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

Model Number VT35005LA

Device Problem Partial Blockage (1065)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 01/30/2020

Event Type  Injury  

Event Description

The following was reported to gore: on (b)(6) 2020, the patient underwent a norwood procedure utilizing a gore-tex® vascular graft configured for pediatric shunt device.Physician confirmed all shunts are on prophylactic heparin until they¿re able to transition to aspirin and that aspirin responsiveness is checked in everyone prior to stopping heparin.On (b)(6) 2020, the shunt is found to be patent but mildly narrowed at its proximal anastomosis.A heparin drip is started on the patient.On (b)(6) 2020 a cardiac catheter with a stent is placed in the gore-tex® vascular graft configured for pediatric shunt.On (b)(6) 2020 an echo shows the pediatric shunt is patent but there is less flow through the shunt when compared to the previous echo which could indicate proximal or distal narrowing.On (b)(6) 2020, shunt ligation and takedown is performed and a "yellowish fluid" is found around the shunt.Samples from the yellowish fluid produced no growth on cultures.

Manufacturer Narrative

The investigation was completed and the following sections were updated accordingly: h6: investigation findings code: 213.H6: investigation conclusions code: 4315.

• 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
• MDR Report Key: 12015843
• MDR Text Key: 256700841
• Report Number: 2017233-2021-02090
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00733132616053
• UDI-Public: 00733132616053
• Combination Product (y/n): N
• PMA/PMN Number: K802095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/26/2021

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
• Device Expiration Date: 07/04/2023
• Device Model Number: VT35005LA
• Device Catalogue Number: VT35005LA
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/19/2021
• Initial Date FDA Received: 06/17/2021
• Supplement Dates Manufacturer Received: 05/19/2021
• Supplement Dates FDA Received: 08/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 6 DA
• Patient Weight: 3