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 other incidents from this lot.As there was no damage noted to the device during the inspection prior to use, it is possible that during deployment interaction with the anatomy and/or other devices resulted in the reported stent break; however, this could not be confirmed.The investigation determined a conclusive cause for the reported difficulties cannot be determined.The treatment appears to be related to the operational context of the procedure as a non-abbott stent was used and deployed intrastent the absolute stent.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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It was reported that the procedure was to treat a lesion in the portal trunk, in the context of an obstructive pancreas cancer.The absolute pro stent was fractured during stent release; there were several fractures in the stent, but no separation.The stent remained implanted, and a non-abbott stent was deployed inside the absolute pro stent.There was no adverse patient sequela and no clinically significant delay in procedure.No additional information was provided.
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