The production traveler (dhr) was reviewed and no issues were found.All devices in this lot met the criteria for release and distribution.There are no other associated complaints with this lot of devices or with the components used on the devices.The d'vill introducer that the device was being used with was not returned for evaluation, so it was unable to be determined what cause the stent to become dislodged within the sheath.The complaint stent and bib were returned to numed for investigation.The stent is no longer crimped down on the bib.The covering was completely detached from the stent and not returned.The stent has been flattened at one end.The od of the stent at the flattened end is 0.194" at its widest point and 0.108" at its narrowest point.The other end of the stent had an od of 0.143".The id of the 12fr introducer is 0.154".It is unknown as to when the stent became flattened, before or after removal from the sheath.The zigs at each end of the stent were overlapped.The condition of the stent and the lack of access to the introducer used during the procedure make it impossible to recreate the complaint.
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