News | Stent Grafts | October 09, 2017

FDA Concerned About Increase in Endovascular Type III Leaks

Agency will continue working with endovascular graft manufacturers to understand reasons behind increase

FDA Concerned About Increase in stent graft Endovascular Type III Leaks

October 9, 2017 — The U.S. Food and Drug Administration (FDA) is evaluating recent information regarding Type IIIa and IIIb endoleaks with the use of endovascular graft systems indicated for a procedure known as endovascular aneurysm repair (EVAR). EVAR treats abdominal aortic aneurysms (AAA) and aorto-iliac-aneurysms.

Recent information from several sources, including FDA's Medical Device Reporting (MDR) system and Annual Clinical Updates to Physicians by the manufacturers, suggests an increase in the occurrence of Type III endoleaks. This increase is compared to earlier clinical update reports in patients with various device models and implant duration lengths, including some patients who had previously stable repairs. 

FDA is bringing this potential complication to the public’s attention to remind and encourage them to report Type IIIa and IIIb endoleak events to the manufacturer and the FDA. This may include reporting individual events as well as rates they may have experienced in their practice.

The FDA continues to work with all manufacturers of endovascular graft systems to better understand this issue, including the prevalence of Type III endoleaks, contributing factors, and the risks and benefits of secondary interventions to address these endoleaks. The FDA will keep the public informed as significant new information becomes available.

EVAR is intended to exclude the AAA sac from the arterial circulation and prevent AAA rupture, which is a life-threatening event. In the presence of a Type III endoleak, AAA is not excluded from flow and systemic arterial pressurization of the aneurysm sac, resulting in an increased risk of rupture.

The FDA considers a Type III endoleak a device-related event that requires treatment with additional interventions such as re-lining, insertion of additional endograft components or open surgical repair. The secondary interventions to address endoleaks carry added risks for impacted patients. Predictors of Type III endoleak may include treatment with early generation graft materials, the presence of calcified plaque, and inadequate overlap between components.

The FDA recommends that healthcare providers:

  • Continue lifelong surveillance of patients who have been treated with endovascular grafts;
  • Consider Type III endoleaks in the differential diagnosis of patients presenting with symptoms of potential aneurysm expansion or rupture;
  • Discuss with your patients all available treatment options to address Type III endoleaks, including the risks and benefits of each, before deciding the best treatment approach;
  • Report any of the following to MedWatch, the FDA Safety Information and Adverse Event Reporting Program Online Voluntary Reporting Form:
    • early or late device-related adverse events – including Type IIIa and IIIb endoleaks – associated with the use of endovascular graft systems in EVAR;
    • device-related adverse events that occur as a result of a secondary intervention to treat Type III endoleaks; and
  • Device manufacturers and user facilities must comply with the applicable Medical Device Reporting (MDR) regulations. Healthcare personnel employed by facilities that are subject to FDA's user facility reporting requirements should follow the reporting procedures established by their facilities. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online:
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch Safety Alert, including a link to the FDA Letter to Health Care Providers.

For more information:

Related Content

Endologix Receives IDE Approval for EVAS2 Confirmatory Clinical Study
News | Endovascular Aortic Repair| October 19, 2017
Endologix Inc. received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA...
Peter Schneider, M.D. presents late breaking clinical trial results at VIVA 17 in Las Vegas. Panelists (l to r) Krishna Rocha-Singh, M.D., Sean Lyden, M.D., John Kaufman, M.D., Donna Buckley, M.D.

Peter Schneider, M.D. presents late breaking clinical trial results at VIVA 17 in Las Vegas. Panelists (l to r) Krishna Rocha-Singh, M.D., Sean Lyden, M.D., John Kaufman, M.D., Donna Buckley, M.D.

Feature | Cath Lab| September 14, 2017
September 14, 2017 — Here are quick summaries for all the key late-breaking vascular and endovascular clinical trials
Gore Announces First-in-Human Use of Gore TAG Conformable Thoracic Stent Graft
News | Stent Grafts| July 17, 2017
W. L. Gore & Associates Inc. announced the first patient implant of the Gore TAG Conformable Thoracic Stent Graft...
New Paper Highlights Success of Advanced Treatments in Complex Aortic Aneurysm Repair
News | Endovascular Aortic Repair| May 23, 2017
Significant success has been achieved in treating complex proximal aneurysms using a combination of fenestrated and...
News | Stent Grafts| April 06, 2017
Endologix Inc. announced that the first patients were treated in the Expanding Patient Applicability with Polymer...
abdominal aortic aneurysm, AAA, gender differences, women vs. men, endovascular repair, Journal of Vascular Surgery study
News | Endovascular Aortic Repair| April 05, 2017
Following repair of abdominal aortic aneurysms (AAA), women appear to have more unfavorable outcomes than men in terms...
Gore, Viabahn VBX Balloon Expandable Endoprosthesis, stent graft, iliac artery, FDA approval
Technology | Stent Grafts| January 31, 2017
W. L. Gore & Associates (Gore) announced that the Gore Viabahn VBX Balloon Expandable Endoprosthesis (VBX Stent...
Lombard Medical, Aorfix endovascular stent graft, Japanese regulatory approval, IntellFlex LP Delivery System
News | Stent Grafts| January 11, 2017
January 11, 2017 — Lombard Medical Inc.
stent grafts, fluid flow model, clotting risk, Journal of Vascular Surgery

An anterior view is shown of the geometries of each of the graft configurations: (A) fenestrated, (B) antegrade branched, (C) retrograde branched, and (D) manifold stent graft. Image courtesy of Taylor Suess, et al.

News | Stent Grafts| January 05, 2017
January 5, 2017 — Whether patients with mechanical heart valves and stents must take blood thinners depends on how ef
Videos | Artificial Intelligence| December 19, 2016
At RSNA 2016, the key buzzwords were “deep learning,” “machine learning” and “artificial intelligence.” Vendors and m
Overlay Init