The stents' removal as a result of the swelling of both the kidneys can be viewed as intervention - therefore this event mdr criteria of a 'serious injury' report.This complaint is related to 1 x rms-060026 device of lot#c1103858.1 x rms-060026 device of an unknown lot number was returned to cirl for evaluation.On inspection of the device the encrustation seen was considered normal and within expected level for the indwell time reported.Encrustation has been considered as a potential failure mode in the risk document.On flexing of the stent, the movement of the device was also considered normal tip of the device was cut by the senior manufacturing engineer to evaluate possible blockage of the stent.0.035¿ guide wire was inserted and safety wire removed.Guide wire could move freely and no blockage was noted.As encrustation levels based on the 5 month in-dwell in the patient were considered normal and no blockage was found within the device, a definitive root cause cannot be determined.Complaint was confirmed based on the customers¿ testimony.Prior to distribution all rms-060026 devices are subjected to visual inspection and functional checks to ensure device integrity.A review of the manufacturing records for the complaint lot and associated sub-assemblies revealed no discrepancies related to this complaint issue or occurrence.As per the instructions for use (ifu) that accompanies this device, ¿warnings¿ section: ¿individual variations of interaction between stents and the urinary system are unpredictable.Use of this device should be based on consideration of risk-benefit factors as they apply to your patient.¿ also as per the ifu ¿potential adverse events¿ associated with indwelling ureteral stents include:diminished urine drainage/stent occlusion, hydronephrosis, pain/discomfort, pyuria, stent encrustation and tissue ingrowth.It was noted in the complaint that the patient did not experience any adverse effects due to this occurrence and did not require any additional procedures.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.
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