(b)(4).Concomitant devices: aspirin, p2y12, four absorb bvss (3.0x18, 3.5x28, [two] 3.5 x 12s).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 identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effects of angina 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 and related record review, a conclusive cause for the reported patient effects and the relationship to the product, if any, cannot be determined and there is no indication of a product quality issue with respect to design, manufacture or labeling of the device.The absorb device is currently not commercially available in the u.S; however, it is similar to a device sold in the us.
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It was reported that on (b)(6) 2014 five absorb scaffolds (sizes 3.0x18, 3.0x28, 3.5x12, 3.5x28, 3.5x12) were implanted in the first diagonal coronary artery, mid left anterior descending coronary artery (lad), and the proximal lad.On (b)(6) 2017 the patient experienced recurrent chest pain (stable angina) and shortness of breath.Medications were given and percutaneous coronary intervention with stent placement was performed.The condition resolved on (b)(6) 2017.No additional information was provided.
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