No part of the device was returned for evaluation.No images were available for evaluation.The medical director reviewed the information supplied in the complaint as no imaging was received and confirmed the separation between the zfen-p and zfen-d causing thrombosis.He stated "this is a typical graft separation, whereby the zfen-d has 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 is still in good position, held in place by the fixation stent proximally, and the two renal bridging stents in the renal fenestrations.The problem is that the increased curvature of the device has 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." work order review could not be completed as the lot number is unknown.The instructions for use (ifu) supplied with the complaint device states: the long-term performance of fenestrated endovascular grafts, including the stents placed in fenestrations/scallops, has not yet been established, and all patients should be advised that endovascular treatment requires life-long, regular follow-up to assess their health and the performance of their endovascular graft.Potential adverse events that may occur and/or require intervention include, but are not limited to: endoleak, component migration.Based on the information provided, the root cause could not be determined.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.A corrective and preventative action [capa] was raised to address concerns of separation for the zfen-us devices.The corrective and preventative action [capa] determined "the conclusion of the investigation was that there is no fault/non-conformance of the us fen device, its labelling, its instruction for use [ifu], its manufacturing, nor its clinical use.The zfen us configuration meets the acceptance criteria for this product and the acceptance criteria are deemed acceptable.".
|