In addition to the confirmed type 3a endoleak and the secondary endovascular procedure on (b)(6) 2017 (reference 2031527-2017-00693), clinical also found a complete component separation; cuff migration (1.5 cm); main body buckling; 3b of the cuff and superior stent cage dilation (28%).Cumulative knowledge informed by past assessments of similar complaints was applied to a review of the available medical information.The most likely cause of the compromised stent integrity of the cuff (breached), and the main body (superior stent margin) was the use of the strata material in combination with a progressive loss of overlap, likely cause by an extreme aortic and an iliac tortuosity.The complete component separation resulted in a loss of seal.The resultant component remodeling likely caused the stent migration and near complete buckling of the main body stent.Intra-operatively, the buckling precluded the physician from performing a successful reline and an additional surgical femoral to femoral bypass (and an aui procedure) was needed to repair the system.The patient was discharged home in stable condition.A review of the manufacturing lot confirmed all devices met specifications prior to release.The devices remain implanted in the patient and were not returned and no evaluation was completed.These types of events will be monitored and trended as part of the quality system.
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