As reported to customer relations via cir complaint form "as reported to customer relations via cir complaint form "on 13jan2020 the device was placed due to chronic hydronephrosis via cystoscopy with retrograde pyelogram.Placement was confirmed via fluoroscopy.Device was removed emergently on (b)(6) 2020 due to complication of stent dislodgement and encrustation and was a device deficiency.Site stated ¿emergent procedure for dislodgement and heavily calcified metal stent.Thick, purulent effluvium released after new stent placed." (b)(4) captures the encrustation and this complaint captures the stent dislodgement patient outcome: there is data is still pending with multiple queries.Site states there were adverse events involving the study device but has not entered the adverse event data.Patient/event info - notes: no manufacture additional questions were asked as this is a cri pmcf study complaint.-(b)(4) 09jan2024.
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