It was reported that the procedure was to treat a lesion located in the proximal left anterior descending coronary artery that was non-tortuous, moderately calcified and 70% stenosed.The xience sierra stent was successfully deployed at 16 atmospheres for 20 seconds; however, during deployment, it was noted that the proximal segment of the balloon appeared elongated beyond the proximal marker.There was no adverse patient effect or a clinically significant delay.No additional information was provided.
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The device was not returned for analysis.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 similar incidents from this lot.Images were reviewed and it was noted that when a balloon is inflated past nominal pressure, in this case to 16 atmospheres which is the rated burst pressure, the balloon can grow longitudinally and typically in the proximal region first which is by design.The investigation was unable to determine a conclusive cause for the reported device issue.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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