BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL COMPONENT

    MDR report key: 6010550 · Received October 7, 2016

    Report

    Report Number
    3002808486-2016-01201
    Event Type
    Injury
    Date Received
    October 7, 2016
    Date of Event
    July 22, 2016
    Report Date
    September 16, 2016
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    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

    (B)(4). PMA 510(K): SIMILAR TO DEVICE UNDER 510(K) P070016. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: BASED ON THE IMAGING REVIEW IT WAS POSSIBLE TO CONFIRM THE PRESENCE OF TWO ENDOLEAKS CONSISTENT WITH TYPE 3 SUTURE HOLE ENDOLEAKS THROUGH THE DISTAL ASPECT OF THE MOST PROXIMAL GRAFT. THE CLINICAL SIGNIFICANCE OF THESE ENDOLEAKS IS DOUBTFUL DUE TO THE FACT THAT MAXIMAL AORTIC DIAMETER ADJACENT THE ENDOLEAKS DECREASED FROM 9.5CM TO 8.5CM BETWEEN SIX AND EIGHT MONTHS. THE PRESENCE OF A TYPE 2 ENDOLEAK WAS CONFIRMED IN THE ABDOMINAL AORTA, WHICH POSSIBLY CONTRIBUTED TO INCREASE OF THE ABDOMINAL AORTIC MAXIMAL DIAMETER. THE ORIGINAL PATHOLOGY WAS MUCH MORE LIKELY A TYPE A AND TYPE B CHRONIC AORTIC DISSECTION RATHER THAN ANEURYSMAL DISEASE AS STATED ABOVE. THE AORTA WAS CONTINUOUSLY DILATED IN THE MID THORACIC AORTA, THE DISTAL THORACIC AORTA, AND THE ABDOMINAL AORTA. THE GRAFTS WERE IMPLANTED IN A CHRONIC DISSECTION INVOLVING THE ENTIRE AORTA, SO THE THORACIC GRAFT COMPONENTS WERE IMPLANTED IN A CONTINUOUSLY DISEASED VESSEL OFFERING LESS STRUCTURAL SUPPORT AND GREATER MOTION THAT RECOMMENDED. AS PER IFU THE GRAFTS SHOULD BE POSITIONED WITH PROXIMAL AND DISTAL NECK LENGTH OF AT LEAST 20 MM HEALTHY AORTA. CONSEQUENTLY, THE GRAFT WAS SUBJECT TO GREATER REPETITIVE BUT LESS SUPPORTED MOTION. THIS WOULD INCREASE THE STRESS ON SUTURE HOLES, CONTRIBUTING TO THE DEVELOPMENT OF TYPE 3 ENDOLEAK. 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 · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: ON (B)(6) 2013: A (B)(6) FEMALE PATIENT UNDERWENT DTAA REPAIR WITH PLACING THREE OF ZTEG-2P-32-200-PF. REPLACEMENT OF THE ASCENDING AORTA, AND THORACIC AND ABDOMINAL BRANCH BYPASS WERE PERFORMED PREVIOUSLY. ON (B)(6) 2016: OBVIOUS BLOOD FLOW FROM THE GRAFT INTO THE ANEURYSM WAS CONFIRMED BY 4DCT IMAGE. TYPE III ENDOLEAK (GRAFT DAMAGE OR SUTURE HOLE) WAS SUSPECTED. ADDITIONAL PROCEDURE USING OTHER MANUFACTURER'S PRODUCT TO TREAT THE ENDOLEAK WILL BE PERFORMED AT THE END OF THIS YEAR. PATIENT OUTCOME: THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: ON (B)(6) 2013: A (B)(6) YEAR OLD FEMALE PATIENT UNDERWENT DTAA REPAIR WITH PLACING THREE OF ZTEG-2P-32-200-PF. REPLACEMENT OF THE ASCENDING AORTA, AND THORACIC AND ABDOMINAL BRANCH BYPASS WERE PERFORMED PREVIOUSLY. ON (B)(6) 2016: OBVIOUS BLOOD FLOW FROM THE GRAFT INTO THE ANEURYSM WAS CONFIRMED BY 4DCT IMAGE. TYPE III ENDOLEAK (GRAFT DAMAGE OR SUTURE HOLE) WAS SUSPECTED. ADDITIONAL PROCEDURE USING OTHER MANUFACTURER'S PRODUCT TO TREAT THE ENDOLEAK WILL BE PERFORMED AT THE END OF THIS YEAR. PATIENT OUTCOME: THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662524 ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL COMPONENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening