(b)(4).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.A cine was received and reviewed by an abbott vascular clinical specialist.The reviewer concluded that only the initial angios from (b)(6) 2016 were provided.Ivus images for this date and angios from the event date, (b)(6) 2016 were not provided.Quality of the angios and vessel overlap make localizing the proximal scaffold markers a challenge, but the proximal diagonal is under-expanded.Under-expansion of the scaffold or leaving the proximal vessel untreated and under-expanded may predispose this area to thrombosis formation.The reported patient effects of angina and thrombosis, as listed in the absorb gt1 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.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
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