BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL COMPONENT

    MDR report key: 6331039 · Received February 15, 2017

    Report

    Report Number
    3002808486-2017-00419
    Event Type
    Injury
    Date Received
    February 15, 2017
    Date of Event
    March 28, 2013
    Report Date
    March 28, 2013
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002526836
    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). SUMMARY OF INVESTIGATIONAL FINDINGS: BASED ON THE AVAILABLE INFORMATION IT HAS NOT BEEN POSSIBLE TO CONCLUDE THE EXACT ROOT CAUSE FOR THIS EVENT. HOWEVER PATIENT CALCIFICATION/WEAK VESSEL CONDITION CAN BE THE CAUSE OF THE OBSERVED DISSECTIONS. NO EVIDENCE TO SUGGEST THAT PRODUCT WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. (B)(4). SIMILAR TO DEVICE UNDER 510(K) P070016. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: BASED ON THE AVAILABLE INFORMATION IT HAS NOT BEEN POSSIBLE TO CONCLUDE THE EXACT ROOT CAUSE FOR THIS EVENT. HOWEVER PATIENT CALCIFICATION/WEAK VESSEL CONDITION CAN BE THE CAUSE OF THE OBSERVED DISSECTIONS. 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: AN (B)(6) YEAR OLD FEMALE PATIENT UNDERWENT TEVAR REPAIR ON (B)(6) 2013. IT WAS AN OFF-LABEL USE SINCE THE PROCEDURE WAS CONDUCTED TO PREVENT ENDOLEAK FROM INTIMAL TEAR WHERE ANOTHER STENT GRAFT BEING ALTERED BY THE PHYSICIAN HAD ALREADY BEEN IMPLANTED BEFORE. CALCIFICATION COULD BE OBSERVED PARTIALLY IN THE ACCESS ROUTE THOUGH, THE PHYSICIAN JUDGED THAT THERE WAS NO ANATOMICAL PROBLEM TO CONDUCT THE PROCEDURE DUE TO NO PROBLEMATIC TORTUOSITY. AN ANGIO CATHETER WAS INSERTED FROM THE RIGHT FA, AND THE DELIVERY SYSTEM OF THE DEVICE WAS INSERTED FROM THE LEFT FA TO PLACE THE STENT GRAFT ABOVE CELIAC ARTERY IN THE DESCENDING AORTA. THE PHYSICIAN ENCOUNTERED SLIGHT RESISTANCE WHEN ADVANCING THE DELIVERY SYSTEM DESPITE NO CALCIFICATION OR SEVERE TORTUOSITY. ANGIOGRAPHY WAS PERFORMED IN THE ILIAC ARTERY AND IT CONFIRMED DISSECTIONS IN THE BIFURCATION AREA BETWEEN LEFT EIA & IIA AND THE DEVICE INSERTION POINT IN THE LEFT FA. FOR DISSECTION IN THE BIFURCATION AREA, A BARE STENT (DETAILS UNKNOWN) WAS PLACED IN THE BIFURCATION. FOR DISSECTION OF THE INSERTION POINT, THE VESSEL WAS EXPOSED TO STRIP OFF THE INTIMAL DISSECTION, THEN PATCHED WITH A VESSEL PROTHESIS. PATIENT OUTCOME: THERE HAS BEEN NO PATIENT OUTCOME REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113839 ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL COMPONENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE 10827002526836

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Life Threatening| R