BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH® TX2® LOW PROFILE TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT

    MDR report key: 6621268 · Received June 8, 2017

    Report

    Report Number
    3002808486-2017-01259
    Event Type
    Injury
    Date Received
    June 8, 2017
    Date of Event
    April 14, 2017
    Report Date
    May 19, 2017
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002552262
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURER REF# (B)(4). G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. SUMMARY OF INVESTIGATIONAL FINDINGS: A VERY SMALL ARTERIAL PHASE ENDOLEAK REPRESENTING EITHER A TYPE 2 ENDOLEAK OR A TYPE 3 SUTURE HOLE ENDOLEAK WAS CONFIRMED. THE LEAK WAS VARIABLY VISIBLE THROUGHOUT THE FOLLOW UPS AND APPEARED ADJACENT TO THE ENDOGRAFT SURFACE, AT THE TRAILING EDGE OF A SECOND MAINBODY STENT, WHERE THE ENDOGRAFT FOLDED AS IT CONFORMED TO AORTIC TORTUOSITY. LTS LOCATION NEAR THE ENDOGRAFT SURFACE AND THE APPEARANCE AT 36 MONTHS SUGGESTING A PINHOLE ENDOLEAK ORIGINATING AT A STENT STRUT SUPPORTS A TYPE 3 SUTURE HOLE ENDOLEAK. THE FOLDED ENDOGRAFT FABRIC HAD A GREATER POTENTIAL TO ENLARGE THE SUTURE HOLES OVER TIME. THE STABLE ANEURYSM VOLUME INDICATES THAT THE LEAK IS STILL VERY SMALL OR A TYPE 2 ENDOLEAK. NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATION. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURER REF# (B)(4). D1) BRAND NAME: ZENITH® TX2® LOW PROFILE TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113 G5) SIMILAR TO DEVICE UNDER 510(K): P140016. (B)(4). INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT ACCORDING TO STUDY: ENDOLEAK OF UNKNOWN TYPE 5 YEARS POST-IMPLANT ON (B)(6) 2012, THE PATIENT RECEIVED ONE ZTLP-PT-38-167-CI PROXIMAL COMPONENT. THERE WAS NO DIFFICULTY DEPLOYING THE DEVICE. COIL EMBOLIZATION OF THE LEFT SUBCLAVIAN ARTERY WAS PERFORMED AFTER DEVICE DEPLOYMENT. ON THE COMPLETION ANGIOGRAM, THE CORE LAB NOTED THAT THE DEVICES WERE PATENT WITH NO KINK OR ENDOLEAK. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2012 (THREE DAYS POST-PROCEDURE). FOLLOW-UP CT SCANS ON (B)(6) 2012 (1-MONTH FOLLOW-UP, 23 DAYS POST-PROCEDURE) ANALYSIS: ULCER DEPTH 24 MM. DEVICES PATENT AND INTACT WITH NO KINKS OR ENDOLEAKS. ON (B)(6) 2012 (6-MONTH FOLLOW-UP, 186 DAYS POST-PROCEDURE) ANALYSIS: ULCER DEPTH 24 MM. DEVICES PATENT AND INTACT WITH NO MIGRATION, KINKS OR ENDOLEAKS. ON (B)(6) 2013 (12-MONTH FOLLOW-UP, 368 DAYS POST-PROCEDURE) ANALYSIS: ULCER DEPTH 25 MM. DEVICES PATENT AND INTACT WITH NO MIGRATION, KINKS OR ENDOLEAKS. ON (B)(6) 2014 (2-YEAR FOLLOW-UP, 732 DAYS POST-PROCEDURE) ANALYSIS: ULCER DEPTH 22 MM. DEVICES PATENT AND INTACT WITH NO MIGRATION, KINKS OR ENDOLEAKS. ON (B)(6) 2015 (3-YEAR FOLLOW-UP, 1082 DAYS POST-PROCEDURE) ANALYSIS: ULCER DEPTH 20 MM. DEVICES PATENT AND INTACT WITH NO MIGRATION, KINKS OR ENDOLEAKS. ON (B)(6) 2016 (4-YEAR FOLLOW-UP, 1460 DAYS POST-PROCEDURE) ANALYSIS: ULCER DEPTH 21 MM. DEVICES PATENT AND INTACT WITH NO MIGRATION, KINKS OR ENDOLEAKS. 1ON (B)(6) 2017 (5-YEAR FOLLOW-UP, 1817 DAYS POST-PROCEDURE) ANALYSIS: ULCER DEPTH 21 MM. DEVICES PATENT AND INTACT WITH NO MIGRATION OR KINKS. AN ENDOLEAK OF UNKNOWN TYPE WAS NOTED. PATIENT OUTCOME: THE PATIENT HAS COMPLETED THE 5-YEAR FOLLOW-UP AND HAS EXITED THE STUDY. NO ADVERSE EVENTS RELATED TO THE DEVICE HAVE BEEN REPORTED AND SECONDARY INTERVENTIONS HAVE BEEN PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404616 ZENITH® TX2® LOW PROFILE TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE G55226 10827002552262

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Life Threatening