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

Model Number	VT04010LA
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	01/03/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported to gore: on (b)(6) 2020, the patient underwent a right thoracotomy 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) 2020, the patient underwent a right thoracotomy as part of a blalock-taussig shunt procedure utilizing a gore-tex® vascular graft configured for pediatric shunt device.On (b)(6) 2020, a shunt murmur could not be identified and an echocardiogram and cta scan confirmed shunt thrombosis.The patient was given heparin and tpa infusions.On (b)(6) 2020 an echocardiogram revealed that the shunt was open.Another echocardiogram on (b)(6) 2020 confirmed that the shunt remained open.On (b)(6) 2020 the patient was discharged home on lovenox.On (b)(6) 2020 a tetralogy of fallot repair was performed at which time the shunt was removed.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.B5: description of event updated to include additional information received.H6: health effect - impact code: 4644.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: 12015795
• Report Number: 2017233-2021-02087
• Device Sequence Number: 11921443
• Product Code: DSY
• UDI-Device Identifier: 00733132615865
• UDI-Public: 00733132615865
• 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): 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: 10/17/2023
• Device Model Number: VT04010LA
• Device Catalogue Number: VT04010LA
• 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: 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
• Patient Age: 11 DA
• Patient Weight: 7