BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH ®TX2® LOW PROFILE TAA ENDOVASCULAR GRAFT PROXIMAL COMPONENT

    MDR report key: 6394181 · Received March 10, 2017

    Report

    Report Number
    3002808486-2017-00763
    Event Type
    Injury
    Date Received
    March 10, 2017
    Date of Event
    February 19, 2016
    Report Date
    May 2, 2016
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SIMILAR TO DEVICE UNDER 510(K): P140016. SUMMARY OF INVESTIGATIONAL FINDINGS: ACCORDING TO THE PROVIDED IMAGING, IT WAS POSSIBLE TO CONFIRM AORTIC ELONGATION WITH NO EVIDENCE OF MIGRATION. DESCENDING THORACIC AORTIC ELONGATION POST-REPAIR WITH PROGRESSIVE LENGTHENING OF THE DISTAL GRAFT POSITION AND THE DISTANCE BETWEEN THE DISTAL GRAFT AND CELIAC ARTERY. THE INCREASING DISTANCE BETWEEN THE GRAFT AND CELIAC ARTERY IS LESS LIKELY TO BE CRANIAL GRAFT MIGRATION AS THERE IS A CORRESPONDING INCREASE IN DISTANCE FROM THE CELIAC ARTERY TO THE LSA AS WELL. IN FACT, THERE IS MORE CONCERN FOR CAUDAL GRAFT MIGRATION DISTALLY BECAUSE THE DISTANCE FROM THE LSA TO DISTAL GRAFT HAS INCREASED. HOWEVER, AGAIN, THIS CORRESPONDS TO INCREASING AORTIC LENGTH AS OPPOSED TO MIGRATION. WITH THE LENGTHENING AORTA THERE IS ALSO CORRESPONDING INCREASED ANGULATION OF THE STENT GRAFT SEGMENT WITH SIGNIFICANT STENT SEGMENT COMPRESSION BETWEEN THE 5TH AND 7TH STENTS ALONG THE ACUTE ANGLE OF THE CURVE. NO EVIDENCE TO SUGGEST THAT THIS DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THIS (B)(6) FEMALE PATIENT IN THE THORACIC LOW PROFILE CLINICAL STUDY WAS NOTED BY THE CORE LAB TO HAVE CRANIAL MIGRATION OF THE PROXIMAL COMPONENT ON THE 4-YEAR FOLLOW-UP CT. ON (B)(6) 2012, A PROXIMAL COMPONENT (ZTLP-P-32-155-CI; LOT # E2837074) AND A DISTAL EXTENSION ((B)(4); LOT # E2837183) WERE IMPLANTED WITHOUT DIFFICULTY. ON THE COMPLETION ANGIOGRAM, THE SITE NOTED THAT THE DEVICES WERE PATENT WITH NO KINKS AND AN UNKNOWN TYPE OF ENDOLEAK. FOLLOW-UP CT¿S: ON (B)(6) 2012 (34 DAYS PP); CORE LAB: ANEURYSM DIAMETER 62 MM; DEVICES PATENT AND INTACT WITH NO KINKS OR ENDOLEAKS. ON (B)(6) 2012 (183 DAYS PP); CORE LAB: ANEURYSM DIAMETER 65 MM; DEVICES PATENT AND INTACT WITH NO MIGRATION, KINKS, OR ENDOLEAKS. ON (B)(6) 2013 (365 DAYS PP); CORE LAB: ANEURYSM DIAMETER 54 MM; DEVICES PATENT AND INTACT WITH NO MIGRATION, KINKS, OR ENDOLEAKS. ON (B)(6) 2014 (729 DAYS PP); CORE LAB: ANEURYSM DIAMETER 51 MM. DEVICES PATENT AND INTACT WITH NO MIGRATION, KINKS OR ENDOLEAKS. THE CORE LAB NOTED THAT ¿A NEW ANEURYSM HAS DEVELOPED AT THE CRANIAL END OF THE ENDOGRAFT ORIGINATING FROM THE UNCOVERED PORTION OF THE GRAFT UP TO THE AORTIC ARCH.¿ THEY ALSO NOTED THAT ¿THERE IS APPROXIMATELY A 13 MM DIFFERENCE ON THE L6 AND L7 MEASUREMENTS FROM TIMEPOINT 12 CT TO 24CT. THIS IS DUE TO DISTAL AORTIC ELONGATION OF 13 MM.¿ ON (B)(6) 2015 (1100 DAYS PP); CORE LAB: ANEURYSM DIAMETER 50 MM. DEVICES PATENT AND INTACT WITH NO MIGRATION, KINKS, OR ENDOLEAKS. THE CORE LAB NOTED THAT ¿CONTINUED INCREASE IN L6, L7, L10 DUE TO INFRA-GRAFT AORTIC LENGTHENING.¿ ON (B)(6) 2016 (1457 DAYS PP); CORE LAB: ANEURYSM DIAMETER 53 MM. DEVICES PATENT AND INTACT WITH NO KINKS OR ENDOLEAKS. THE CORE LAB NOTED THAT: ¿THERE IS CONTINUED LENGTHENING OF L6 AND LL7, AS WELL AS INCREASE IN L10. THE LENGTHENING OF THE AORTA APPEARS TO BE AT THE LEVEL OF THE TAA, AND THERE IS INCREASING ACUTE ANGULATION AT THE LEVEL OF THE DISTAL TAA. WHILE IT CAN BE DIFFICULT TO DIFFERENTIATE DEVICE MIGRATION WHEN THERE IS ALSO AORTIC LENGTHENING, THE 3D IMAGES DO SHOW THAT THE DISTAL ASPECT OF THE DEVICE NOW LIES ABOVE AN AORTIC ANGLE THAT WAS PRESENT AT 1 MONTH, AND ALSO NOW SITS IN A LARGER SEGMENT OF THE AORTA THAN AT 1 MONTH, SUGGESTING THAT THE DEVICE HAS MIGRATED CRANIAD FROM THE CAUDAL END, RELAXING INTO THE ANEURYSM SAC AND TAKING ON THE INCREASED ANGULATION OF THE AORTA. WITH THE OVERALL LENGTHENING, THE DISTAL GRAFT HAS ALSO BECOME MORE ANGULATED, MAKING MEASUREMENT OF D11 NOW AT A LEVEL OF FAIRLY ACUTE ANGULATION. THIS MAKES ACCURATE MEASUREMENT OF D11 TECHNICALLY DIFFICULT.¿ PATIENT OUTCOME: THIS CASE WAS SENT TO (B)(4) FOR MIGRATION ON 19MAY2016 AND WAS ADJUDICATED AS NO MIGRATION ¿ AORTIC ELONGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178384 ZENITH ®TX2® LOW PROFILE TAA ENDOVASCULAR GRAFT PROXIMAL COMPONENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Life Threatening