The device was not returned for evaluation.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 did not indicate a lot specific quality issue.A conclusive cause for the reported difficulties could not be determined; however, factors that could contribute to a stretched stent include, but are not limited to, damage during manufacturing, inadvertent mishandling during sheath/stylet removal, preparation, during use of the device, interaction with accessory devices, patient anatomical morphology, or patient disease state.Material deformation may be attributed to several factors including, but are not limited to, damage during manufacturing, inadvertent mishandling during unpackaging, sheath/stylet removal, during preparation or during use of the device.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, and interaction with accessory devices.Based on the information provided and without the device to examine, a definitive cause for the reported stretched stent, material deformation and stent dislodgement cannot be determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
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