(b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.Implant date has been estimated.The device was not returned for evaluation.A review of the lot history record could not be performed as the lot number was not provided.The reported patient effect of stenosis is listed in the xience xpedition, ce eluting coronary stent systems (eccs) instructions for use, as a known patient effect.A conclusive cause for the reported patient effect and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The additional xience xpedition device is being file under a separate medwatch report.
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It was reported that in (b)(6) 2018, the procedure was performed using two xience xpedition stents to treat a lesion in the mid right coronary artery (rca) with mild calcification.A 3.0 x 38 mm xience xpedition stent was implanted in the proximal rca and a 3.0 x 18 mm xience xpedition stent was implanted in the mid rca.On (b)(6) 2018, the patient presented with acute coronary syndrome from a de novo blockage.Angiography revealed the stents had 70-80% restenosis in the rca in both xience xpedition stents.Balloon angioplasty was performed to treat the restenosis.Per the physician, the cause of the restenosis was under expansion of the stent.The left anterior artery was also treated.No additional information was provided.
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