(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.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, as listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use (ifu), 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.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
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It was reported that on (b)(6) 2013, a 2.5x18mm absorb bioresorbable vascular scaffold (bvs) was successfully implanted in the proximal circumflex (cx) coronary artery lesion.On (b)(6) 2018, the patient started experiencing unstable chest pain and on (b)(6) 2018, the patient was hospitalized for this chest pain.Medication was provided and an electrocardiogram was performed without positive results reported.The symptoms resolved and the patient was discharged from hospital.Reportedly, there was no obvious cause for this chest pain.No additional information was provided regarding this issue.
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