BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH TX2 TAA ENDOVASCULAR GRAFT DISTAL COMPONENT

    MDR report key: 6039083 · Received October 19, 2016

    Report

    Report Number
    3002808486-2016-01257
    Event Type
    Injury
    Date Received
    October 19, 2016
    Date of Event
    October 11, 2016
    Report Date
    October 11, 2016
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002526638
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE SIMILAR TO DEVICE UNDER 510(K): P070016. INVESTIGATION IS STILL IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE SIMILAR TO DEVICE UNDER 510(K): P070016. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: BASED ON THIS INFORMATION PROVIDED IN THIS TW COMPLAINT FILE AS WELL AS THE IFU AND WO, IT WAS POSSIBLE TO CONCLUDE THAT THE ILIAC RUPTURE REPORTED MOST LIKELY WAS A CONSEQUENCE OF INADEQUATE PRE PROCEDURE EVALUATION OF VESSEL SIZE, ANATOMY AND DISEASE STATE. THE INTRODUCTION SYSTEM OF THE REPORTED DEVICE IS 20 FR. / 7.7 MM IN OUTER DIAMETER WHILE THE INTRODUCTION VESSEL, THE RIGHT CIA, WAS REPORTED TO BE 5.5 MM IN DIAMETER AND OBSERVED CALCIFIED ENTIRE CIRCUMFERENCE AS WELL. AS PER IFU CAREFUL EVALUATION OF VESSEL SIZE, ANATOMY AND DISEASE STATE IS REQUIRED TO ASSURE SUCCESSFUL SHEATH INTRODUCTION. ADVANCEMENT OF THE INTRODUCTION SYSTEM SHOULD NOT BE CONTINUED IF RESISTANCE IS FELT. PARTICULAR CARE SHOULD BE EXERCISED IN AREAS OF CALCIFIED VESSELS. IN THIS CASE FORCEFUL DEVICE ADVANCEMENT WAS ATTEMPTED. ILIO-FEMORAL VESSEL RUPTURE IS A KNOWN POTENTIAL ADVERSE EVENT. NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATION. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: A (B)(6) FEMALE PATIENT UNDERWENT TEVAR TREATMENT TO TREAT TAA. THE PATIENT'S ANATOMICAL FORM WERE SUITABLE FOR THE PROCEDURE. THE DEVICE WAS ADVANCED FROM RIGHT, AND THERE WAS OBSERVED CALCIFIED ENTIRE CIRCUMFERENCE AT RIGHT CIA (INNER DIAMETER OF RIGHT CIA WAS 5.5MM). THERE WAS ALSO OBSERVED CALCIFIED ENTIRE CIRCUMFERENCE AT LEFT EIA (INNER DIAMETER WAS 4MM). SO, RIGHT CIA WAS PRE DILATED WITH A PTA BALLOON (8MM), THEN A INTRODUCER SHEATH (GORE/DRYSEAL 20FR) WAS ADVANCED. ZTEG-2D-30-207-PF WAS OPENED AND ATTEMPTED TO ADVANCE, HOWEVER, IT WOULD NOT BE PASSED THROUGH. THE ILIAC ARTERY GOT RUPTURED DUE TO THE DEVICE ADVANCEMENT WITH FORCE. PATIENT OUTCOME: UNKNOWN AS INFORMATION WAS NOT PROVIDED.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: A (B)(6) FEMALE PATIENT UNDERWENT TEVAR TREATMENT TO TREAT TAA. THE PATIENT'S ANATOMICAL FORM WERE SUITABLE FOR THE PROCEDURE. THE DEVICE WAS ADVANCED FROM RIGHT, AND THERE WAS OBSERVED CALCIFIED ENTIRE CIRCUMFERENCE AT RIGHT CIA (INNER DIAMETER OF RIGHT CIA WAS 5.5MM). THERE WAS ALSO OBSERVED CALCIFIED ENTIRE CIRCUMFERENCE AT LEFT EIA (INNER DIAMETER WAS 4MM). SO, RIGHT CIA WAS PRE DILATED WITH A PTA BALLOON (8MM), THEN A INTRODUCER SHEATH (GORE/DRYSEAL 20FR) WAS ADVANCED. ZTEG-2D-30-207-PF WAS OPENED AND ATTEMPTED TO ADVANCE, HOWEVER, IT WOULD NOT BE PASSED THROUGH. THE ILIAC ARTERY GOT RUPTURED DUE TO THE DEVICE ADVANCEMENT WITH FORCE. PATIENT OUTCOME: UNKNOWN AS INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693745 ZENITH TX2 TAA ENDOVASCULAR GRAFT DISTAL COMPONENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE 10827002526638

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Life Threatening