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Specific shortcomings of endograft design
Tieying Yin1, Robert Guidoin, Marc M Corriveau
1Department of Surgery, Laval University and Quebec Biomaterials Institute, CHUQ, Quebec, Canada.
Journal of Long-Term Effects of Medical Implants
|December 17, 2009
Summary
A Vanguard modular stent graft failed due to suture breakage and Nitinol wire abrasion, leading to aneurysm rupture and patient death. Future devices require stronger sutures and improved fabric attachment to prevent such endovascular device failures.
Area of Science:
- Biomedical Engineering
- Vascular Surgery
Background:
- Endovascular aneurysm repair (EVAR) using stent grafts is a common treatment for abdominal aortic aneurysms.
- The Vanguard modular stent graft was used in a 79-year-old patient with a rapidly enlarging aneurysm.
Observation:
- The stent graft was monitored for 6 years post-implantation.
- Two years after the initial 6-year surveillance, the patient experienced an aneurysmal sac rupture.
- The patient died following open surgery after the rupture.
Findings:
- Post-mortem examination revealed device detachment and Nitinol wire abrasion.
- Broken polypropylene sutures and ruptured polyester yarns were identified as critical failures.
- Nitinol wire corrosion resistance was confirmed, but polypropylene suture material was deemed inappropriate.
- Abrasion from Nitinol wires created holes in the textile wall, allowing blood percolation.
Implications:
- The study highlights critical material and design weaknesses in early-generation endovascular devices.
- Recommendations include suturing Nitinol wires securely to the fabric and using stronger polyester yarns (e.g., >68 decitex).
- Addressing these issues is crucial for improving the safety and efficacy of future stent graft technologies.
