Fabric defects causing type IIIb endoleaks (ELs) were first described > 20 years ago,
and this issue has recently been found at a high rate in the Medtronic (MDT; Santa
Rosa, CA) Valiant Navion (Navion) device.
1
,
2
,
3
Reporting device failures is important, and we applaud Weissler et al. for their attempt to bring further scrutiny to Navion device failures.
Update on Clinical Observations, Medtronic Valiant Navion Thoracic Stent Graft System, Global Voluntary Product Recall. May 31, 2022. Available at: https://www.medtronic.com/content/dam/medtronic-com/global/HCP/Documents/valiant-navion-urgent-medical-device-recall-update-May-2022-update.pdf. [Accessed March 1, 2023].
4
However, we are concerned that they have missed much of the important nuance required
in this type of study.To read this article in full you will need to make a payment
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References
- Identification and implications of transgraft microleaks after endovascular repair of aortic aneurysms.J Vasc Surg. 2001; 34: 190-197
- A preliminary analysis of late structural failures of the Navion stent graft in the treatment of descending thoracic aortic aneurysms.J Vasc Surg. 2021; 74: 1125-1134
Update on Clinical Observations, Medtronic Valiant Navion Thoracic Stent Graft System, Global Voluntary Product Recall. May 31, 2022. Available at: https://www.medtronic.com/content/dam/medtronic-com/global/HCP/Documents/valiant-navion-urgent-medical-device-recall-update-May-2022-update.pdf. [Accessed March 1, 2023].
- Association between device type and type IIIb endoleaks following thoracic endovascular aortic repair.Eur J Vasc Endovasc Surg. 2023; 65: 112-119
- A systematic review of the quality of cardiovascular surgery studies that extracted data from the MAUDE database.J Vasc Surg. 2021; 74: 1708-1720
Article info
Publication history
Published online: February 14, 2023
Accepted:
January 26,
2023
Received:
January 16,
2023
Publication stage
In Press Corrected ProofIdentification
Copyright
© 2023 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.
ScienceDirect
Access this article on ScienceDirectLinked Article
- Association Between Device Type and Type IIIb Endoleaks Following Thoracic Endovascular Aortic RepairEuropean Journal of Vascular and Endovascular SurgeryVol. 65Issue 1
- PreviewEndoleaks following thoracic endovascular aortic repair (TEVAR) can lead to the need for re-intervention and aortic rupture. Given the recent recall of a specific thoracic stent graft type due to concerns about type IIIb endoleak (T3bE), in which blood leaks through the stent graft fabric, the aim was to characterise patterns of T3bEs among available TEVAR devices.
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- Failing To See the Forest for the TreesEuropean Journal of Vascular and Endovascular Surgery
- PreviewWe appreciate the attention Ouriel et al. have dedicated to reviewing our work.1 However, their complete dismissal of our findings raises significant concerns for conscious or unconscious bias on their part, given their extensive industry ties,2 and furthermore runs counter to ongoing efforts to improve medical device safety. Specifically, we would like to address the following points.
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