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# FDA Panel To Review Cordis PMA Adverse Events
- URL: https://www.fdaweb.com/fda-panel-to-review-cordis-pma-adverse-events/
- Published: 2018-05-11T12:00:00.000Z
- Updated: 2026-09-15T00:04:40.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5141413

*Federal Register* notice: FDA’s Circulatory System Devices Panel of the Medical Devices Advisory Committee is scheduled to meet 6/12 to review a Cordis PMA for the Incraft AAA Stent Graft System, which is intended for the endovascular treatment of infra-renal abdominal aortic aneurysms in patients with appropriate anatomy. The device is being evaluated in the INSPIRATION study, and results showed higher than anticipated rates of certain adverse events. The committee discussion will focus on how these events impact the device’s long-term safety and effectiveness, as well as its benefit/risk profile. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-05-11/pdf/2018-10050.pdf?ref=fdaweb.com).