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Published on: June 14, 2011
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Nellix Device Failure Mechanisms Analysis on Explanted Grafts
Léna Christ1, Salomé Kuntz1,2, Damir Vakhitov1,3
1GEPROMED, Strasbourg, France.
Summary
Degradation of the polymer in Nellix endovascular aneurysm sealing devices can cause device failure, leading to endoleaks and migration. Patients require lifelong surveillance due to unpredictable device performance.
Area of Science:
- Biomaterials Science
- Medical Device Engineering
- Vascular Surgery
Background:
- The Nellix device, used for endovascular aneurysm sealing (EVAS), has shown poor durability.
- Understanding the material degradation of EVAS devices is crucial for patient safety.
Purpose of the Study:
- To investigate the reasons for the poor durability of the Nellix EVAS device.
- To examine the structural integrity of the device's polymer endobags and metal stents.
Main Methods:
- Analysis of 21 explanted Nellix endoprostheses.
- Visual examination of stent structures and instrumental examination of polymer endobags.
- In vitro testing of polymer samples under simulated implantation conditions (wet and dry exposure).
Main Results:
- Iatrogenic defects were found in 76% of metal stents and 95% of endobags.
- Polymer disintegration due to degradation occurred in 71% of cases.
- Degraded polymer lost significant weight and volume upon dehydration, with partial recovery in saline.
Conclusions:
- Polymer degradation, evidenced by weight and volume loss during dehydration, is a likely cause of Nellix device failure.
- This degradation can lead to endoleaks and device migration.
- Patients with Nellix endografts require enhanced, lifelong surveillance due to unpredictable performance and potential for device failure.
