(b)(4).Attempts were made to obtain complete event, patient and device information.The device was not returned for evaluation.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 thrombosis, as listed in the absorb gt1 bioresorbable vascular scaffold (bvs) system, instructions for use, are known adverse events associated with the use of a coronary scaffold in native coronary arteries.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 the design, manufacture or labeling of the device.The absorb gt1 2.5x18 referenced is filed under a separate medwatch report number.
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It was reported that on (b)(6) 2016, two absorb scaffolds, sizes 2.5x18 and 3.0x28, were implanted, using visual assessment, in the mid to distal left anterior descending coronary artery.On (b)(6) 2017, the patient presented with chest pain and ekg changes.The two scaffolds were noted to be thrombosed at the site of overlap.A non-abbott stent was implanted as treatment and the condition resolved.There was no reported adverse patient sequela.No additional information was provided.
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