(b)(4).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 lot number was not provided.The reported patient effects of angina and restenosis, as listed in the absorb gt1 instructions for use (ifu), 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 the treatment appears to be related to the circumstances of the procedure.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) 2016, following pre-dilatation with a 2.75mm trek dilatation catheter, a 3.0x28mm absorb bioresorbable vascular scaffold (bvs) was implanted in the mid left anterior descending (lad) coronary artery lesion.Post dilatation was performed using a 3.25x20mm trek catheter.On (b)(6) 2018, restenosis was noted at the bvs site and the patient experienced associated angina, class 3.Another percutaneous procedure was performed as treatment.A non-abbott stent was implanted as treatment at the bvs restenosed site.There was no additional information provided regarding this issue.
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