It was reported that the procedure was to treat the external iliac vein with no calcification and no tortuosity.During the procedure, the thumbwheel of the 10x80 mm absolute pro self expanding stent system (sess) would not roll back; however, the stent was deployed but it was mangled.The stent remains fully inside the target lesion.There was additional balloon dilatation to fully expand the stent.There were no adverse patient sequela and there was no clinically significant delay in the procedure.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 other incidents from this lot.As there was no damage noted to the device during the inspection prior to use, it is possible that the device was bent in the anatomy resulting in preventing the shaft lumens from moving freely; thus resulting in the reported thumbwheel difficulties and the reported difficulty deploying the stent; however this cannot be confirmed.The investigation determined a conclusive cause for the reported difficult or delayed activation and the reported mechanical jam cannot be determined.Manipulation in attempts to deploy the stent likely resulted in the reported material deformation (stent partially mangled).The treatment appears to be related to the operational context of the procedure as additional balloon dilatation was performed to fully expand the stent.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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