No product was available for evaluation.Review of the imaging taken from a ct scan in 2019 showed the graft in good position, with a full two-stent overlap between the zfen-p and the zfen-d.Review of the ct scan taken after the patient presented to hospital in (b)(6) 2021 showed graft separation, whereby the zfen-d had pulled out of the zfen-p, following the increased ¿bowing¿ of the graft forward as it moved through the aneurysm and came to lie up against the anterior wall.The zfen-p was noted to still be in good position, held in place by the fixation stent proximally and the two renal bridging stents in the renal fenestrations.The medical director who reviewed the imaging, determined that the increased curvature of the device had caused the zfen-d to pull out of the zfen-p, leading to separation and a full type 3 endoleak, causing re-pressurization of the aneurysm.The relevant work orders were reviewed and appeared complete and correct.A review of review of ifu ¿zenith® fenestrated aaa endovascular graft ifu-fu/3¿ supplied with the device was found to provide sufficient information for patient selection, the deployment of fenestrated grafts, and warning and precautions including the need for patients to be regularly monitored for perigraft flow, aneurysm growth, patency of vessels accommodated by a fenestration/scallop, or changes in the structure or position of the endovascular graft.Based on the information provided, and review of the supplied imaging, a definitive root cause was unable to be determined.The zfen-p device was noted to still be in good position, held in place by the fixation stent proximally and the two renal bridging stents in the renal fenestrations it is possible that the separation was due to: inadequate diameter tolerance to ensure interference at overlap.Inadequate separation force.Inadequate length of overlap.Patient-related factors.
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