ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT DISTAL BIFURCATED BODY Adverse Event — Injury (MDR 9680654-2020-00017)
ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT DISTAL BIFURCATED BODY Adverse Event — Injury (MDR 9680654-2020-00017) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT DISTAL BIFURCATED BODY; Generic name: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC
| Device | ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT DISTAL BIFURCATED BODY |
|---|---|
| Generic name | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
| Manufacturer | WILLIAM A. COOK AUSTRALIA, PTY LTD |
| Report number | 9680654-2020-00017 |
| Event type | Injury |
| Product problem | N |
| Date received | 2020-04-28 |
| Report source | DISTRIBUTOR |
| Narrative | THE DELIVERY DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE APPEARED TO BE BENT AT THE TIP OF THE DEVICE, AS WELL AS AT THE CANNULA EXITING THE GREY POSITIONER. THE TOP CAP INNER CANNULA ALSO APPEARED BENT AT THE DISTAL END. ON CLOSER INSPECTION, NO DAMAGE OR STRETCH MARKS WERE VISIBLE ON THE DILATOR TIP. THE INNER CANNULA WAS BROKEN AT THE DISTAL END. THERE WERE SLIGHT MARKINGS AT THE HOLES IN TH |
| Source | openFDA MAUDE (device adverse events) |
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