(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.The reported patient effects of angina and thrombosis, as listed in the absorb gt1 instructions for use, are known adverse events associated with the use of a coronary scaffold in native coronary arteries.A cine was received and reviewed by an abbott vascular clinical specialist.It was confirmed that stent thrombosis is documented by optical computed tomography (oct) in a deployed absorb scaffold with strut mal-apposition at the proximal end.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 manufacture, design or labeling.
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