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

Model Number	VT35005LA
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	01/30/2020
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 12015843
• Report Number: 2017233-2021-02090
• Device Sequence Number: 17302425
• Product Code: DSY
• UDI-Device Identifier: 00733132616053
• UDI-Public: 00733132616053
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K802095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 07/04/2023
• Device Model Number: VT35005LA
• Device Catalogue Number: VT35005LA
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/19/2021
• Supplement Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 06/17/2021
• Supplement Report FDA Received Date: 08/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 6 DA
• Patient Weight: 3