BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT

    MDR report key: 5976152 · Received September 26, 2016

    Report

    Report Number
    3002808486-2016-01117
    Event Type
    Death
    Date Received
    September 26, 2016
    Report Date
    August 30, 2016
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002443188
    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. (B)(4). INVESTIGATION IS STILL IN PROGRESS.

    Additional Manufacturer Narrative · 1

    DUE TO THE ADDITIONAL INFORMATION RECEIVED THE PATIENT DIED OF SEPTICEMIA CAUSED BY CELLULITIS AND AORTIC ANEURYSM INFECTION WHICH SUGGEST THAT OUR DEVICE DID NOT CAUSE OR CONTRIBUTED TO THE DEATH. THEREFORE THIS EVENT IS NOW CONSIDERED NOT REPORTABLE ACCORDING TO MEDICAL DEVICE REPORTING 21 CFR PART 803. MANUFACTURER REF# (B)(4). SIMILAR TO DEVICE UNDER 510(K) P070016. (B)(4). INVESTIGATION IS STILL IN PROGRESS

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: ON (B)(6) 2015: A (B)(6) MALE PATIENT UNDERWENT TEVAR TO TREAT AORTIC DISSECTION OF CHRONIC PHASE. ZTEG-2PT-32-160-PF-D ((B)(4)) WAS USED FOR THE PROCEDURE. ON (B)(6) 2015: ONE MONTH FOLLOW UP CONTRAST ENHANCED CT WAS PERFORMED. ON (B)(6) 2016: RECEIVED THE INFORMATION OF THE PATIENT'S DEATH (THE PATIENT DIED EARLY (B)(6) 2015). AUTOPSY WAS NOT PERFORMED. THE PATIENT HAD APPEALED CHEST PAIN; HOWEVER, DETAILS UNKNOWN. PATIENT OUTCOME: THE PATIENT DIED EARLY (B)(6) 2015.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: ON (B)(6) 2015: A (B)(6) MALE PATIENT UNDERWENT TEVAR TO TREAT AORTIC DISSECTION OF CHRONIC PHASE. ZTEG-2PT-32-160-PF-D (E3336459) WAS USED FOR THE PROCEDURE. ON (B)(6) 2015: ONE MONTH FOLLOW UP CONTRAST ENHANCED CT WAS PERFORMED. ON (B)(6) 2016: RECEIVED THE INFORMATION OF THE PATIENT'S DEATH (THE PATIENT DIED EARLY (B)(6) 2015). AUTOPSY WAS NOT PERFORMED. THE PATIENT HAD APPEALED CHEST PAIN; HOWEVER, DETAILS UNKNOWN. ADDITIONAL INFORMATION RECEIVED: ON (B)(6) 2015: CELLULITIS WAS OBSERVED, AND ANTIBIOTICS WERE ADMINISTERED. (IT WAS REPORTED AS IT WAS NOT RELATED WITH THE DEVICE.) ON (B)(6) 2015: SEPTICEMIA WAS OBSERVED, AND ANTIBIOTICS WERE ADMINISTERED. (IT WAS REPORTED AS IT WAS NOT RELATED WITH THE DEVICE.) ON (B)(6) 2015: THE PATIENT DIED DUE TO SEPTICEMIA CAUSED BY CELLULITIS AND AORTIC ANEURYSM INFECTION. PATIENT OUTCOME: THE PATIENT DIED ON (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629712 ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE 10827002443188

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death