BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL COMPONENT

    MDR report key: 6338538 · Received February 17, 2017

    Report

    Report Number
    3002808486-2017-00514
    Event Type
    Injury
    Date Received
    February 17, 2017
    Date of Event
    February 24, 2014
    Report Date
    February 24, 2014
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002527024
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SIMILAR TO DEVICE UNDER 510(K) P070060. SUMMARY OF INVESTIGATIONAL FINDINGS: BASED ON THE INVESTIGATION IT WAS CONSIDERED MOST LIKELY THAT THE DESCRIBED FRAYING OF THE SYSTEM WAS ATTRIBUTABLE TO THE ATTEMPT TO ADVANCE THE SYSTEM REPEATEDLY THROUGH A SEVERELY CALCIFIED VASCULATURE. NO EVIDENCE TO SUGGEST 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: ZTEG-2P-42-162-P WAS USED URGENTLY TO TREAT IMPENDING RUPTURE OF THE DESCENDING AORTA ANEURYSM. THERE WERE SEVERE CALCIFICATION IN BOTH RIGHT AND LEFT ACCESS ROUTES, FROM THE FA TO THE IA. HOWEVER, THE PHYSICIAN JUDGED THAT THE PATIENT WAS SUITABLE FOR THE REPAIR. THE DELIVERY SYSTEM WAS ADVANCED FROM THE RIGHT FA, BUT SEVERE CALCIFICATION PREVENTED ADVANCEMENT OF THE DEVICE. THE ACCESS ROUTE WAS DILATED WITH DRYSEAL SHEATH 18FR (BY GORE) TO MAKE A SECOND ATTEMPT OF ADVANCEMENT, BUT IT FAILED. DILATION WITH 9 MM PTA BALLOON (BY J & J) WAS PERFORMED TO MAKE A THIRD ATTEMPT OF ADVANCEMENT, BUT THE DELIVERY SYSTEM WOULD NOT ADVANCE THIS TIME EITHER. THEN, ACCESS POINT WAS CHANGED FROM RIGHT TO LEFT, INSERTING THE DELIVERY SYSTEM FROM THE LEFT GROIN. THE ACCESS ROUTE IN THE LEFT SIDE WAS ALSO DILATED WITH DRYSEAL SHEATH 18FR (BY GORE) BUT THE DELIVERY SYSTEM WOULD NOT ADVANCE, THEN DILATION WITH 9 MM PTA BALLOON (BY J & J) WAS PERFORMED TOO, BUT IT WOULD NOT ADVANCE THIS TIME EITHER. DUE TO THESE ATTEMPTS OF ADVANCEMENT, TIP OF THE DELIVERY SYSTEM GOT FRAYED. THE PHYSICIAN STOPPED USING THE DEVICE. SHORTER DEVICE (ZTEG-2P-42-135-PF) WAS SELECTED FOR THE NEXT TRY. DILATION OF THE LEFT ACCESS ROUTE SUCCEEDED WITH 9 MM PTA BALLOON (BY J & J), THEN THE DELIVERY SYSTEM OF THE REPLACING DEVICE COULD ADVANCE AND THE STENT GRAFT THAT WAS SHORTER THAN PLANNED WAS IMPLANTED. EXTENSION (TBE-42-81-PF) WAS ADDITIONALLY IMPLANTED TO MAKE UP THE UNCOVERED SITE WITH THE SHORTER STENT GRAFT. CONFIRMING THAT BOTH LEFT AND RIGHT ACCESS ROUTES WERE NOT DAMAGED BY THE ADDITIONAL TREATMENT, THE PROCEDURE WAS COMPLETED SUCCESSFULLY. USED TWO STENT GRAFTS WERE IMPLANTED IN THE TARGET SITE. PATIENT OUTCOME: THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121478 ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL COMPONENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE 10827002527024

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention