Device available for evaluation? yes, but actual device was discarded at user facility.Photo was received from user facility and evaluated by engineer.Engineering evaluation state, based on the available photograph, the following observations were made: there appears to be blood on the device, which is consistent with the reported event description.Several rows of the distal end of the stent were uncovered.The uncovered portion of the stent appeared expanded.The distal and proximal regions of the constraint sleeve appeared bunched.Based on the device photograph examination performed, no manufacturing anomalies were identified.Review of device manufacturing record history confirmed device met pre-release specifications.Device was not returned; therefore, direct product analysis was not possible.
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During treatment in the patient's superficial femoral artery (sfa) due to occlusive disease, a gore® tigris® vascular stent (stent) was advanced after the artery was predilated by a 3mm balloon.It was reported that during advancement, there was difficulty pushing the delivery catheter past the proximal sfa.The physician realized that about 2cm of the stent was unsheathed at the distal tip and the constraint sleeve appeared to be displaced.The delivery catheter was pulled back through the introducer sheath and removed from the patient.As reported, the constraint sleeve likely got stuck on vessel plaque as the device was pushed.The patient did not experience any adverse consequences.
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