AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PROFILE) Adverse Event — Injury (MDR 3013164176-2020-00060)
AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PROFILE) Adverse Event — Injury (MDR 3013164176-2020-00060) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PROFILE); Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT; Manufacturer
| Device | AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PROFILE) |
|---|---|
| Generic name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
| Manufacturer | W.L. GORE & ASSOCIATES |
| Report number | 3013164176-2020-00060 |
| Event type | Injury |
| Product problem | N |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE |
| Narrative | (B)(4). ACCORDING TO THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), INDICATIONS FOR USE OF THE CONTRALATERAL LEG ENDOPROSTHESIS COMPONENT INCLUDES APPROPRIATE ANATOMY INCLUDING, BUT NOT LIMITED TO, ILIAC ARTERY TREATMENT DIAMETER RANGE OF 8 ¿ 25MM AND ILIAC DISTAL VESSEL SEAL ZONE LENGTH OF AT LEAST 10 MM. |
| Source | openFDA MAUDE (device adverse events) |
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