Component code (annex g): g04122 ¿ stent.Pma/510(k) #: k162717.Device evaluation: the evo-20-25-12.5-e device of lot number c1574493 involved in this complaint device was not returned for evaluation.With the information and images provided document based investigation was conducted.Documents review including ifu review: prior to distribution all evo-20-25-12.5-e devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.A review of the manufacturing records for evo-20-25-12.5-e device of lot number c1574493 did not reveal any discrepancies that could have contributed to this issue.There is no evidence to suggest that this issue affects the entire lot #c1574493 ; upon review of complaints this failure mode has not occurred previously with this lot #c1574493.As per the instructions for use, ifu0061-6, which informs the user about the potential complications " additional complication include, but are not limited to: stent misplacement and/or migration; tumor ingrowth or overgrowth." there is no evidence to suggest that the customer did not follow the instructions for use.Additional information was requested to help us gain a better insight and to determine how long after implantation the stent was removed? if this information becomes available in the future then the file will be updated accordingly.As per engineering input, "i don¿t see any structural issues with the proximal stent end.It appears from the photo that due to the amount of tissue that remained it did not re-open from its withdrawal shape once outside of the body." as per medical advisor: "patient¿s discomfort was due to migration which subsequently led to occlusion" root cause review: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to patient condition related, as per instructions for use, stent migration is listed as a complication following the placement of this device.As the device was not returned for evaluation; the cause of this complaint could not be conclusively determined.Summary: according to the initial reporter, the patient outcome is unknown, removal of the stent due to migration- patient was not comfortable, as reported.Customer complaint is confirmed based on customer testimony and images provided.Complaints of this nature will continue to be monitored for potential emerging trends.
|