(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant medical products: stent: resolute integrity 2.5x30mm, 3.0x38mm; xience xpedition 3.0x8mm.The device was not returned for evaluation.However, ischemia and death are listed in the xience xpedition everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined.A review of the lot history record and complaint history of the reported device could not be conducted because the lot number was not provided.There is no indication of a product quality issue with respect to manufacture, design or labeling.The xience xpedition 3.0x8mm is filed under a separate medwatch report number.
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It was reported that the procedure was to treat lesions located in the left main and proximal left anterior descending coronary arteries on (b)(6) 2016.After ablation was performed with a non-abbott device, a perforation occurred.Non-abbott stents were implanted to treat the perforation.Then, two xience xpedition (3.0 x 38 mm and 3.0 x 8 mm) stents were implanted.After implantation of the xience xpedition stents, blood flow was decreased and the patient's condition changed for the worse.In spite of intra-aortic balloon pump (iabp) and percutaneous cardio pulmonary support (pcps) followed by coronary artery bypass graft (cabg), on (b)(6) 2016, the patient expired.The cause of death was reported as heart failure due to the decreased blood flow caused by plaque, however it could not be confirmed when the plaque shift occurred; after implant of one or both stents.No additional information can be provided.
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