GORE-TEX Cardiovascular Patch 1705007506Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132600656), received between Sep 10, 2018 and Sep 10, 2018 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2018, THE PATIENT WAS IMPLANTED WITH A GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PHYSICIAN MET RESISTANCE WHILE ADVANCING A GORE® DRYSEAL FLEX SHEATH (DSF1833/[(B)(4)] 18069588), HOWEVER HE WAS EVENTUALLY ABLE TO ADVANCE THE FLEX SHEATH WHERE IT WAS NEEDED. AFTER THE GORE® EXCLUDER® AAA ENDOPROSTHESES WERE IMPLANTED SUCCESSFULLY, THE PHYSICIAN BALLOONED THE ENTIRE GRAFT. THE PATIENT BECAME UNSTABLE AND EXPERIENCED A CARDIAC TAMPONADE. THE PHYSICIAN OPENED THE PATIENT AND FOUND THE PATIENT WAS BLEEDING FROM THE LUMBAR ARTERIES, HE BELIEVES THAT DURING THE PROCEDURE CALCIUM BECAME DISLODGED AND LACERATED THE ILIOLUMBAR ARTERY WHICH EXTENDED INTO THE ANEURYSM SAC. THE PHYSICIAN CHOSE TO EXPLANT THE GORE® EXCLUDER® AAA ENDOPROSTHESES AND PERFORM AN OPEN REPAIR. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 7862966 ↗