One x rms-060024-r of lot c1190987 was returned to cirl for a lab evaluation.Upon analysis of the returned device, there was no encrustation noted on the stent, the stent did not appear to have any defects that could have contributed to this event, the stent was cut open on either end and a guidewire was passed through to determine if there was any blockage that may have contributed to the pain felt by the customer; there was no blockage found; the guidewire passed through the stent.It was noted during the evaluation that pain is listed as a potential adverse effect of stent placement as individual stent-body interactions are unpredictable.There was no anomaly found on the stent that could have contributed to this event.The stent was placed for three months which is within the recommended in-dwelling timeframe of 12 months.This device was used in a case of ureterostomy.The rms-060024-r devices are used for temporary stenting of the ureter in adult patients with extrinsic ureteral obstruction.These devices are intended for one-time use.It is possible that this event was attributed to the use of the stents in a patient with ureterostomies, however this cannot be conclusively determined.The customers complaint was confirmed based on customer testimony.A definitive root cause of this complaint could not be conclusively determined as device use, anatomical conditions and storage and transport conditions could not be replicated.It should be noted that the instructions for use state the following in the ¿warnings¿ section: ¿individual variations of interaction between stents and the urinary system are unpredictable¿ and " the use of this device should be based upon consideration of risk/ benefit factors as they apply to your patient" and "patients should be checked at regular intervals utilizing techniques such as abdominal x-ray (kub film).Patients using calcium supplements must be closely monitored for possible stent encrustation.The stent must be removed if encrustation hampers drainage." the customer was asked if the patient was using calcium supplementation; however to date, it is unknown if the patient was using calcium supplementation.Potential adverse events associated with indwelling ureteral stent listed on the ifu include: pain / discomfort, diminished urine drainage/ stent occlusion, stent encrustation, hydronephrosis, pyuria (due to infection).A review of the relevant manufacturing records for the rms-060024-r device of lot c1190987 did not reveal any discrepancies that could be related to this occurrence.There is no evidence to suggest that this issue affects the entire lot # c1190987; upon review of complaints this failure mode has not occurred previously with this lot # c1190987.Complaints of this nature will continue to be monitored for potential emerging trends.
|