It was reported that during a procedure to treat a de novo lesion in the distal left anterior descending (lad) artery with mild tortuosity and moderate calcification, pre-dilatation was performed.A 2.5x38 mm rx xience xpedition stent delivery system was advanced and the stent was deployed; however, an edge dissection at the proximal portion of the stent occurred.Another 2.75x18 mm xience xpedition stent was implanted to treat the dissection.There was no adverse patient sequelae and there was no reported clinically significant delay in the procedure.No additional information was provided.
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(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.There was no reported device malfunction and the product was not returned.The reported patient effect of dissection, as listed in the xience xpedition everolimus eluting coronary stent system instructions for use is a known patient effect that may be associated with use of a coronary stent in native coronary arteries.Although a conclusive cause for the reported patient effects, and the relationship to the product, if any, could not be determined, there is no indication of a product quality deficiency with respect to manufacturing, design or labeling.
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