BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL COMPONENT

    MDR report key: 6313661 · Received February 9, 2017

    Report

    Report Number
    3002808486-2017-00375
    Event Type
    Death
    Date Received
    February 9, 2017
    Date of Event
    February 24, 2014
    Report Date
    February 24, 2014
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002526942
    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): P070016. SUMMARY OF INVESTIGATIONAL FINDINGS: THE INVESTIGATION OF THIS COMPLAINT WAS BASED ON THE REPORTED INFORMATION ALONG WITH ONE IMAGE OF A PORTABLE CHEST X-RAY. ACCORDING TO THE IMAGE, AN AORTIC RUPTURE WITH A LARGE HEMATOMA WAS EVIDENT AT THE TIME OF THIS X-RAY. IT IS HOWEVER NOT POSSIBLE TO DETERMINE THE CAUSE BASED ON ONE SINGLE LOW QUALITY IMAGE. NOTHING INDICATES THAT PRODUCT 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: AN (B)(6) YEAR OLD MALE PATIENT UNDERWENT TAA REPAIR. THE PATIENT'S ANATOMICAL FORM WAS SUITABLE FOR ENDOVASCULAR REPAIR. THE ACCESS VESSEL WAS THE RIGHT EXTERNAL ILIAC ARTERY AND ZTEG-2P-38-152-PF WAS PLACED FIRST AND ZTEG-2D-42-144-PF WAS PLACED NEXT AND THE PROCEDURE WAS COMPLETED. WHEN THE PATIENT WAS GOING BACK TO THE WARD AFTER COMING OUT FROM UNDER ANESTHESIA, HE COMPLAINED A CHEST PAIN. THEN THE BLOOD PRESSURE DECREASED TO 50 FROM 90, THEN HE WENT INTO CARDIAC ARREST. PCPS WAS USED WITH CARDIAC MASSAGE, HOWEVER THE PATIENT DECEASED. ADDITIONAL INFORMATION RECEIVED (B)(6) 2014: AN AUTOPSY WAS NOT CONDUCTED. A X-RAY IMAGE WAS PROVIDED. THE PHYSICIAN COMMENTED AS "THE CAUSE OF THE DISSECTION WAS REALLY UNKNOWN SINCE IT HAD NOT CONFIRMED DURING THE PROCEDURE AND THE CONDITION SUDDENLY CHANGED AFTER THE INCISION WAS CLOSED. ONLY POSSIBLE CAUSE OF THE COULD BE A TOUCH UP BY BALLOON, BUT IT OCCURRED TOO LATE FROM THE TOUCH UP." THE VESSEL CONDITION WAS NOT FRAGILE. ALTHOUGH IT WAS SLIGHTLY SHAGGY AND TORTUOUS, SO THE PHYSICIAN USED A WIRE GUIDE WITH CAUTION AND NO INJURY BY THE WIRE GUIDE WAS CONFIRMED. PATIENT OUTCOME: THE PATIENT DECEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100165 ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL COMPONENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE 10827002526942

    Patients

    Seq Age Sex Outcome Treatment
    1 81 Death