COOK G47452Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10827002474526), received between Aug 10, 2021 and Nov 9, 2022 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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.

• MalfunctionNov 9, 2022Improper or Incorrect Procedure or Method; Physical Resistance/Sticking; Improper or Incorrect Procedure or Method; Physical Resistance/Sticking

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15757753 ↗
• InjuryFeb 16, 2022No Apparent Adverse Event; No Apparent Adverse Event

  DESCRIPTION OF EVENT ACCORDING TO THE INITIAL REPORTER: PATIENT CAME IN EMERGENTLY DUE TO RUPTURE ((B)(4)) THE FIRST DEVICE (G47452, LOT E4201640) DID NOT LAND IN THE RIGHT PLACE DUE TO OPERATOR ERROR. A LACK OF UPWARD FORCE IN HOLDING THE DEVICE INTO POSITION CAUSED THE PROBLEM. ((B)(4)) THEY HAD TO USE SECOND DEVICE (G47451, LOT E4202793) BECAUSE THE FIRST DEVICE WAS NOT IN THE PROPER PLACE. WHEN THEY TRIED TO USE THE SECOND DEVICE, THE TRIGGER WIRES COULD NOT BE PULLED OUT. THEY USED AS MUCH FORCE AS THEY COULD USE. THEY THEN INTENTIONALLY BROKE APART THE DEVICE TO GET AHOLD OF THE WIRES TO RELEASE THE GRAFT FROM THE DELIVERY SYSTEM. WHILE RETRACTING THE WIRES, THE GRAFT WAS PUSHED BACK OUT OF PLACE BY BLOOD FLOW FORCES. IT WAS NOT SITTING CORRECTLY WITHIN THE FIRST DEVICE. ((B)(4)) A THIRD DEVICE (G47470, LOT E3923818) WOULD NOT TRACK UP BECAUSE OF THE WAY THAT THE SECOND DEVICE WAS PLACED. THE PROCEDURE WAS THEN ABORTED. THE PATIENT LOST 1.5 UNITS OF BLOOD AND DID NOT ACHIEVE PROXIMAL SEAL. PATIENT OUTCOME: NO INFORMATION REGARDING THE PATIENT OUTCOME HAS BEEN RECEIVED. NO UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13545711 ↗
• InjuryJan 31, 2022Improper or Incorrect Procedure or Method; No Apparent Adverse Event; Improper or Incorrect Procedure or Method; No Apparent Adverse Event

  DESCRIPTION OF EVENT ACCORDING TO THE INITIAL REPORTER: PATIENT CAME IN EMERGENTLY DUE TO RUPTURE ((B)(4)) THE FIRST DEVICE (G47452, LOT E4201640) DID NOT LAND IN THE RIGHT PLACE DUE TO OPERATOR ERROR. A LACK OF UPWARD FORCE IN HOLDING THE DEVICE INTO POSITION CAUSED THE PROBLEM. ((B)(4)) THEY HAD TO USE SECOND DEVICE (G47451, LOT E4202793) BECAUSE THE FIRST DEVICE WAS NOT IN THE PROPER PLACE. WHEN THEY TRIED TO USE THE SECOND DEVICE, THE TRIGGER WIRES COULD NOT BE PULLED OUT. THEY USED AS MUCH FORCE AS THEY COULD USE. THEY THEN INTENTIONALLY BROKE APART THE DEVICE TO GET AHOLD OF THE WIRES TO RELEASE THE GRAFT FROM THE DELIVERY SYSTEM. WHILE RETRACTING THE WIRES, THE GRAFT WAS PUSHED BACK OUT OF PLACE BY BLOOD FLOW FORCES. IT WAS NOT SITTING CORRECTLY WITHIN THE FIRST DEVICE. ((B)(4)) A THIRD DEVICE (G47470, LOT E3923818) WOULD NOT TRACK UP BECAUSE OF THE WAY THAT THE SECOND DEVICE WAS PLACED. THE PROCEDURE WAS THEN ABORTED. THE PATIENT LOST 1.5 UNITS OF BLOOD AND DID NOT ACHIEVE PROXIMAL SEAL. PATIENT OUTCOME: NO INFORMATION REGARDING THE PATIENT OUTCOME HAS BEEN RECEIVED. NO UNINTENDED SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13402205 ↗
• InjuryAug 10, 2021Entrapment of Device; Material Puncture/Hole; Entrapment of Device; Material Puncture/Hole

  ADDITIONAL INFORMATION RECEIVED 15SEP2021: FOLLOW UP CT DONE 21JUL2021. THERE IS A LEAK ON THE FOLLOW UP CT SCAN. BECAUSE OF LOCATION OF LEAK, THE PHYSICIAN IS INSISTENT IT IS A TEAR RATHER THAN A TYPE 2 OR 3. MINIMAL TO NO CALCIFICATION AND/OR VESSEL TORTUOSITY. LIKELY PLANNING FOR IMPLANTING AN ADDITIONAL GRAFT, BUT HAS NOT HAPPENED YET.

  Patient problems: Insufficient Information; Vascular Dissection

  MAUDE report 12299087 ↗