BEUDAMED
    FDA Adverse Event Death Summary report: N

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

    MDR report key: 6646070 · Received June 16, 2017

    Report

    Report Number
    3002808486-2017-01296
    Event Type
    Death
    Date Received
    June 16, 2017
    Date of Event
    April 30, 2017
    Report Date
    May 22, 2017
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    PMA / PMN Number
    P140016
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    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. (B)(4). INVESTIGATION IS STILL IN PROGRESS.

    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: BASED ON THE IMAGING REVIEW SEVERE DISEASE OF THE DISTAL AORTA WAS OBSERVED IN ANEURYSM PROGRESSION DISTALLY DESPITE SUCCESSFUL ANEURYSM EXCLUSION. THIS WAS SEEN AS A STABLE PROXIMAL ENDOGRAFT, DISTAL ANEURYSM GROWTH, AND INCREASING DISTAL AORTIC LENGTH, TORTUOSITY, AND DIAMETER, EVENTUALLY ENGULFING THE DISTAL ENDOGRAFT. AT FOUR YEARS THE DISTAL SEAL ZONE AND THE AORTA DISTALLY HAD EXPANDED WELL BEYOND THE ENDOGRAFT DESIGN DIAMETER TO 47MM. A BREACHED SEAL ZONE AND TYPE IB ENDOLEAK OBSERVED AT FOUR YEARS EXPLAINS WHY THE ANEURYSM RUPTURED AT FIVE YEARS. BECAUSE THE DISTAL ANEURYSM GREW TOWARDS THE DISTAL ENDOGRAFT BEGINNING BETWEEN SIX AND 20 MONTHS, AMPLE OPPORTUNITY EXISTED TO EXTEND THE ENDOGRAFT BEFORE THE INEVITABLE SEAL ZONE BREACH OCCURRED. THE DISTAL GRAFT COULD HAVE BEEN EXTENDED WHEN THE ABDOMINAL AORTIC ANEURYSM WAS TREATED. NO EVIDENCE TO SUGGEST THAT THE PRODUCT WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT ACCORDING TO STUDY: ON (B)(6) 2012, THE PATIENT RECEIVED A ZTLP-PT-36-209-CI PROXIMAL COMPONENT. THERE WAS NO DIFFICULTY DEPLOYING THE DEVICES AND NO ADDITIONAL PROCEDURES WERE PERFORMED. ON THE COMPLETION ANGIOGRAM, THE SITE NOTED THAT THE DEVICES WERE PATENT WITH NO KINKS OR ENDOLEAKS. FURTHER ANALYSIS NOTED THAT THE DEVICES WERE PATENT, BUT NOTED BOTH A PROXIMAL TYPE I ENDOLEAK AND AN UNKNOWN TYPE II ENDOLEAK. NO KINKS WERE NOTED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2012 (THREE DAYS POST-PROCEDURE). FOLLOW-UP IMAGING: (B)(6) 2012 (1-MONTH FOLLOW-UP) (31 DAYS POST-PROCEDURE) CT SCAN. ANALYSIS: ANEURYSM DIAMETER 64 MM. DEVICES PATENT AND INTACT WITH NO KINKS OR ENDOLEAKS. ON (B)(6) 2012 (6-MONTH FOLLOW-UP) (171 DAYS POST-PROCEDURE) MRI. ANALYSIS: ANEURYSM DIAMETER 69 MM. DEVICES PATENT WITH NO KINKS. ON (B)(6) 2013 (12-MONTH FOLLOW-UP) (366 DAYS POST-PROCEDURE) MRI. ANALYSIS: ANEURYSM DIAMETER 71 MM. DEVICES PATENT WITH NO KINKS. ON (B)(6) 2013 (504 DAYS POST-PROCEDURE), THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN INFRARENAL AAA. ON (B)(6) 2014 (2-YEAR FOLLOW-UP) (737 DAYS POST-PROCEDURE) MRI ANALYSIS: ANEURYSM DIAMETER 70 MM. DEVICES PATENT AND INTACT WITH NO MIGRATION, KINKS, OR ENDOLEAKS. ON (B)(6) 2015 (3-YEAR FOLLOW-UP) (1109 DAYS POST-PROCEDURE) MRI. ANALYSIS: ANEURYSM DIAMETER 80 MM. DEVICES PATENT WITH NO KINKS OR ENDOLEAKS. ON (B)(6) 2016 (4-YEAR FOLLOW-UP) (1420 DAYS POST-PROCEDURE) MRI. ANALYSIS: ANEURYSM DIAMETER 83 MM. DEVICES PATENT WITH NO KINKS OR ENDOLEAKS. ON 25JUL2016 ¿ A LETTER WAS SENT TO THE IMPLANTING PHYSICIAN REGARDING THE INCREASE IN THE ANEURYSM DIAMETER NOTED. PRIOR TO THE 4-YEAR IMAGING, THE SITE AND ANALYSIS MEASUREMENTS HAD BEEN SHOWING THE SAME AMOUNT OF GROWTH. ON (B)(6) 2017 (1852 DAYS POST-PROCEDURE), THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO A HEMOTHORAX. ON (B)(6) 2017 (1853 DAYS POST-PROCEDURE), THE PATIENT REQUIRED MECHANICAL VENTILATION. ON THE SAME DAY, A CT SHOWED GROWTH IN THE THORACOABDOMINAL ANEURYSM. THE PATIENT BEGAN TO DECOMPENSATE IN ROUTE TO THE OR, AND DIED IN THE OR. NO SURGERY WAS PERFORMED. THE PATIENT WAS DIAGNOSED WITH HEMORRHAGIC SHOCK AND ANEMIA DUE TO ACUTE BLOOD LOSS FROM AORTIC RUPTURE. PATIENT OUTCOME: THE PATIENT DIED ON (B)(6) 2017 (1853 DAYS POST-PROCEDURE) OF AORTIC RUPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427883 ZENITH® TX2® LOW PROFILE TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death