A visual and dimensional inspection was performed on the returned device.The reported stent dislodgement was confirmed.Production record and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint handling database identified no similar complaints from this lot.A conclusive cause for the reported dislodgement could not be determined; however, stent dislodgement may be attributed to several factors including, but not limited to, improper or inadequate crimping at the time of manufacture, incorrect sheath sizing, positive pressure during preparation, forced sheath removal, handling of the stent during preparation, interaction with the anatomy, or interaction with accessory devices.In this case, it is possible that inadvertent mishandling during sheath/stylet removal and/or during preparation of the device may have contributed to the reported stent dislodgement in addition to the observed material deformation (stent damage); however, this cannot be confirmed.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
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