(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.The investigation was unable to determine a conclusive cause for the reported difficulties.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 identified no similar incidents from this lot.The reported patient effect of dissection is listed in the xience xpedition everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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It was reported that the procedure was to treat a de novo, 80% stenosed lesion in the heavily tortuous mid left anterior descending coronary artery.During deployment of the 2.5x18 mm xience xpedition stent, the stent moved slightly from the intended position, causing a minor dissection in the arterial wall.The stent remained inside the target lesion.A new same size xience xpedition stent was used to cover the dissection.There were no adverse patient sequela and there was no reported clinically significant delay in the procedure.No additional information was provided.
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