It was reported that on (b)(6) 2013, the patient underwent a coronary procedure, with implantation of a 2.5 x 18 mm absorb bioresorbable vascular scaffold (bvs) in the distal right coronary artery.In (b)(6) 2017, the patient experienced angina and was re-hospitalized.Medication was administered and the patient condition continued.No additional information was provided.
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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 effect of angina, as listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use is a known adverse event 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.
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