COOK G47496Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10827002474960), received between Dec 16, 2022 and Dec 14, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 14, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE DEVICE WAS PLACED AND EVERYTHING APPEARED FINE. SOMEHOW, THE DEVICE GOT STUCK IN A COOK SHEATH OR A DRY-SEAL. IN ANY EVENT, THE STENT WAS PULLED OUT / THROUGH THE DRY-SEAL. AT THIS POINT, THE PHYSICIAN ELECTED TO OPEN UP A NEW ZDES-36-180 TO COMPLETE THE INTENDED PROCEDURE SUCCESSFULLY. ADDITIONAL INFORMATION RECEIVED ON 21AUG2023: PATIENT CAME IN EMERGENTLY AND WAS IN OPEN ASCENDING ARCH REPAIR FOR AORTIC DISSECTION FOR >6 HOURS PRIOR TO THE STENT GOING IN. STENT PLACEMENT WENT VERY QUICKLY. UNSURE IF STENT WAS CAUGHT IN ZDES SHEATH OR DRYSEAL SHEATH. TRIGGER WIRES REMOVED WITH EASE. DESPITE REQUEST, PHYSICIAN REMOVED POSITIONER AND COOK ZDES SHEATH WITHOUT WATCHING ON ANGIO AND DID SO VERY QUICKLY. EVERYTHING LOOKED GOOD UP UNTIL SHEATH/ POSITIONER REMOVAL. I REQUESTED THE PHYSICIAN TO WATCH THE DEVICE POSITIONER COME THROUGH THE STENT UNDER FLORO AND PHYSICIAN DID NOT USE FLORO AND PULLED COOK ZDES SHEATH AND POSITIONER OUT QUICKLY. I LOOKED FROM THE SCREEN TO THE TABLE IMMEDIATELY AFTER REQUESTING FLORO AND SAW THE STENT ON THE TABLE. THERE WAS VERY MINIMAL IMAGING AND HAPPENED VERY FAST. ZDES STENT CAME OUT WITH THE COOK

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18323937 ↗
• InjuryDec 19, 2022Malposition of Device; Migration; Malposition of Device; Migration

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE TEVAR COVERED PIECES WERE SUCCESSFULLY DEPLOYED TO COVER ENTRY TEARS TO APPROX. 2CM ABOVE CELIAC ARTERY. EXTENDED DISTALLY WITH ZDES-46-184-US. THE PHYSICIAN WAS ADVICED TO USE CAUTION ADVANCING ANY WIRES THROUGH THE BARE STENT AS THEY COULD GO THROUGH THE SUTURE LOOPS USED TO HOLD THE STENT TOGETHER, BUT HE SAID HE ADVANCED WIRES QUICKLY AND SAID THAT THERE WAS NO WAY TO TELL. AS IT WAS EXPLAINED TO THE FELLOW AND MDT REP WHY CAUTION WAS NEEDED, THE PHYSICIAN ADVANCED THE BERENSTEIN CATHETER OVER THE WIRE AT WHICH POINT THE DISTAL 2 STENTS OF THE ZDES MIGRATED UP. THE DOCTOR USED A MOLDING BALLOON (FROM ANOTHER MFG) THAT WAS GENTLY INFLATED INSIDE THE ZDES TO PULL THE STENT BACK DOWN INTO PLACE. PATIENT OUTCOME: THE STENT WAS IN A REASONABLE POSITION AFTER USING THE MOLDING BALLOON AND STAYED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16002218 ↗
• InjuryDec 16, 2022Migration; Migration

  ACCORDING TO THE INITIAL REPORTER: "THE TEVAR COVERED PIECES WERE SUCCESSFULLY DEPLOYED TO COVER ENTRY TEARS TO APPROX. 2CM ABOVE CELIAC ARTERY. EXTENDED DISTALLY WITH ZDES-46-184-US. I ADVISED THE DOCTOR TO USE CAUTION ADVANCING ANY WIRES THROUGH THE BARE STENT AS THEY COULD GO THROUGH THE SUTURE LOOPS USED TO HOLD THE STENT TOGETHER, BUT HE SAID HE ADVANCED WIRES QUICKLY AND SAID THAT THERE WAS NO WAY TO TELL. AS I WAS EXPLAINING TO THE FELLOW AND MDT REP WHY CAUTION WAS NEEDED THE DOCTOR ADVANCED THE (ANOTHER MANUFACTURERS) CATHETER OVER THE WIRE AT WHICH POINT THE DISTAL 2 STENTS OF THE ZDES MIGRATED UP (CEPHALAD). THE DOCTOR USED A MOLDING BALLOON (MDT RELIANT) THAT WAS GENTLY INFLATED INSIDE THE ZDES TO PULL THE STENT BACK DOWN INTO PLACE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15998588 ↗