MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE-TEX® VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Device Problems Device Alarm System (1012); Obstruction of Flow (2423)

Patient Problems Cardiogenic Shock (2262); Heart Failure/Congestive Heart Failure (4446); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/05/2021

Event Type  Injury  

Event Description

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.

Manufacturer Narrative

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.

• Brand Name: GORE-TEX® VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL WEST B/P; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer Contact: marcos ayala ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12410965
• MDR Text Key: 269504470
• Report Number: 2017233-2021-02326
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K802095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 29 YR
• Patient Sex: Male