W. L. GORE & ASSOCIATES, INC. GORE-TEX® VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
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Device Problems
Device Alarm System (1012); Obstruction of Flow (2423)
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Patient Problems
Cardiogenic Shock (2262); Heart Failure/Congestive Heart Failure (4446); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 08/05/2021 |
Event Type
Injury
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Event Description
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The following publication was reviewed: "left ventricular assist device failure due to outflow graft compression by thrombofibrotic exudate." j thorac cardiovasc surg.2019 may ; 157(5): e259¿e261.Doi:10.1016/j.Jtcvs.2018.10.069.Author: gregory r.Jackson, md.We present 3 cases of lvad failure due to extrinsic outflow graft compression with thrombofibrotic exudate caused by use of an external outflow graft protective wrap gore-tex® vascular graft.A (b)(6)-year-old man with history of nonischemic cardiomyopathy on lvad support for 3.5 years (heartmate ii) presented with several months of progressive heart failure symptoms requiring repeat hospitalization for intravenous diuretics and temporary inotropic support.Several weeks after hospital discharge, he was readmitted with torsades de pointes requiring cardioversion, severe bi-ventricular failure, and cardiogenic shock requiring inotropic support and intravenous diuretics.He did not have any low-flow alarms preceding these events.Ccta demonstrated significant thrombotic material throughout the outflow graft, with marked narrowing of contrast flow in the more proximal aspect.The patient was taken to the operating room to unroof and relieve this obstruction.He recovered postoperatively with improvement in symptoms and decreased pharmacologic support.
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Manufacturer Narrative
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The gore tex vascular graft was not used as a vascular graft but used as a cover of the outflow graft of the left ventricular assist device (lvad).Blood flow went inside the outflow graft of the lvad from the pump body to the aorta, not inside the gore tex vascular graft.There is no suspected malfunction/deficiency of the gore tex vascular graft as it was not as used as intended and there is no identified harm to the patient by the gore tex vascular graft based on the information provided.As a result this medwatch will be retracted.
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