COOK G47493Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10827002474939), received between Oct 5, 2020 and Jan 11, 2023 — classified as 3 deaths, 6 injuries.

The most frequently reported specific device problem is “Malposition of Device” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJan 11, 2023Malposition of Device; Malposition of Device

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: PATIENT CAME IN FOR A DISSECTION EMERGENT CASE. DURING DEPLOYMENT OR USER AGGRESSION THE GRAFT LANDED DISTAL TO WHERE THE ACTUAL APPROX LANDING ZONE WANTED TO BE ((B)(4)). THE PHYSICIAN DECIDED TO USE A DEVICE FROM ANOTHER MANUFACTURER TO GET MORE OF A PROXIMAL SEAL, DELIVERED THE DEVICE THEN DISTALITY HE EXTENDED OUT THE ZDES-36-180-US UPON FINAL RUN HE WAS SATISFIED WITH THE FINAL ANGIO. FAST FORWARD TO RECENTLY WITHIN THE LAST WEEK THE PATIENT HAD TO COME BACK IN WITH A TYPE A DISSECTION TO WHERE THEY HAD TO BUILD THE ARCH ((B)(4)). PATIENT OUTCOME: THE PATIENT WAS PROLONGED HOSPITALIZED FOR RECOVERY. FURTHERMORE, THE PATIENT HAD TO RETURN FOR COMPLETE ARCH REPAIR.

  Patient problems: Vascular Dissection

  MAUDE report 16136975 ↗
• InjuryAug 5, 2022Unintended System Motion; Unintended System Motion

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE GREEN TRIGGER WIRE MECHANISM GAVE RESISTANCE AS THE OPERATOR ATTEMPTED TO REMOVE IT FROM THE DELIVERY SYSTEM, CAUSING THE GREY POSITIONER TO MOVE AND DISPLACE THE STENT DISTALLY BY ~5MM AS EVIDENCED BY LIVE FLUORO IMAGING. AFTER REMOVING THE GREEN TRIGGER WIRE, THE OPERATORS RETRACTED THE GREY POSITIONER (DILATOR SYSTEM) UNTIL IT MARRIED INTO THE SHEATH AS GUIDED BY LIVE FLUORO IMAGING WITH NO EVIDENCE OF STENT MOVEMENT. HOWEVER, UPON REMOVING THE ENTIRE DELIVERY SYSTEM (SHEATH AND GREY POSITIONER) FOR A 16FR SHEATH EXCHANGE, THE STENT MIGRATED DISTALLY BY ~6CM UNTIL THE STENT WAS RESTED ENTIRELY ON THE AORTIC BI-FURCATION. PATIENT OUTCOME: DEVICE WAS MEANT TO BE IMPLANTED BUT THE STENT MIGRATED FROM DESIRED LANDING LOCATION. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15174867 ↗
• InjuryAug 1, 2022Unintended System Motion; Physical Resistance/Sticking; Unintended System Motion; Physical Resistance/Sticking

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE GREEN TRIGGER WIRE MECHANISM GAVE RESISTANCE AS THE OPERATOR ATTEMPTED TO REMOVE IT FROM THE DELIVERY SYSTEM, CAUSING THE GREY POSITIONER TO MOVE AND DISPLACE THE STENT DISTALLY BY ~5MM AS EVIDENCED BY LIVE FLUORO IMAGING. AFTER REMOVING THE GREEN TRIGGER WIRE, THE OPERATORS RETRACTED THE GREY POSITIONER (DILATOR SYSTEM) UNTIL IT MARRIED INTO THE SHEATH AS GUIDED BY LIVE FLUORO IMAGING WITH NO EVIDENCE OF STENT MOVEMENT. HOWEVER, UPON REMOVING THE ENTIRE DELIVERY SYSTEM (SHEATH AND GREY POSITIONER) FOR A 16FR SHEATH EXCHANGE, THE STENT MIGRATED DISTALLY BY ~6CM UNTIL THE STENT WAS RESTED ENTIRELY ON THE AORTIC BI-FURCATION. PATIENT OUTCOME: DEVICE WAS MEANT TO BE IMPLANTED BUT THE STENT MIGRATED FROM DESIRED LANDING LOCATION. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15137870 ↗
• InjuryApr 12, 2022Mechanical Jam; Physical Resistance/Sticking; Mechanical Jam; Physical Resistance/Sticking

  ACCORDING TO THE INITIAL REPORTER: COULD NOT GET THE TRIGGER WIRES RELEASED FROM THE DELIVERY SYSTEM. THEREFORE, WHILE ATTEMPTING TO PULL THE TRIGGER WIRES OUT, THE WHOLE DEVICE CAME BACK WITH IT. THIS GRAFT WAS STILL USED AND IMPLANTED. A CODA BALLOON WAS USED TO TRY AND PUSH-UP THE ZDES. ADDITIONAL INFORMATION 07APR2022: THE ZDES LANDED ABOUT 1 CM BELOW THE AORTIC BIFURCATION, IN THE RIGHT COMMON ILIAC. THE TARGET LANDING ZONE WAS ABOUT 1 CM ABOVE THE AORTIC BIFURCATION. IT WAS A BARE METAL STENT THAT DID NOT LAND IN THE TARGET LOCATION; THEREFORE, WE WERE NOT CONCERNED WITH ENDOLEAKS. THE WHITE KNOB ON THE GREEN TRIGGER WIRE RELEASE KNOB WAS COMPLETELY REMOVED, THEN THE PHYSICIAN TRIED TO PULL THE GREEN TRIGGER WIRE RELEASE KNOB OUT (RELEASING THE ZDES FROM THE DELIVERY SYSTEM). WHEN THE PHYSICIAN TRIED TO PULL OUT THE TRIGGER WIRES, THE ENTIRE DELIVERY SYSTEM (SHEATH, GRAY POSITIONER) CAME BACK INCLUDING THE ZDES. THE GREEN TRIGGER WIRE RELEASE KNOB WAS STUCK. IT TOOK THREE PEOPLE TRYING TO PULL BACK ON THE GREEN KNOB BEFORE IT FINALLY RELEASED FROM THE DELIVERY SYSTEM. THE PHYSICIAN DEPLOYED THE ZDES JUST ABOVE THE AORTIC BIFURCATION. AFTER ALL THE STENTS WERE DEPLOYED, HE TOO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14081829 ↗
• InjuryFeb 24, 2022Break; Break

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: WHILE TRYING TO REMOVE THE TRIGGER WIRES, THEY COULD NOT BE REMOVED - AND FOR THIS REASON THE DEVICE TWISTED. THE WIRES WERE EVENTUALLY REMOVED AFTER SOME MANIPULATION. THE GRAFT WAS DELIVERED AND IMPLANTED SUCCESSFULLY." (B)(4). ADDITIONAL INFORMATION RECEIVED ON 31JAN2022: THE TOP CAP HAS NOT BEEN RETRIEVED. (B)(4). DEVICES USED OR IMPLANTED DURING THE PROCEDURE: ZTA-P-36-209-ZT, LOT# E4144964, CODA-2-9.0-35-120-32, AND ARGON MEDICAL DEVICES ATRIEVE VASCULAR SNARE KIT. PETTICOAT WAS ADVANCED FROM FEMORAL ACCESS TO THE DESIRED LOCATION IN THE THORACIC AORTA. ONCE THREE STENTS OF OVERLAP WAS ACHIEVED, THE ANTI-TORQUE WAS RELEASED. THE DEVICE WAS THEM UNSHEATHED TO THE DISTAL END. THE PHYSICIAN ATTEMPTED TO RELEASE TRIGGER WIRES VIA UNSCREWING THE WHITE THUMB SCREW AND PULLING BACK ON THE GREEN TRIGGER WIRE HANDLE BUT WAS UNSUCCESSFUL. AFTER MULTIPLE ATTEMPTS OF TRYING TO REMOVE THE GREEN WIRE HANDLE, THE PHYSICIAN UNSCREWED THE WHITE CAP TO EXPOSE THE INNER CANNULA AND TRIGGER WIRE LUMEN. HE WAS THEN ABLE TO PULL BACK ON THE TRIGGER WIRES DIRECTLY WITH SNAPS. PATIENT OUTCOME:. PART OF THE DELIVERY SYSTEM REMAIN INSIDE THE PATIENT'

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13589482 ↗
• InjuryJan 12, 2022Mechanical Jam; Mechanical Jam

  DESCRIPTION OF EVENT ACCRODING TO INITIAL REPORTER: WHILE TRYING TO REMOVE THE TRIGGER WIRES, THEY COULD NOT BE REMOVED - AND FOR THIS REASON THE DEVICE TWISTED. THE WIRES WERE EVENTUALLY REMOVED AFTER SOME MANIPULATION. THE GRAFT WAS DELIVERED AND IMPLANTED SUCCESSFULLY. PATIENT OUTCOME: PART OF THE DELIVERY SYSTEM REMAIN INSIDE THE PATIENT'S BODY. THE GREY POSITIONERS' TOP CAP REMAINS INSIDE THE PATIENT. AFTER THE INITIAL PROCEDURE, THE PATIENT RECOVERED THAT WEEK. 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 OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13236226 ↗
• DeathDec 30, 2021Mechanical Jam; Physical Resistance/Sticking; Mechanical Jam; Physical Resistance/Sticking

  ADDITIONAL INFORMATION FROM MEETING 29MAR2022. A PETTICOAT PROCEDURE WAS PERFORMED IN WHICH A ZDEG DEVICE WAS PLACED SUCCESSFULLY FOLLOWED BY A ZDES DEVICE (COMPLAINT DEVICE). WHEN TRYING TO TAKE OF THE TRIGGER WIRE IT WASN¿T PULLING OFF. ONE PHYSICIAN TRIED, BUT THOUGHT IT WAS STUCK. ALL FOCUS CHANGED TO THE DELIVERY SYSTEM. THEY WERE TRYING TO REMOVE THE GREEN HANDLE KNOB AND TRYING A LOT, WITHOUT SUCCESS. A SECOND SURGEON TRIED TO NO AVAIL. WHILE MANIPULATING THE SYSTEM, THE DELIVERY SYSTEM TURNED AND TWISTED WHICH CAUSED THE STENT TO CANDY WRAP/HOUGLASS. NO ONE NOTICED THIS BECAUSE THEY WERE FOCUSING ON THE DELIVERY SYSTEM ENTIRELY. THAT SECTION OF THE STENT WAS NOT IN THE FLUORO. PETTICOAT MIGHT HAVE GONE DOWN TO CELIAC. WHILE MANIPULATING THEY COULDN´T IDENTIFY THE CAUSE OF ISSUE WITH THE GREEN TRIGGER KNOB. MD'S WERE ADVISED TO REMOVE GREEN KNOB AND REMOVE THE TRIGGER WIRES MANUALLY. THE TRIGGER WIRES CAME OFF. WHEN PULLING OUT THE GREY DELIVERY SYSTEM PART (GREY POSITIONER) THE STENT WAS TWISTED AS CANDY WRAP. THE DILATOR COULDN¿T RELEASE FROM THE STENT, WHERE THE STENT WAS CANDY WRAPPED. THE STENT WAS FULLY RELEASED FROM THE DELIVERY SYSTEM, WHEN TRYING TO PULL OUT THE DEL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13117508 ↗
• DeathOct 14, 2020Malposition of Device; Malposition of Device

  IT WAS FURTHER REPORTED: LOCATION OF THE PRIMARY ENTRY TEAR DISTAL TO THE LEFT SUBCLAVIAN ARTERY (LSA). DISSECTION EXTENDED FROM JUST DISTAL TO LSA DOWN INTO THE ILIACS, WITH A KNOWN RUPTURE IN THE THORACIC AORTA. ZDEG WAS PLACED PROXIMALLY AT THE DISTAL EDGE OF THE LEFT COMMON CAROTID ARTERY AND DISTALLY IN THE MID-DESCENDING THORACIC AORTA (6-8CM ABOVE THE CELIAC). ZDES WAS PLACED INSIDE THE ZDEG PROXIMALLY AND EXTENDED INTO THE MID ABDOMINAL AORTA. THE RUPTURE THAT WAS TREATED IN THE FIRST CASE, BUT NOT SEEN ON FINAL ANGIO AT THE END OF THE FIRST CASE, WAS AGAIN SHOWN TO HAVE EXTRAVASATION BEING FED FROM FALSE LUMEN FILLING DISTAL TO THE ZDEG. THE ZDES ACCORDIONED OCCURRED WHEN ATTEMPTING TO DELIVER THE ALPHA DEVICE. IT SEEMED TO GET CAUGHT ON THE BARE STENT AND WHEN RECOGNIZED THAT WAS THE RESISTANCE, THE STENT HAD KINKED MOVED OUT AND UP. ZENITH ALPHA DEVICE WS PLACED PROXIMALLY INTO THE ZDEG, DISTALLY BELOW THE ZDES AND BELIEVED TO BE ABOUT THE LEVEL OF THE CELIAC. CHOSE TO COVER AND TRY TO EXCLUDE RUPTURE AS QUICKLY AS POSSIBLE AS CPR HAD BEEN ON GOING FOR AN EXTENDED PERIOD OF TIME, SO NO CONFORMATION ANGIO WAS DONE PRIOR TO PLACEMENT.

  Patient problems: Death; No Code Available

  MAUDE report 10680183 ↗
• DeathOct 5, 2020Malposition of Device; Malposition of Device

  ADDITIONAL INFORMATION RECEIVED 16OCT2020: LOCATION OF THE PRIMARY ENTRY TEAR DISTAL TO THE LEFT SUBCLAVIAN ARTERY (LSA) DISSECTION EXTENDED FROM JUST DISTAL TO LSA DOWN INTO THE ILIACS, WITH A KNOWN RUPTURE IN THE THORACIC AORTA. ZDEG WAS PLACED PROXIMALLY AT THE DISTAL EDGE OF THE LEFT COMMON CAROTID ARTERY AND DISTALLY IN THE MID-DESCENDING THORACIC AORTA(6-8CM ABOVE THE CELIAC). ZDES WAS PLACED INSIDE THE ZDEG PROXIMALLY AND EXTENDED INTO THE MID ABDOMINAL AORTA. THE RUPTURE THAT WAS TREATED IN THE FIRST CASE, BUT NOT SEEN ON FINAL ANGIO AT THE END OF THE FIRST CASE, WAS AGAIN SHOWN TO HAVE EXTRAVASATION BEING FED FROM FALSE LUMEN FILLING DISTAL TO THE ZDEG. THE ZDES ACCORDIONED OCCURRED WHEN ATTEMPTING TO DELIVER THE ALPHA DEVICE. IT SEEMED TO GET CAUGHT ON THE BARE STENT AND WHEN RECOGNIZED THAT WAS THE RESISTANCE, THE STENT HAD KINKED MOVED OUT AND UP. ZENITH ALPHA DEVICE WAS PLACED PROXIMALLY INTO THE ZDEG, DISTALLY BELOW THE ZDES AND BELIEVED TO BE ABOUT THE LEVEL OF THE CELIAC. CHOSE TO COVER AND TRY TO EXCLUDE RUPTURE AS QUICKLY AS POSSIBLE AS CPR HAD BEEN ON GOING FOR AN EXTENDED PERIOD OF TIME, SO NO CONFORMATION ANGIO WAS DONE PRIOR TO PLACEMENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Death; No Code Available

  MAUDE report 10626046 ↗