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COOK G47485Recalls & reported problems

William Cook Europe ApS · Zenith TX2, Dissection Endovascular Graft with Pro-form, and the Z-Trak Plus Introduction System-Tapered Component · Class 3 · Implant

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002474854), received between May 31, 2022 and Aug 17, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (1 report).

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

Device problems

  • Difficult to Advance1
  • Failure to Advance1
  • Physical Resistance/Sticking1

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 17, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE TRIGGER WIRE RELEASE MECHANISM DID NOT DETACH FROM THE INTRODUCTION SYSTEM. THE GREEN TRIGGER WAS MUSCLED BACK AND PULL THE WIRES WITH HEMOSTATS - ONE AT A TIME. PATIENT OUTCOME: THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15238436 ↗
  • MalfunctionMay 31, 2022Failure to Advance; Difficult to Advance; Failure to Advance; Difficult to Advance

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: DEVICE WOULD NOT PASS THROUGH THE RIGHT COMMON ILIAC ARTERY. A LITTLE BIT OF CALCIFICATION AND TORTUOSITY. A DIFFERENT COOK DEVICE WAS USED. PATIENT OUTCOME: THE COMPLAINANT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14546072 ↗

Other SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT devices

All SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.