It was reported that in (b)(6) 2016, an absorb gt1 scaffold was implanted.In (b)(6) 2017, the patient was experiencing some symptoms similar to symptoms experienced prior to implantation of the scaffold.There may be restenosis in the scaffold and the patient may be experiencing chest pain.Treatment is being considered, but has not been reported as yet.There was no additional information provided.
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(b)(4).In the absence of reported part number, di cannot be calculated.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 and complaint history of the reported lot could not be conducted because the part and lot numbers were not provided.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.
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