(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, myocardial infarction and restenosis, 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.The additional 3.5 x 18 mm absorb is being filed under a separate medwatch report.Attachment: 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 in-stent restenosis in two zotarolimus-eluting stents in an obtuse marginal saphenous vein graft (svg).The patient presented with unstable angina.Pre-dilatation was performed prior to implanting two 3.5 x 18 mm absorb scaffolds.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 7 months post-procedure with a myocardial infarction (mi).Restenosis was found in the distal scaffold, which was treated with a paclitaxel-eluting balloon.The patient was admitted again 15 months post-index procedure with mi and restenosis of the 2nd scaffold was found, which was treated with an everolimus-eluting metal stent.Follow-up 24 months post-index procedure, the patient was admitted again for unstable angina.Restenosis was confirmed in both lesion sites, which were treated with zotarolimus-eluting stents.No additional information was provided.
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