(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported stent migration and difficult to remove.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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It was reported that the procedure was to treat the posterior descending artery that did not have any tortuosity or calcification.A 2.5 x 12 mm xience sierra stent delivery system (sds) was advanced to the lesion and did not meet any resistance.The balloon was fully inflated to the nominal pressure of 9 atmospheres and the stent deployed; however, the stent moved from the lesion during attempted removal of the sds.Therefore, the stent was post-dilated with the sds balloon and it moved again as the sds was attempted to be removed.The stent was then post-dilated again with the sds balloon and the stent was implanted partly in healthy tissue and partly in the lesion.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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