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

Model Number	VT35005LA
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	11/29/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported to gore: on (b)(6) 2018, a patient underwent a patent ductus arteriosus ligation as part of a blalock-taussig shunt procedure utilizing a gore-tex® vascular graft configured for pediatric shunt device.At an unknown date the patient presented with thrombosis in the gore-tex® vascular graft configured for pediatric shunt device.Further information has been requested but is not available at this time.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.
Event or Problem Description
The following was reported to gore: on (b)(6), 2018, a patient underwent a patent ductus arteriosus ligation as part of a blalock-taussig shunt procedure utilizing a gore-tex® vascular graft configured for pediatric shunt device.On (b)(6), 2018 at 0640, there was a patient decompensation event with oxygen desaturation, bradycardia, hypotension and cpr.A bedside echo demonstrated narrowing at the proximal anastomosis of the shunt due to a possible thrombus.The patient was taken to emergent or and a shunt revision was performed.On (b)(6), 2019 the shunt was removed with the creation of a bidirectional glenn.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.
Additional Manufacturer Narrative
Additional information was received and the following sections were updated accordingly: a4: patient weight added.B2: "other serious (important medical events)" added to adverse event outcomes.B5: description of event updated to include additional information received.H6: health effect - impact code: 4629.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: 12011371
• Report Number: 2017233-2021-02085
• Device Sequence Number: 3196894
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2021

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: 06/16/2021
• Supplement Report FDA Received Date: 07/21/2021
• 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; Other
• Patient Age: 21 DA
• Patient Weight: 7