Visual and dimensional analysis was performed on the return device.The reported stent damage was confirmed.The failure to advance and difficulty removing could not be tested as it was based on the circumstances of the procedure.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 complaints from this lot based on the information provided, the reported difficulties appear to be due to case circumstances.The failure to advance was likely due to interaction with the anatomy.Additionally, during withdrawal, the proximal stent struts likely interacted with the distal end of the introducer sheath causing the struts to flare resulting in resistance with the sheath during removal.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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It was reported that the procedure was to treat a lesion in the left common iliac artery with no calcification or tortuosity noted.An 8x59mm omnilink elite balloon expandable stent (bes) was advanced to the aorta without issue, however, there was resistance with the anatomy advancing from the brachial to the common iliac, and the device did not reach the target lesion.The bes was removed with resistance noted, and it was noted that the stent struts were flared.There were no adverse patient effects and no clinically significant delay in the procedure.Another omnilink elite successfully completed the procedure.No additional information was provided.
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