Complications and Lessons Learned From Global Use of the Streamliner Multilayer Flow Modulator (SMFM) Device

Abstract The flow modulator is a bare-metal graft for use in aortic, peripheral, visceral, and intracranial aneurysms. When the Streamliner Multilayer Flow Modulator (SMFM) technology was first introduced, there was no compulsion to inform and to train physicians in the new technology. Surgeons used this technology according to their judgment and discretion on a compassionate and trial-and-error basis. As with all new technologies in ill-informed hands, the consequences were catastrophic. Preoperative planning and deployment technique are key when using the SMFM. Normal proximal and distal landing zones as well as proper oversizing are crucial to provide sufficient radial force and prevent migration of the device. The SMFM should not be implanted in patients with aneurysm diameters >6.5 cm because of adventitial elastolysis, or in patients with evidence of infection resulting from a previous open repair graft or endograft. During deployment, the operator should deploy the SMFM at a slow rate of 1 cm per minute, known as “endoquilting,” allowing it to adhere to the vessel wall, preventing foreshortening and malexpansion or subsequent migration. Adequate overlap must be used when multiple SMFMs are implanted, to prevent dislocation, collapse, or endoleak. Stent occlusion can be avoided by placing the patient on clopidogrel postoperatively. Because SMFM technology is in its infancy, it is essential that a diligent preoperative plan be undertaken with a close follow-up strategy be undertaken. The SMFM is proving to be a promising option in endovascular surgery, mainly dissection, and this technological advancement can only improve in the future if research and development in device porosity and permeability and deployment technology are conducted. Positive outcomes follow, providing the limitations and instructions for use of the device are appreciated. Failing to avoid deviation from instructions for use will result in a catastrophic outcome.