GORE PROPATEN Vascular Graft HT083040ARecalls & reported problems
W. L. Gore & Associates, Inc. · PROPATEN VASCULAR GRAFT TW RR 8mmX40cm 30cm 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
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132606801), received between Aug 29, 2018 and Aug 29, 2018 — classified as 1 death.
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
- Death1
- Occlusion1
- Stroke/CVA1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathAug 29, 2018Complete Blockage; Complete Blockage
THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2018, A PATIENT WITH A HISTORY OF CABG X 4, CARDIAC STENTS X 3 PRESENTED WITH ACUTE ONSET OF CHEST PAIN, SHORTNESS OF BREATH AND GENERALIZED WEAKNESS. PATIENT WAS GIVEN NITROGLYCERIN AND SHE BECAME UNRESPONSIVE WITH SEIZURE-LIKE ACTIVITY. DUE TO THE NATURE OF ACUTE TYPE, A DISSECTION AND RISK OF RUPTURE, IT WAS DECIDED TO NOT PURSUE EMERGENT OPEN REPAIR GIVEN HIGH RISKS OF PROCEDURE. PATIENT WAS ADMITTED FOR AGGRESSIVE BLOOD PRESSURE AND PAIN MANAGEMENT. OVER THE NEXT FEW DAYS, THE VASCULAR SURGERY TEAM DECIDED TO REPAIR VIA ENDOVASCULAR APPROACH. ON (B)(6) 2018, THE PATIENT REQUIRED 2U PRBCS FOR ANEMIA WITH CONCERN FOR RUPTURE DUE TO HEMATEMESIS AND MELENA. PATIENT UNDERWENT DEBRANCHING WITH PATENT RIGHT COMMON CAROTID TO LEFT SUBCLAVIAN ARTERY GRAFT WITH THE LEFT COMMON CAROTID JUMP GRAFT CONNECTION TO THIS GRAFT. AS REPORTED, AN 8MM GORE® PROPATEN® VASCULAR GRAFT (THIN WALLED REMOVABLE RINGED) WAS IMPLANTED DURING THIS PROCEDURE. IN ADDITION, THORACIC AORTIC REPAIR, STENT GRAFT PLACEMENT IN THE INNOMINATE ARTERY AND IMPLANTATION OF A TEMPORARY TRANSVENOUS PACEMAKER WERE PERFORMED. EGD (ESOPHAGOGASTRODUODENOSCOPY) WAS COMPLETED POST-O
Patient problems: Death; Occlusion; Stroke/CVA
MAUDE report 7831061 ↗
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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