It was reported that on (b)(6) 2014, the patient presented with a non-st elevated myocardial infarction.A 2.5x18mm and a 3.0x28mm absorb bioresorbable vascular scaffold (bvs) were successfully implanted in the proximal circumflex (cx) coronary artery lesion.On (b)(6) 2017, the patient was hospitalized due to breathlessness and chest tightness.Per diagnostic angiogram, there was mild to moderate lesion in the posterior diagonal coronary artery and a diffuse plaque in the cx.The cx had an aneurysmal appearance which had improved and was not increasing in size.Coronary disease was also noted in the proximal left anterior descending, with an intramyocardial muscle bridge.The first diagonal coronary artery contained moderate coronary disease.The event resolved and the patient is to be reviewed in the cardiology clinic.There was no additional information provided regarding this issue.
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(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, aneurysm, and restenosis, as listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use (ifu) 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 the treatment appears to be related to the circumstances of the procedure.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
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