EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - UNCOVERED Adverse Event — Injury (MDR 3005580113-2020-00356)
EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - UNCOVERED Adverse Event — Injury (MDR 3005580113-2020-00356) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - UNCOVERED; Manufacturer: COOK IRELAND LTD; Report number: 3005580113-2020-0035
| Device | EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - UNCOVERED |
|---|---|
| Manufacturer | COOK IRELAND LTD |
| Report number | 3005580113-2020-00356 |
| Event type | Injury |
| Product problem | Y |
| Date received | 2020-04-28 |
| Narrative | IT WAS FURTHER REPORTED THAT THE ISSUE OCCURRED WHEN UNPACKING OR PREPARING THE EVOLUTION, WHILE INSERTING THE EVOLUTION IN THE PATIENT, DURING STENT PLACEMENT, WHILE REMOVING THE INTRODUCER, OR DURING STENT REPOSITIONING/REMOVAL 2-3 DAYS POST PROCEDURE. FURTHERMORE, THE PATIENT WAS DISCHARGED HOME FOLLOWING PROCEDURE. THE PATIENT REPORTEDLY FELT WEAK OVER THE NEXT FEW DAYS WITH PROGRESSIVE LETHAR |
| Source | openFDA MAUDE (device adverse events) |
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