GORE PROPATEN Vascular Graft HT067090ARecalls & reported problems
W. L. Gore & Associates, Inc. · PROPATEN VASCULAR GRAFT TW RR 6mmX90cm 70cm Rings Heparin · Class 2 · Implant
All models of GORE PROPATEN Vascular Graft (11)
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 00733132606665), received between May 14, 2020 and May 14, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (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
- Patient-Device Incompatibility1
Patient problems
- No Code Available1
- Thrombus1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 14, 2020Patient-Device Incompatibility; Patient-Device Incompatibility
IT WAS REPORTED TO GORE: A BYPASS WAS PERFORMED WITH A 6 MM GORE® PROPATEN® VASCULAR GRAFT IN THE MORNING, AND CLOTTED IN THE AFTERNOON. THE PHYSICIAN WENT IN FOR REVISION OF THE GRAFT AT THE TIBIAL ARTERY, THE DOCTOR MENTIONED THE ARTERY WAS SMALL BUT DID NOT INDICATE THE SIZE OF THE ARTERY DIAMETER. HE PLACED A STENT (UNKNOWN DEVICE) AT THE TIBIAL ARTERY. DOCTOR MENTIONED THAT ONLY A SMALL PORTION OF THE PROPATEN® VASCULAR GRAFT WAS EXPOSED TO THE BLOOD STREAM AT THE FEMORAL ARTERY DUE TO THE ADDITIONAL STENT PLACEMENT. THE PATIENT RECEIVED 6000 IU AT THE BEGINNING OF THE PROCEDURE, THEN 2000IU ABOUT 45 MINUTES LATER DURING THE PROCEDURE (IT WAS NOT CLEAR IF HE MEANT INITIAL PROCEDURE OR DE-CLOT/STENT PROCEDURE), DOCTOR STARTING SEEING CLOT AFTER 8000 IU OF SYSTEMIC HEPARIN HAD BEEN GIVEN. HE SAW CLOT IN THE FIELD AND THROMBUS IN THE GRAFT AGAIN, THROMBUS IN THE GRAFT WAS NOTED AS WHITE CLOT, WHICH COULD BE DOCTOR KNEW TO BE INDICATIVE OF HIT. HE BEGAN THE CESSATION OF SYSTEMIC HEPARIN AND PLACED PATIENT ON AGATROBAN®. HAS A HEMATOLOGIST ON THE CASE; SENT OUT A HIT PANEL, BUT DOES NOT HAVE RESULTS YET. PATIENT PLATELETS WERE INITIALLY 189,000, THREE DAYS LATER WERE MEASURED AT 13
Patient problems: No Code Available; Thrombus
MAUDE report 10059578 ↗
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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