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

Model Number VT05010LA

Device Problems Partial Blockage (1065); Obstruction of Flow (2423)

Patient Problems Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)

Event Date 03/17/2021

Event Type  Injury  

Event Description

The following was reported to gore: on (b)(6) 2021, the patient underwent a procedure to repair an artery in the torso as part of a blalock-taussig shunt upsizing 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 Description

The following was reported to gore: on march 17, 2021, the patient underwent a procedure to repair an artery in the torso as part of a blalock-taussig shunt (btt shunt) upsizing procedure (original shunt placed on (b)(6) 2020) utilizing a gore-tex® vascular graft configured for pediatric shunt device.A therapeutic heparin drip was utilized post-operation.On (b)(6) 2021, cta for shunt evaluation was performed due to high oxygen requirements and marginal saturations.Shunt was patent without associated narrowing.The patient continued to have episodes of significant desaturations post-operatively.On (b)(6) 2021, an echocardiogram demonstrated proximal btt shunt continuous flow, but it was difficult to trace the more distal shunt to the pulmonary arteries.On (b)(6) 2021 the patient underwent a cardiac catheterization with stent placement in the shunt after finding severe narrowing of distal btt shunt measuring approximately 2.5mm.There was significant improvement of systemic arterial oxygen saturation after stent placement.On (b)(6) 2021 the patient was discharged home on lovenox and aspirin.On (b)(6) 2021, the patient was returned to the hospital with cpr in progress and extracorporeal membrane oxygenation (ecmo) was initiated.On echocardiogram demonstrated that the stent was in place with apparent left-to-right shunting.On (b)(6) 2021, cta showed no convincing evidence of shunt thrombosis.Patient death was recorded on (b)(6) 2021 with the gore-tex® vascular graft configured for pediatric shunt device still implanted.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.

Manufacturer Narrative

Additional information was received and the following sections were updated accordingly: h6: health effect - clinical code: 2422, h6: health effect - impact code: 4642, h6: medical device problem code: 1065, 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: 12015819
• MDR Text Key: 256702436
• Report Number: 2017233-2021-02089
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00733132615896
• UDI-Public: 00733132615896
• 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: 08/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: VT05010LA
• Device Catalogue Number: VT05010LA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 15 MO
• Patient Weight: 10