GORE PROPATEN Vascular Graft Pediatric Shunt HPT040010ARecalls & reported problems
W. L. Gore & Associates, Inc. · PROPATEN VASC GRAFT TW PEDS 4mmX10cm Ped Shunt Heparin · 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 00733132606276), received between Jun 16, 2021 and Jun 16, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Complete Blockage” (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
- Complete Blockage1
Patient problems
- Bacterial Infection1
- 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 16, 2021Complete Blockage; Complete Blockage
THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2020, A PATIENT UNDERWENT A RIGHT THORACOTOMY AS PART OF A BLALOCK-TAUSSIG SHUNT PROCEDURE UTILIZING A GORE® PROPATEN® VASCULAR GRAFT CONFIGURED FOR PEDIATRIC SHUNT DEVICE. 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. ON THE SAME DAY AS THE INITIAL PROCEDURE, (B)(6) 2020, EVIDENCE OF DECREASING SATURATIONS AND ECHO STUDIES COULD NOT CONFIRM SHUNT PATENCY. A FEW HOURS AFTER, NO SHUNT FLOW COULD BE DETECTED. ON THE FOLLOWING DAY, (B)(6) 2020, THE SHUNT IS DIFFICULT TO SEE BY DOPPLER AND THERE DOESN'T APPEAR TO BE ANY FLOW THROUGH IT. A THROMBECTOMY WAS PERFORMED AND THE ORIGINAL SHUNT REMAINED. PROGRESSIVE NARROWING OF THE SHUNT WAS DESCRIBED WITH ECHO BEGINNING ON (B)(6), 2021. ON (B)(6) 2021 SHUNT LIGATION AND TAKEDOWN WAS PERFORMED AND PURULENT MATERIAL WAS FOUND AROUND THE SHUNT, WHICH WAS SUBTOTALLY THROMBOSED. PCR DETECTED STAPHYLOCOCCUS EPIDERMIDIS AROUND THE SHUNT.
Patient problems: Bacterial Infection; Obstruction/Occlusion; Thrombosis/Thrombus
MAUDE report 12011235 ↗
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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