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

Device Problem Partial Blockage (1065)

Patient Problem Occlusion (1984)

Event Date 08/11/2020

Event Type  Injury  

Event Description

1-month dapt evidence in complex patients - use of the gore viabahn vbx balloon-expandable endoprosthesis in the congenital heart disease population¿; jason cole m.D.; arash salavitabar, m.D.; aimee armstrong m.D.; darren berman m.D.; pediatric cardiology, nationwide children's hospital, columbus, ohio; received: 1 march 2019; revised: 17 may 2019; accepted: 22 june 2019; wileyonlinelibrary.Com/journal/ccd; catheter cardiovasc interv.2019;94:416¿421."the article presents three patients with underlying congenital heart disease (chd) ranging in age from 1 day to 30 years in whom the vbx covered stent was used." case 2 - a (b)(6) year-old male with a posterior-malaligned ventricular septal defect (vsd) and type b interrupted aortic arch with aberrant right subclavian artery (rsca) was initially repaired in infancy with a vsd patch and a 10 mm gore-tex interposition gore-tex® vascular grafts.He was lost to follow-up for 10 years and presented with chest pain, lower extremity claudication, and severe upper extremity hypertension.A 7 mm × 19 mm gore viabahn vbx covered stent was chosen for the interposition graft due to its radial strength, as well as to utilize its graft material to protect against potential aortic wall injury upon relief of the severe stenosis.It was advanced to the proximal portion of the stenosed interposition graft.Case 3 - a (b)(6) year-old female with heterotaxy syndrome, polysplenia, unbalanced right ventricular (rv) dominant avc, double outlet rv, pulmonary stenosis, with bilateral svc and interrupted inferior vena cava to the lsvc was status post left kawashima and right bidirectional glenn anastomoses, followed by an extracardiac fontan conduit.A 13 mm × 50 mm gore viabahn self-expanding endoprosthesis was chosen to seal the ostium of the aneurysm and fistula, as there was no stenosis in the axillary artery that would require the radial strength of the balloon expandable gore viabahn vbx stent.

Manufacturer Narrative

Patient and event information were requested, but author declined to provide any details.As a result, further investigation was not possible.

• 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: 11158590
• MDR Text Key: 229570027
• Report Number: 2017233-2021-01596
• 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: literature
• Type of Report: Initial,Followup
• Report Date: 08/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• 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: 08/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention