AFX Adverse Event — Injury (MDR 2031527-2020-00141)
AFX Adverse Event — Injury (MDR 2031527-2020-00141) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: AFX; Generic name: BIFURCATED STENT GRAFT; Manufacturer: ENDOLOGIX.
| Device | AFX |
|---|---|
| Generic name | BIFURCATED STENT GRAFT |
| Manufacturer | ENDOLOGIX |
| Report number | 2031527-2020-00141 |
| Event type | Injury |
| Product problem | N |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | THE MANUFACTURING LOT REVIEW CONFIRMED ALL DEVICES MET SPECIFICATIONS PRIOR TO RELEASE. THE DEVICES WERE NOT RETURNED AS THEY REMAIN IMPLANTED, AND THEREFORE NO SAMPLE EVALUATION WAS COMPLETED. A CLINICAL EVALUATION OF THE REPORTED EVENT COULD NOT BE COMPLETED DUE TO A LACK OF RECEIPT OF RELEVANT MEDICAL RECORDS AND/OR IMAGING; SEVERAL REQUESTS WERE MADE ON AND NO RESPONSE WAS RECEIVED. AS SUCH, T |
| Source | openFDA MAUDE (device adverse events) |
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