MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE-TEX® VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT

Device Problems Off-Label Use (1494); Biocompatibility (2886)

Patient Problem Endocarditis (1834)

Event Date 09/27/2020

Event Type  Injury  

Event Description

This information was received through literature article ¿long-term results of large-calibre expanded polytetrafluoroethylene-valved conduits with bulging sinuses¿ published in the european journal of cardio-thoracic surgery, 27 september 2020.The purpose of this study was to clarify the long-term outcomes and the durability of eptfe-valved conduits.Between january 2002 and december 2015, there were 502 patients who underwent right ventricular outflow tract reconstruction in 34 japanese institutions using eptfe-valved conduits.The eptfe tricuspid-valved conduit is a handmade valved conduit manufactured through two major processes.First, bulging sinuses were molded on the eptfe graft (stretch vascular graft, w.L.Gore & associates, inc., flagstaff, az, usa) automatically using a custom-made machine.Second, the fan-shaped valves were cut from the 0.1-mm eptfe membrane (preclude pericardial membrane, w.L.Gore & associates, inc.) and sutured on the lumen side of the graft being turned inside out.The diameter of the conduit ranges from 18 to 24 mm, in 2-mm increments, corresponding to the size of the eptfe graft.The size of the conduit was selected depending on the physical constitution and the anatomical features of the heart.The article reports that two patients developed infective endocarditis of the conduit and received intravenous antibiotic therapy.

Manufacturer Narrative

Literature citation: fujita s, yamagishi m, miyazaki t, maeda y, itatani k, yamamoto y et al.Long-term results of large-calibre expanded polytetrafluoroethylenevalved conduits with bulging sinuses.Eur j cardiothorac surg 2020;58:1274¿80.Device information, patient information, and case details were requested from the corresponding author; however, to date, no additional information has been received.

• Brand Name: GORE-TEX® VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): KENDRICK PEAK MPD B/P; 4250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: marci stewart ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14776865
• MDR Text Key: 294544291
• Report Number: 2017233-2022-03035
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K802095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2022
• 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: 05/31/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 10 YR
• Patient Sex: Male
• Patient Weight: 28 KG