The date of event has been estimated.The date of implant has been estimated.The device was not returned for analysis.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot and part number were not provided.A conclusive cause for the difficulties listed can not be determined based on the limited information available.The patient effects listed are consistent with the product risk profile and are therefore expected.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.Literature: article title: very late scaffold thrombosis after everolimus-eluting bioresorbable scaffold implantation in patients with unremarkable interim surveillance angiography.The udi number is unknown as the part and lot #s were not provided.
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Patient 3.It was reported that this patient was featured in a journal article titled, "very late scaffold thrombosis [vlsct] after everolimus-eluting bioresorbable scaffold implantation in patients with unremarkable interim surveillance angiography".Two 2.5 mm absorb scaffolds and a total length of 36 mm were implanted in the right coronary artery.Angiographic follow-up confirmed favorable results.702 days after the index procedure, the patient presented with vlsct and thrombotic occlusion of the distal scaffold, which was treated with balloon dilatation and drug eluting stent implantation.No additional information was provided.
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