GORE PROPATEN Vascular Graft HT087080ARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00733132606849), received between Aug 15, 2018 and Feb 12, 2021 — classified as 2 deaths, 2 injuries.

The most frequently reported specific device problem is “Material Separation” (2 reports).

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

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• DeathFeb 12, 2021Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2020, THE PRESENTED FOR AXILLOFEMORAL BYPASS USING A GORE® PROPATEN® VASCULAR GRAFT. IT WAS REPORTED TEN DAYS POST OPERATIVE THE PATIENT EXPIRED. THE PHYSICIAN STATED THE PATIENT EXPIRED DUE TO MULTI ORGAN FAILURE AND HEMORRHAGIC SHOCK. THE PHYSICIAN ALSO STATED THE MULTI ORGAN FAILURE AND HEMORRHAGIC SHOCK WAS SUSPECTED TO HAVE BEEN CAUSED BY A COMPLETE TRANSECTION/DISRUPTION OF THE PROXIMAL END OF THE GRAFT 4CM DISTAL TO THE ANASTOMOSES.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11323226 ↗
• InjuryJan 19, 2021Material Separation; Material Separation

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2020, THE PATIENT PRESENTED WITH PERIPHERAL ARTERIAL DISEASE IN THE FEMORAL ARTERIES AND UNDERWENT AN AORTOBIFEMORAL BYPASS UTILIZING A GORE® PROPATEN® VASCULAR GRAFT. THE PHYSICIAN COMPLETED THE IMPLANTING PROCEDURE SUCCESSFULLY. WHILE THE PATIENT WAS IN POST OPERATIVE RECOVERY, IT WAS OBSERVED THAT THE PATIENT WAS BLEEDING AND WAS TAKEN BACK TO THE OPERATING ROOM. THE PHYSICIAN OBSERVED THAT THE GORE® PROPATEN® VASCULAR GRAFT APPEARED TORN FROM THE ANASTOMOSIS IN THE PROFUNDA POST OPERATIVELY. THE PHYSICIAN MADE THE FOLLOWING OBSERVATIONS: PART OF THE GORE® PROPATEN® VASCULAR GRAFT WAS STILL CONNECTED TO THE ARTERY, AND WHEN THE GORE® PROPATEN® VASCULAR GRAFT REPORTEDLY BROKE IT RETRACTED BACK INTO THE TUNNEL THAT WAS CREATED FOR PLACEMENT. THE PHYSICIAN THEN DECIDED TO LIGATE THE GORE® PROPATEN® VASCULAR GRAFT AND CLOSED OFF THE PROFUNDA. THE PROCEDURE WAS COMPLETED BY PERFORMING AN ABOVE KNEE AMPUTATION. THE PATIENT TOLERATED THE PROCEDURE AND IS REPORTED TO BE RECOVERING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Code Available

  MAUDE report 11194486 ↗
• DeathFeb 10, 2020Material Separation; Material Separation

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(4) 2019 AN 8MM GORE® PROPATEN® VASCULAR GRAFT WAS IMPLANTED AS A BYPASS, COMMON ILIAC TO DISTAL SFA. ON (B)(6) 2020 THE PHYSICIAN PERFORMED A RE-EXPLORATION AS A RESULT OF AN IDENTIFIED OCCLUSION WITHIN THE GRAFT. THE DOCTOR PERFORMED A GRAFT THROMBECTOMY AS WELL AS REVISION OF THE DISTAL ANASTOMOSIS, EXTENDING TREATMENT BY SEWING A SECOND GRAFT TO THE DISTAL ANASTOMOSIS TO THE POPLITEAL BELOW KNEE POSITION. ON (B)(6) THE GRAFT TO GRAFT ANASTOMOSIS DISRUPTED. ACCORDING TO THE DOCTOR, THE PATIENT BLED OUT VERY RAPIDLY AND EXPIRED.

  Patient problems: Death

  MAUDE report 9689891 ↗
• InjuryAug 15, 2018Complete Blockage; Complete Blockage

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2017, A GORE® PROPATEN® VASCULAR GRAFT WAS IMPLANTED IN AN ABOVE-KNEE FEMORO-POPLITEAL PROCEDURE. ON (B)(6) 2017, SEROMA WAS FOUND. ON (B)(6) 2017, THE SEROMA WAS EVACUATED WITH NEEDLE ASPIRATION. ON (B)(6) 2018 A FOLLOW-UP CT WAS PERFORMED. NO ACTION WAS TAKEN AT THIS TIME AND PHYSICIAN DECIDED TO MONITOR THE PATIENT FOR ANY CHANGES. ON (B)(6), THE PHYSICIAN REPORTED SEVERE SEROMA WAS OBSERVED THROUGH THE LENGTH OF THE GRAFT. ON (B)(6) 2018, THE GORE® PROPATEN® VASCULAR GRAFT WAS EXPLANTED.

  Patient problems: Seroma

  MAUDE report 7785471 ↗