AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PERM) Adverse Event — Injury (MDR 2017233-2020-00275)
AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PERM) Adverse Event — Injury (MDR 2017233-2020-00275) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PERM); Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT; Manufacturer: W.L. GO
| Device | AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PERM) |
|---|---|
| Generic name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
| Manufacturer | W.L. GORE & ASSOCIATES |
| Report number | 2017233-2020-00275 |
| Event type | Injury |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE |
| Narrative | MEDWATCH REPORT #2017233-2020-00276 REFERENCES THE SAME PATIENT AND CAPTURES THE REPORTED PROXIMAL TYPE I ENDOLEAK AND ANEURYSM ENLARGEMENT. (B)(4). A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. PER THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BU |
| Source | openFDA MAUDE (device adverse events) |
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