Conformable GORE® TAG® Thoracic Endoprosthesis 에 대한 현장 안전성 서한

Field Safety Notice

2017-10-23

Slovenia

AMPMDRS

• since december 2016, gore has received four similar reports of incomplete and / or partial deployments of the conformable tag® device. in each event, the physician observed that half of the conformable tag® device deployed and half remained constrained to the delivery catheter. each of these events occurred during an off-label procedure, but it is unclear at this time how this may have affected the outcomes. engineering evaluations for two returned devices indicate that one partial deployment was the result of an incorrect deployment line stitch pattern and another was the result of deployment line damage of unknown origin. the other two devices have not been returned to gore for evaluation. • there were two serious adverse health consequences and one death reported: – one patient required intra-operative surgical conversion and subsequently died. – one patient required intra-operative surgical conversion and experienced temporary mesenteric and renal ischemia. – one patient required an additional surgical intervention and experienced temporary renal ischemia. – one patient sustained no injuries due to deployment during an open repair. • while incomplete deployments are known adverse events and identified within the instructions for use (ifu), gore has seen an increased frequency of these partial deployment events in conformable tag® devices sold (totaling 0.03% of 12,865 devices distributed*) that were manufactured in the prior year compared to those manufactured earlier. .