W.L. Gore & Associates issued an urgent field safety notice in Europe to warn on issues with its Excluder AAA Endoprosthesis and Excluder Iliac Branch.
Both Excluder products may experience the separation of the leading end of catheter components, according to the safety notice out of Germany. From January 2013 to Aug. 5, 2019, Gore received 346 reports of leading end catheter component separations with the Excluder devices.
Of the 346 events, 30 reported immediate health consequences and one long-term health consequence, which turned out to be pelvic ischemia. Following an internal investigation, Gore uncovered two forms of failure modes: the unbonded leading end catheter components (olives) and breakage (separation) of leading end catheter components. The company noted that the failure modes have not resulted in the fragmentation of the separated component.
The majority of the 30 health consequences reported occurred with failure modes other than the confirmed unbonded leading end catheter component and devices utilized in challenging anatomies and/or with user actions that are warned against.
Gore listed potential device and/or procedure-related adverse events or patient risks related to the Excluder issue as additional intraoperative procedure time, additional intraoperative and/or secondary surgical or endovascular procedures, iliac artery occlusion, iliac dissection, iliac rupture, leading end catheter component retention, pelvic ischemic events, surgical bypass, surgical cut-downs, surgical conversion, unintentional/premature endoprosthesis deployment and wound infection at the cut-down site.
The company said it has not received reports of long-term health consequences related to the patients with retained components, but, based on physician input, physicians should consider an additional follow-up as needed in such patients.
Gore added that it is confident in the safety and efficacy of the Excluder devices if they are used in accordance with the instructions. Thus, the company does not plan to remove the devices from the market, due to its determination that the patient benefits are greater than the potential risks.
However, the company does plan to update its instructions for use with a new warning of catheter leading end separation, along with other warnings to emphasize the risks of catheter breakage and premature deployment
Gore touts its Excluder Iliac Branch, which is used in conjunction with the Excluder AAA Endoprosthesis, as the only off-the-shelf, FDA-approved aortic branch device for the endovascular treatment of common iliac artery aneurysms or aortoiliac aneurysms. The Excluder AAA Endoprosthesis won CE Mark approval in Europe in June 2016.
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