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 failure to advance and difficulty removing the device 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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It was reported that the procedure was to treat a lesion located in and the right coronary artery that was heavily calcified, mildly tortuous and 90% stenosed.The mini trek rx was advanced toward the lesion, but resistance was felt and the device failed to reach the lesion.Resistance was noted during removal of the device.A non-abbott balloon was used to complete the procedure.There was no reported adverse patient effect and no clinically significant delay in the procedure.No additional information was provided.
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