PROPEL sinus implants for maintaining sinus patency after surgery

Regulatory information

PROPEL is a CE marked class III medical device.

Thirty-four alerts were identified on the MAUDE database. A number appear to be duplicate reports for the same intervention, and not all could be clearly attributed to the device. The most common issue reported was migration or expulsion of the device, in 2 instances into the throat. There were also multiple reports of fungal infections and fungus on the device.