AFX2 Adverse Event — Injury (MDR 2031527-2020-00144)
AFX2 Adverse Event — Injury (MDR 2031527-2020-00144) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: AFX2; Generic name: BIFURCATED STENT GRAFT; Manufacturer: ENDOLOGIX.
| Device | AFX2 |
|---|---|
| Generic name | BIFURCATED STENT GRAFT |
| Manufacturer | ENDOLOGIX |
| Report number | 2031527-2020-00144 |
| Event type | Injury |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | CLINICAL ASSESSMENT WAS COMPLETED BASED ON THE RECEIVED MEDICAL RECORDS. THE REPORTED TYPE IIIA ENDOLEAK (AORTIC) WITH COMPLETE COMPONENT SEPARATION WAS CONFIRMED. ADDITIONALLY, IT WAS DETERMINED THAT THERE WAS EVIDENCE TO REASONABLE SUGGEST AN AORTIC RUPTURE OCCURRED THAT WERE NOT INCLUDED IN THE EVENT AS REPORTED. THE CONTRIBUTING FACTORS FOR THE REPORTED TYPE IIIA ENDOLEAK COULD NOT BE DETERMIN |
| Source | openFDA MAUDE (device adverse events) |
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