It was reported that there was an issue with the absolute pro self expanding stent system (sess).The stent had to be removed via a cut down.Subsequent to the initially filed report, it was reported that the procedure was to treat the proximal superficial femoral artery (sfa).Halfway through deployment of the absolute pro stent, the thumbwheel got stuck and would not advance.The stent was stuck in the sheath which pulled it out from the delivery catheter.The patient was hospitalized additional time.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 resulting in the reported thumbwheel difficulties and the reported difficulty deploying the stent; however, this cannot be confirmed.The investigation was unable to determine a conclusive cause for the reported mechanical jam and the reported activation failure.During removal of the compromised device, interaction with the sheath resulted in the reported difficult to remove.The treatment appears to be related to the operational context of the procedure as reportedly the patient needed a cut down to remove the stent from the groin and the patient was hospitalized additional time.There is no indication of a product quality issue with respect to manufacture, design or labeling.E1: last name, title updated from unknown to dr.(b)(6).H6: medical device problem code 3190 removed and 1528, 3270, 2983 added.
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