COOK G47467Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10827002474670), received between Feb 24, 2022 and May 1, 2024 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionMay 1, 2024

  WHILE UNSHEATHING GRAFT TO BEGIN FENESTRATIONS, SURGEON HAD DIFFICULTY GETTING GRAFT TO COME OUT. WHEN GRAFT FINALLY UNSHEATHED, SURGEON NOTICED THAT PART OF DEPLOYMENT SYSTEM WAS BROKEN RENDERING SYSTEM UNUSABLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19220094 ↗
• InjuryJun 16, 2022Entrapment of Device; Entrapment of Device

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: PHYSICIAN MODIFIED GRAFT AND CREATED 4 FENESTRATIONS FOR THE SYLIAC SMA LEFT AND RIGHT RENAL. THEY DEPLOYED THE GRAFT AND WERE ABLE TO GET OUT THE FENESTRATIONS AND WERE ABLE TO PLACE STENTS OUT THE FENESTRATIONS. BUT THEY HAD A SMALL DISECTION IN THE SILLIAC WHICH THEY WERE ABLE TO STENT AND FIX. THEN ANOTHER DISECTION IN THE SMA (SUPERIOR MESENTERIC ARTERY) WHICH THEY WERE NOT ABLE TO FIX RIGHT AWAY AND HAD TO GO IN AND DO A BYPASS ON. PATIENT OUTCOME: THE EVENT DID REQUIRE AN ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE: BYPASS THE PATIENT DID NOT REPORT ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE PATIENT WAS HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION DUE THIS OCCURRENCE: THERE PROBABLY WILL BE A LONGER THAN EXPECTED HOSPITAL STAY.

  Patient problems: Vascular Dissection

  MAUDE report 14712212 ↗
• InjuryJun 1, 2022Entrapment of Device; Off-Label Use; Entrapment of Device; Off-Label Use

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: PHYSICIAN MODIFIED GRAFT AND CREATED 4 FENESTRATIONS FOR THE SYLIAC SMA LEFT AND RIGHT RENAL. THEY DEPLOYED THE GRAFT AND WERE ABLE TO GET OUT THE FENESTRATIONS AND WERE ABLE TO PLACE STENTS OUT THE FENESTRATIONS. BUT THEY HAD A SMALL DISSECTION IN THE SILLIAC WHICH THEY WERE ABLE TO STENT AND FIX. THEN ANOTHER DISSECTION IN THE SMA (SUPERIOR MESENTERIC ARTERY) WHICH THEY WERE NOT ABLE TO FIX RIGHT AWAY AND HAD TO GO IN AND DO A BYPASS ON. PATIENT OUTCOME: THE EVENT DID REQUIRE AN ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE: BYPASS THE PATIENT DID NOT REPORT ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE PATIENT WAS HOSPITALIZED OR WAS THERE PROLONGED HOSPITALIZATION DUE THIS OCCURRENCE: THERE PROBABLY WILL BE A LONGER THAN EXPECTED HOSPITAL STAY.

  Patient problems: Vascular Dissection

  MAUDE report 14563966 ↗
• MalfunctionFeb 24, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE DELIVERY SYSTEM WAS PLACED IN AORTIC ARCH. THE PIN AND PULL STEP WAS PERFORMED WITHOUT EVENT. THE WHITE THUMB SCREW WAS UNSCREWED WITHOUT ISSUE. THE GREEN TRIGGER WIRE MECHANISM WAS ATTEMPTED TO BE PULLED TO RELEASE THE GRAFT. THE GREEN TRIGGER WIRE MECHANISM WOULD NOT MOVE AT ALL AND SEIZED ONTO THE DILATOR. MULTIPLE ATTEMPTS WERE MADE TO REMOVE THE GREEN TRIGGER WIRE MECHANISM WITH DIFFERENT USES OF LEVERAGE TO NO AVAIL. THEY THEN ATTEMPTED TO ROTATE THE GREEN TRIGGER WIRE MECHANISM TO RELEASE IT FROM THE DILATOR WITH NO SUCCESS. THE DILATOR WAS THEN UNSCREWED AND PULLED APART TO REVEAL THE TRIGGER WIRES. THE TRIGGER WIRES WERE THEN PULLED MANUALLY AND THE GRAFT WAS RELEASED BUT NOT BEFORE THE GRAFT WAS PULLED DISTALLY ABOUT 1 CM. A SECOND GRAFT WAS PLACED TO EXTEND THE SEAL PROXIMALLY. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. (B)(6) 2022 ADD INFO: PATIENT WAS HEPARINIZED. NO SIGNIFICANT CALCIFICATION OR TORTUOSITY. PATIENT OUTCOME: ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13589469 ↗