(b)(4).There was no reported device malfunction and the product was not returned as the scaffold remains in the anatomy.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.The reported patient effects of angina and thrombosis, as listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use are known adverse events associated with the use of a coronary scaffold in native coronary arteries.Based on the case information, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.Article titled, everolimus-eluting bioresorbable vascular scaffold implantation to treat saphenous vein graft disease,single-center initial experience.
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Information received via article titled: "everolimus-eluting bioresorbable vascular scaffold implantation to treat saphenous vein graft disease,single-center initial experience." it was reported that the procedure was to treat a de novo lesion in the saphenous vein graft (svg) in the right coronary artery.The patient presented with unstable angina.Pre-dilatation was performed and a 3.5 x 28 mm absorb scaffold was implanted at 12 atmospheres.Post-dilatation was performed with a 3.5 mm balloon to successfully complete the procedure.The patient was discharged on dual antiplatelet therapy of ticagrelor and aspirin.The patient was readmitted 20 months' post-procedure due to unstable angina.Angiography confirmed a thrombosis occlusion in the scaffold, which was treated with medication.Follow-up on the patient confirmed no further ischemia driven event.No additional information was provided.
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