Additional manufacturer narrative: examination of the returned device revealed the following: the entire device was returned; there was approximately 55 cm of deployment line between the hub and deployment knob; the endoprosthesis was partially expanded approximately 1.5 cm at the tip end of the endoprosthesis; there was delamination in the body of the endoprosthesis; the remainder of the endoprosthesis was still constrained; the distal shaft, upon which the endoprosthesis is mounted, appeared to be bowstrung; deployment was not able to be continued with traction on the deployment line at the endoprosthesis.Upon further inspection, there appeared to be a broken fiber near the location that deployment stopped.The remainder of the device was unremarkable.Based on the device examination performed, no manufacturing anomalies were identified to which the event could be definitively attributed.
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