GORE-TEX Vascular Graft Pediatric Shunt VT05010LARecalls & reported problems
W. L. Gore & Associates, Inc. · VG T5MM X 10CM SILK · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132615896), received between Jun 17, 2021 and Jun 17, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Obstruction of Flow” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Obstruction of Flow1
- Partial Blockage1
Patient problems
- Obstruction/Occlusion1
- Thrombosis/Thrombus1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 17, 2021Partial Blockage; Obstruction of Flow; Partial Blockage; Obstruction of Flow
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 EXTRA
Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus
MAUDE report 12015819 ↗
Other PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER devices
- Cardioroot HEWROOT0030Intervascular Sas · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter1 recall2 deaths13 reports
- FLIXENE SLIDER GDS 25058Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall13 reports
- ADVANTA SLIDER GDS 22114Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall11 reports
- Cardioroot HEWROOT0032Intervascular Sas · Prosthesis, Vascular Graft, Of 6mm And Greater Diameter1 recall2 deaths10 reports
- FLIXENE SLIDER GDS 25129Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall9 reports
- ADVANTA SLIDER GDS 22222Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall8 reports
- FLIXENE SLIDER GDS 25137Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall8 reports
- FLIXENE SLIDER GDS 25138Atrium Medical Corporation · PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER1 recall7 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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