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 attachment.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.The additional device referenced is being filed under a separate medwatch report number.
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Patient 2.It was reported that this patient was featured in a journal article titled, "very late scaffold thrombosis after everolimus-eluting bioresorbable scaffold implantation in patients with unremarkable interim surveillance angiography".A 3.0x28 mm absorb scaffold was implanted in the left circumflex coronary artery and a 3.0x28 absorb scaffold was implanted in the mid left anterior descending coronary artery.Per the article, six-month angiographic follow-up documented a favorable result in both lesions.514 days after the index procedure, the patient presented with st elevated myocardial infarction (stemi) and thrombotic occlusion of the bioresorbable scaffold (brs) in the left circumflex (lcx).Flow was restored after balloon dilatation and implantation of a drug eluting stent.In addition, there was diffuse in-stent restenosis in the mid left anterior descending (lad) artery brs, which was also treated with a des.No additional information was provided.
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