It was reported that on (b)(6) 2022, a percutaneous coronary intervention was performed on the mid left anterior descending (lad) coronary artery, 99% stenosed lesion.The 3.0x8mm nc trek dilatation catheter was unable to cross the lesion due to anatomy.The device was removed with resistance due to anatomy.There was no adverse patient effect and there was no clinically significant delay.A non-abbott device was used in replacement.No additional information was provided regarding this issue.
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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 identified no other similar incidents and/or complaints from this lot.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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