BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL COMPONENT

    MDR report key: 6338546 · Received February 17, 2017

    Report

    Report Number
    3002808486-2017-00511
    Event Type
    Malfunction
    Date Received
    February 17, 2017
    Date of Event
    December 11, 2012
    Report Date
    December 11, 2012
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002526997
    Product Problem
    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. SUMMARY OF INVESTIGATIONAL FINDINGS: AS NO PRODUCT, PHOTOS OR IMAGING RECEIVED TO SUPPORT THIS INVESTIGATION IT HAS NOT BEEN POSSIBLE TO CONCLUDE AN EXACT ROOT CAUSE FOR THIS EVENT. NOTHING INDICATES DEVICE FAILURE AND NO EVIDENCE WAS FOUND SUGGESTING THAT THE DEVICE WAS MANUFACTURED OUTSIDE OF SPECIFICATIONS. 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) MALE PATIENT UNDERWENT URGENT TAA REPAIR DUE TO RUPTURE OF AORTIC ARCH ANEURYSM. THE PATIENT'S AORTIC ARCH SHAPE WAS CLASSIFIED AS CRENEL GEOMETRY. THOUGH THERE WAS CALCIFICATION IN A PART OF THE ACCESS ROUTE, THE PHYSICIAN JUDGED THAT THE PATIENT WAS SUITABLE FOR ENDOVASCULAR REPAIR. THE DELIVERY SYSTEM WAS INSERTED FROM THE LEFT FEMORAL ARTERY TO PLACE THE STENT GRAFT UNDER THE ENTRANCE OF LEFT COMMON CAROTID ARTERY DUE TO OCCLUSION IN THE LEFT SUBCLAVIAN ARTERY. ANGIO CATHETER WAS INSERTED FROM THE RIGHT FEMORAL ARTERY. THE DELIVERY SYSTEM ADVANCED THROUGH THE ILIAC AND ABDOMINAL ARTERIES WITH NO PROBLEM, BUT IT BECAME UNABLE TO ADVANCE THROUGH THE AORTIC ARCH SINCE ANEURYSM WAS PROJECTED TOWARD THE GREATER CURVATURE OF THE ARCH. DESPITE MANIPULATION OF THE WIRE GUIDE, THE DELIVERY SYSTEM DID NOT ADVANCE TO THE LEFT SUBCLAVIAN ARTERY OR LEFT COMMON CAROTID ARTERY. THEN, THE PHYSICIAN STOPPED USING THE DEVICE AND ZTEG-2P-38-202-JP WAS USED INSTEAD. THE DEVICE WITH HARDER SHAFT COULD REACH TO THE DESIRED POSITION. PATIENT OUTCOME: THERE HAS BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121485 ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL COMPONENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE 10827002526997

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR