It was reported optical coherence tomography was to be performed in the distal left anterior descending area, behind an implanted stent.When the dragonfly imaging catheter was pushed through the implanted distal stent, the dragonfly got stuck in the stent, was difficult to remove and caused a dissection.The dissection was treated with two stents.No additional information was provided.
|
The device was not returned for analysis.The lot history record could not be reviewed because the device was not returned, and the lot number was not provided.Additionally, a similar incident record review could not be performed because the device was not returned, and the lot number was not provided.Based on the information provided, the investigation was unable to determine a root cause for the reported failure to advance and difficult to remove.It may be possible that the anatomical conditions of the vessel and/or interaction with the implanted stent affected maneuverability of the device by preventing advancement.Furthermore, while advancing against resistance, the device or accessory device may have damaged and inadvertently caught on the implanted stent resulting in the reported difficult to remove and subsequent dissection.However, without having the device to examine, this could not be confirmed.Additionally, a cause for the reported patient effects of unexpected medical intervention and vascular dissection and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.H6: medical device problem code 4614 was removed and code 4641 was added.
|