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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 12/17/2019

Event Type  Injury  

Manufacturer Narrative

Patient demographics: provided mean age was 53 years old and gender of article is 72.2% male, 27.8% female.Patient information will reflect (b)(6) male.Patient weight and implant date are not available.

Event Description

The following information was received through literature ¿hemashield vascular graft is a preferable prosthetic graft for middle hepatic vein reconstruction in living donor liver transplantation¿ published in annals of transplantation.This study describes postoperative complications in patients who had ringed gore tex vascular grafts (vg) (n=126) implanted as part of middle hepatic vein reconstruction from january 2011 to december 2013.All 126 patients were alive until the end of august 2019 and were subjected to regular follow-up at the outpatient clinic.Ct scans showed that luminal thrombosis occurred within the vg around the v5 anastomosis.The lumen of a graft conduit between v5 and v8 orifices was occluded.4 patients required mhv stenting within 3 weeks of lt.

Manufacturer Narrative

Article citation: hemashield vascular graft is a preferable prosthetic graft for middle hepatic vein reconstruction in living donor liver transplantation park gil-chun, shin hwang, et al.Doi: 10.12659/aot.919780 annals of transplantation 2019; 24: 639-646.

• 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
• MDR Report Key: 12056304
• MDR Text Key: 264310228
• Report Number: 2017233-2021-02116
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• PMA/PMN Number: K802095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 07/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/25/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR