It was reported to gore that a 8mm x 5cm gore® viabahn® endoprosthesis was to be implanted for treatment of the right common iliac artery aneurysm.When the device was advanced to the target lesion, the physician initiated the deployment line.When the device was deployed around 1-2cm, the deployment line got stuck and could not be deployed further.Then the physician retracted the device out of the patient together with the delivery system and the physician used the bard fluency graft to complete the procedure.The patient did not experience any adverse consequences.
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An engineering evaluation was performed on the returned device.The evaluation results stated that the entire device was returned.There was approximately 18 cm of deployment line between the hub and deployment knob.There was a kink in the distal shaft, upon which the endoprosthesis is mounted, at the transition.The distal shaft was exposed approximately 0.5 cm at the transition.The endoprosthesis was longitudinally compressed towards the tip end of the device.The endoprosthesis was partially expanded approximately 1.5 cm at the tip end of the endoprosthesis.The remainder of endoprosthesis was still constrained.Deployment was able to be continued with traction on the deployment line at the endoprosthesis.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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