GORE PROPATEN Vascular Graft Pediatric Shunt HPT350010ARecalls & reported problems
W. L. Gore & Associates, Inc. · PROPATEN VASC GRAFT TW PEDS 3.5mmX10cm Ped Shunt Heparin · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00733132606412), received between Mar 16, 2021 and Jun 17, 2021 — classified as 2 injuries.
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
- Thrombosis/Thrombus2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 17, 2021Obstruction of Flow; Obstruction of Flow
THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6), 2021, THE PATIENT UNDERWENT A BLALOCK-TAUSSIG SHUNT PROCEDURE UTILIZING A GORE® PROPATEN® VASCULAR GRAFT CONFIGURED FOR PEDIATRIC SHUNT DEVICE. WITHIN 30 MINUTES OF COMPLETION OF THE PROCEDURE, THE PATIENT EXPERIENCED OXYGEN DESATURATIONS AND HYPOTENSION. THE PATIENT RECEIVED FLUID RESUSCITATION. THE SHUNT MURMUR WAS RECORDED AS NOTABLY "ALTERED". AN ECHOCARDIOGRAM SHOWED NO DEFINITE FLOW VISUALIZED THROUGH THE BLALOCK-TAUSSIG SHUNT. THE PATIENT RECEIVED HEPARIN BOLUS AND TPA INFUSION. THE PATIENT INITIALLY IMPROVED, BUT DESATURATIONS CONTINUED AND THE PATIENT WAS RETURNED TO THE OPERATING ROOM FOR A THROMBECTOMY OF THE BLALOCK-TAUSSIG SHUNT. AS OF (B)(6), 2021, THE SHUNT REMAINS 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.
Patient problems: Thrombosis/Thrombus
MAUDE report 12015811 ↗InjuryMar 16, 2021Partial Blockage; Partial Blockage
THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2021, A GORE® PROPATEN® VASCULAR GRAFT CONFIGURED FOR PEDIATRIC SHUNT WAS PLACED FOR TREATMENT OF SEVERE PULMONARY STENOSIS IN A PATIENT WITH TETRALOGY OF FALLOT (TOF). AT 1651 ON (B)(6) 2021, THE PATIENT CAME OUT OF THE OPERATING ROOM TO THE INTENSIVE CARE UNIT UNEVENTFULLY, AT 1830 AN EMERGENCY REDO STERNOTOMY EMERGENCY CARDIAC RESUSCITATION ON CARDIOPULMONARY BYPASS IN THE UNIT WAS PERFORMED, USING A 3FR FOGARTY ARTERIAL EMBOLECTOMY CATHETER TO DECLOT GRAFT AND FLUSHED WITH A HEPARINIZED SOLUTION. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES. THE PHYSICIAN STATED: THE THROMBOSIS POSSIBILITY FORMED DUE TO THE HYPERCOAGULABLE STATE OF THE BABY AND SMALL SIZE OF THE BRANCH PULMONARY ARTERY STENOSIS. ON (B)(6) 2021 PATIENT EXTUBATED AND PLACED ON CONTINUOUS POSITIVE AIRWAY PRESSURE THERAPY.
Patient problems: Thrombosis/Thrombus
MAUDE report 11496114 ↗
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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