It was reported that the procedure was to treat a mildly calcified, 85% stenosed lesion in the external iliac artery.A 7x39mm omnilink elite 35 vascular balloon-expandable stent system (bess) was advanced to the target lesion.An attempt was made to inflate the bess to deploy the stent however, the balloon only partially inflated, and the stent only partially expanded.Contrast was noted leaking into the artery through the tip of the balloon.This was repeated several times using different inflation devices and every time with the same results.It was decided to remove the bess, however the balloon was partially inflated, and the stent came off of the balloon.A new balloon was introduced through the badly damaged and deformed stent to be able to crush it against the wall and subsequently a new, 7x59mm omnilink stent was deployed successfully.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 similar incidents from this lot.A conclusive cause for the reported difficulties cannot be determined; however, the subsequent device embedded in tissue or plaque and unexpected medical intervention appear to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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