It was reported that the procedure was performed to treat a lesion in the heavily calcified and tortuous 100% stenosed right coronary artery (rca).The 2.0 x 12 mm nc trek dilatation catheter was advanced; however, resistance was noted and the sds was unable to cross.Resistance was noted during removal, related to the vessel and lesion.There was no adverse patient effect and no clinically significant delay in procedure.The procedure was completed with a non-abbott stent.No additional information was provided.
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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.Additionally, a review of the complaint history of the reported lot did not indicate a lot specific quality issue.The investigation determined the reported complaints appear to be related to operational context.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.
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