(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effects of embolism, thrombosis, and surgical procedure are listed in the supera instructions for use (ifu) as a known potential patient effects.Based on the case information and related record review, a conclusive cause for the reported patient effects and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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It was reported that following pre-dilatation with a 5.0 balloon catheter for 2-3 minutes, a 4.5 supera stent was implanted in the distal popliteal lesion and following a 5.0 supera stent was implanted more proximal with some overlap.Both stents were implanted without issue with reported perfect results and both were well apposed to the vessel wall.Following, a thrombus was observed within the stents with total occlusion.The thrombus then embolized distally and a 6f catheter was used in attempt to retrieve the thrombus.During removal of the catheter through the stents, reportedly the operator did not visualize the sheath during removal and the sheath caught the 5.0 supera stent and elongated the 5.0 stent.The stents remained well apposed to the vessel wall.On (b)(6) 2018, a bypass was performed, leaving the supera stents within the patients anatomy.The patient is in stable condition without further issues reported.No additional information was provided.
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