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COOK G47457Recalls & reported problems

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

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

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002474571), received between Apr 22, 2020 and May 5, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Difficult or Delayed Activation” (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

Device problems

  • Difficult or Delayed Activation2
  • Positioning Failure2
  • Physical Resistance/Sticking1

Patient problems

  • No Known Impact Or Consequence To Patient2
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • InjuryMay 5, 2020Positioning Failure; Difficult or Delayed Activation; Physical Resistance/Sticking; Positioning Failure; Difficult or Delayed Activation; 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; No Known Impact Or Consequence To Patient

    MAUDE report 10022990 ↗
  • InjuryApr 22, 2020Positioning Failure; Difficult or Delayed Activation; Positioning Failure; Difficult or Delayed Activation

    ACCORDING TO THE INITIAL REPORTER: "GREEN TRIGGER WIRE WAS DIFFICULT TO PULL OUT, AND WHEN IT WAS PULLED OUT THE GRAFT MIGRATED BACK; DEVICE WAS REMOVED FROM PATIENT, AND ANOTHER GRAFT (ALPHA) HAD TO BE PLACED IN THE ORIGINALLY INTENDED LOCATION. THE THIRD GRAFT WAS ALREADY PLANNED AS PART OF THE PROCEDURE. DM BELIEVES ADHESIVE MAY HAVE BEEN A CONTRIBUTING FACTOR (LIKE IT WAS STUCK TOGETHER)."

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 9987941 ↗

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.