Skip to content

COOK G47480Recalls & 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
2
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002474809), received between Sep 28, 2021 and Oct 1, 2021 — classified as 2 deaths.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (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

  • Physical Resistance/Sticking2

Patient problems

  • No Clinical Signs, Symptoms or Conditions2
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
  • Insufficient Information1

Recent adverse event reports

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

  • DeathOct 1, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: DIFFICULT REMOVING THE TRIGGING WIRES. THE GRAFT JUMPED BACK REALLY FAR ACCORDING TO THE CT. THE PHYSICIAN WAS ABLE TO RE-ADVANCE IT AND GET THE GRAFT WITHIN 5MM'S OF THE INTENDED TARGET LANDING ZONE. DURING THIS PROCESS, ONE OF THE STENTS ENFOLDED ON ITSELF (THIS CAUSED A LOSS OF GRAFT LENGTH). THE GRAFT WAS ULTIMATELY PLACED SUCCESSFULLY AND LAID FLAT ACCORDING TO FOLLOW-UP CT IMAGES. 21SEP2021: ADDITIONAL INFO RECEIVED: ONCE THE SAFETY PORTION WAS UNSCREWED, THE WIRE WOULD NOT RELEASE OUT OF THE DEVISE. THE PHYSICIAN HAD TO PULL EXTREMELY HARD TO REMOVE THEM. PATIENT OUTCOME: HAD TO GO BACK COUPLE DAYS LATER DUE TO LEAK. THE PHYSICIAN HAD TO PERFORM A FULL DE-BRANCHING. AN ADDITIONAL STENT WAS PLACED. HAD A HARD TIME WAKING THE PATIENT UP. THE FINAL OUTCOME IS THAT THE PATIENT DID NOT SURVIVE. THE PATIENT EXPIRED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12562649 ↗
  • DeathSep 28, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

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

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

    MAUDE report 12539181 ↗

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.