It was reported that the procedure was to treat a heavily tortuous, heavily calcified mid left anterior descending artery that was 90% stenosed.A 2.5x12mm nc trek balloon failed to cross due to anatomy, and resistance with anatomy was also met during removal.A non-abbott balloon was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.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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