(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 identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history of the reported lot did not indicate a lot specific quality issue.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely the device interacted with the guiding catheter extension during insertion causing the stent to move on the balloon (unstable stent).There is no indication of a product quality issue with respect to manufacture, design or labeling.
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It was reported that during the attempt to insert the 3.5 x 18 mm xience alpine stent delivery system (sds) into the guide catheter extension, resistance was felt which caused the stent to move on the balloon; however, the stent implant was still on the balloon.The sds was removed from the guide catheter and replaced with a new sds which was used successfully for the case.No adverse patient effects or clinically significant delay in the procedure were reported.No additional information was provided.
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