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

Device Problems Obstruction of Flow (2423); Infusion or Flow Problem (2964)

Patient Problem 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.A (b)(6) year-old man with nonischemic cardiomyopathy on 4.5 years of support (heartware assist device; medtronic, minneapolis, minn) presented with progressive heart failure symptoms and accompanied low-flow alarms and increased power irregularities on device interrogation.Transthoracic echocardiogram demonstrated severely dilated left ventricle (left ventricular internal diastolic diameter, 9.2 cm) at speed of 3200 rpm, with preserved aortic valve excursion.Ccta revealed severe narrowing and obstruction of the outflow graft suggestive of external compression.The patient underwent surgical intervention with removal of the anterior portion of the gore-tex® vascular graft and evacuation of exudate from around the outflow graft, resulting in immediate resolution of low flow.

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 ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: marcos ayala ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12410575
• MDR Text Key: 274098078
• Report Number: 2017233-2021-02325
• 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
• 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

• 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
• Initial Date Manufacturer Received: 08/05/2021
• Initial Date FDA Received: 09/01/2021
• Supplement Dates Manufacturer Received: 08/05/2021
• Supplement Dates FDA Received: 03/17/2022
• 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: 46 YR
• Patient Sex: Male