194216
·
Received December 21, 2016
Report
- Report Number
- 3007284313-2016-00260
- Event Type
- Injury
- Date Received
- December 21, 2016
- Date of Event
- December 3, 2016
- Report Date
- December 3, 2016
- Manufacturer
- W.L. GORE & ASSOCIATES
- Product Code
- MIH
- PMA / PMN Number
- P020004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
LOT 15098011: (B)(4). (B)(6). (B)(4).
Description of Event or Problem · 1
ON (B)(6) 2016, THE PATIENT WAS IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THE PATIENT WAS HAVING PAIN IN THE RIGHT LEG AND A COMPUTED TOMOGRAPHY SCAN (CT) WAS DONE ON (B)(6) 2016. THE PHYSICIAN DIAGNOSED THE RLT231418/15098011 HAD BECOME THROMBOSED IN THE IPSILATERAL LIMB. A REINTERVENTION WAS DONE AND THE PHYSICIAN PERFORMED AN EMBOLECTOMY TO RESTORE BLOOD FLOW. ON (B)(6) 2016, THE PHYSICIAN IMPLANTED AN ADDITIONAL GORE EXCLUDER AAA ENDOPROSTHESES. THE PATIENT TOLERATED THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 846636 | GORE® EXCLUDER® AAA ENDOPROSTHESIS | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | W.L. GORE & ASSOCIATES | 15098011 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Hospitalization| R |