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 Erosion (1750)

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 info is not available.Implant date and explant 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 (b)(6) 2011 to (b)(6) 2013.All 126 patients were alive until the end of (b)(6) 2019 and were subjected to regular follow-up at the outpatient clinic.Accidental migration of the vg into the gastric wall occurred in 2 cases, at 6 months and 3 years after liver transplantation.They underwent exploratory laparotomy to remove vg.Author believed that the primary mechanism underlying accidental migration of vg is based on foreign body-induced inflammatory reactions.

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 submit a follow-up fda report to add pma/510(k)number to g3/4; add citation to h10/11.

• 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: 12056284
• MDR Text Key: 258041243
• Report Number: 2017233-2021-02115
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/25/2021
• Initial Date FDA Received: 06/24/2021
• Supplement Dates Manufacturer Received: 05/25/2021
• Supplement Dates FDA Received: 07/12/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR