It was reported that on (b)(6) 2015 a 2.25x18 mm xience xpedition stent was implanted in the mid right coronary artery (rca) and a 2.5x18 mm absorb scaffold were successfully implanted in the mid left circumflex coronary artery (lcx).On (b)(6) 2016, the patient experienced shortness of breath.Medication was prescribed.On (b)(6) 2017, the patient had typical exertional angina.Medications were prescribed.Percutaneous coronary intervention was performed on (b)(6) 2017 where 100% in-stent restenosis was found in the lcx and less than 50% in-stent restenosis was found in the rca.Stenting was performed in the lcx and in the ramus artery to treat 70% stenosis.The rca was not treated.The patient was discharged in stable condition.No additional information was provided.
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Internal file number - (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 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.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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