BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT

    MDR report key: 3954767 · Received July 18, 2014

    Report

    Report Number
    3002808486-2014-00031
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    May 12, 2014
    Report Date
    June 19, 2014
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    PMA / PMN Number
    P070016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON (B)(6) 2014 (46 DAYS POST-PROCEDURE), THE PATIENT WAS HOSPITALIZED WITH ACUTE MID-SCAPULAR BACK PAIN. THE PATIENT HAD A KNOWN TYPE I ENDOLEAK AND POORLY CONTROLLED BLOOD PRESSURE. A REPEAT CT SCAN SHOWED A PATENT, INTACT ENDOGRAFT WITH A PROXIMAL TYPE I ENDOLEAK. DUE TO A PERSISTENT PROXIMAL TYPE I ENDOLEAK, PSEUDOANEURYSM, AND RETROGRADE AORTIC DISSECTION, THE PATIENT UNDERWENT A TWO-STAGE SECONDARY INTERVENTION. ON (B)(6) 2014 (112 DAYS POST-PROCEDURE), THE PATIENT UNDERWENT A RIGHT-TO-LEFT CAROTID-TO-CAROTID BYPASS AND LEFT CAROTID-TO-SUBCLAVIAN BYPASS. ON (B)(6) 2014 (119 DAYS POST-PROCEDURE), AN ADDITIONAL STENT GRAFT WAS PLACED JUST DISTAL TO THE INNOMINATE ARTERY. NO INFORMATION IS AVAILABLE REGARDING THE DEVICE THAT WAS PLACED DURING THE SECONDARY INTERVENTION. THE SECONDARY INTERVENTION WAS DEEMED SUCCESSFUL WITH A RESULTING TYPE 2 ENDOLEAK. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED FOR THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422132 ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE E3004914

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Life Threatening| R