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Zenith TX2 Pro-Form G53447Recalls & reported problems

William Cook Europe ApS · Zenith TX2, TAA Endovascular Graft with Pro-Form, Proximal Tapered Component · Class 3 · Implant

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002534473), received between Oct 9, 2019 and Oct 18, 2019 — classified as 1 injury, 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

Device problems

  • Migration2

Patient problems

  • No Information2

Recent adverse event reports

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

  • InjuryOct 18, 2019Migration; Migration

    DESCRIPTION OF EVENT ACCORDING TO STUDY: ON (B)(6) 2014, THE PATIENT RECEIVED ZTEG-2PT-36-197-PF-US (LOT # E3219029) UNDER GENERAL ANESTHESIA. A CODA-2-10.0-35-120-40 (LOT # 4931829) MOLDING BALLOON WAS USED WITHOUT DIFFICULTY OR COMPLICATION. NO ADVERSE EVENTS WERE REPORTED RELATED TO THE IMPLANT PROCEDURE. THE PATIENT HAS BEEN FOLLOWED BY A SERIES OF CTS (DATES: (B)(6) 2014, (B)(6) 2015, (B)(6) 2017, (B)(6) 2018) WITH NO DEVICE RELATED ISSUES REPORTED. A (B)(6) 2019 CT REVEALED CAUDAD MIGRATION. CORE LAB NOTED, ¿CAUDAD (AT THE PROXIMAL END). L2 HAS INCREASED MORE THAN 10MM, AND THE 3D RECONSTRUCTIONS SHOW A CHANGE IN THE RELATIONSHIP OF THE DEVICE TO CALCIFICATION IN THE AORTIC WALL.¿ CORE LAB ALSO NOTED, ¿L2 HAS INCREASED MORE THAN 10MM, AND THE 3D RECONSTRUCTIONS SHOW A CHANGE IN THE RELATIONSHIP OF THE DEVICE TO CALCIFICATION IN THE AORTIC WALL. THE DEVICE HAS PARTIALLY OVERLAPPED THE 3RD AND 4TH STENTS OVER TIME AS ANGULATION DEVELOPED, WHICH APPEARS TO HAVE PULLED THE PROXIMAL ASPECT OF THE DEVICE IN A CAUDAD DIRECTION. L6 IS NOW ALSO >10MM INCREASED OVER THE 1 MONTH TIME POINT. IT IS NOT CLEAR THAT THIS IS DUE TO MIGRATION, AS NO DEFINITE ANATOMIC MARKERS ARE IDENTIFIED FOR

    Patient problems: No Information

    MAUDE report 9209153 ↗
  • MalfunctionOct 9, 2019Migration; Migration

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

    Patient problems: No Information

    MAUDE report 9171303 ↗

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Sources and updates

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