BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL COMPONENT

    MDR report key: 6982735 · Received October 27, 2017

    Report

    Report Number
    3002808486-2017-02145
    Event Type
    Injury
    Date Received
    October 27, 2017
    Date of Event
    October 6, 2017
    Report Date
    January 12, 2018
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002526867
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURERS REF# (B)(4). SIMILAR TO DEVICE UNDER 510(K) P070016. G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113 G5) SIMILAR TO DEVICE UNDER 510(K) P070016. (B)(4). INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: A (B)(6) MALE PATIENT WHO PREVIOUSLY RECEIVED OPEN REPAIR WITH Y-SHAPED GRAFT IN ABDOMINAL LESION (PROXIMAL 16 MM, DISTAL 9 MM) UNDERWENT TAA REPAIR. THE PATIENT'S ANATOMY WAS SUITABLE FOR TEVAR. THERE WAS SEEN SEVERE TORTUOUSLY ON THE PATIENT¿S RIGHT ARTIFICIAL GRAFT. ON THE LEFT SIDE, IT WAS ENOUGH INNER DIAMETER (8 MM) TO PASS THE DELIVERY SYSTEM, THEREFORE ACCESS WAS GAINED FROM THE LEFT. ZTEG-2P-32-200-PF ((B)(4)) WAS ADVANCED AS PLANNED FROM THE LEFT, HOWEVER, THE DELIVERY SYSTEM WOULD NOT ADVANCE AT TORTUOUS LESION IN THE MIDDLE OF ARTIFICIAL VESSEL. THE PHYSICIAN ATTEMPTED TO ADVANCE THE DELIVERY SYSTEM SEVERAL TIMES, HOWEVER, UNDER THE FLUOROSCOPIC IMAGES, THE DELIVERY SYSTEM SEEMED IT SHAPED AS IT BENT BETWEEN THE ARTIFICIAL GRAFT AND ADVANCEMENT FORCE WOULD NOT TRANSMIT TO THE DELIVERY SYSTEM, SO THE DELIVERY SYSTEM WOULD NOT ADVANCE ANYMORE . THEN, ANOTHER DEVICE TBE-32-80-PF ((B)(4)) WAS TRIED TO PASS THROUGH THE ARTIFICIAL VESSEL TO STRAIGHTEN, HOWEVER THE SECOND DELIVERY SYSTEM WOULD NOT ADVANCE DUE TO THE SAME REASON OF THE FIRST DEVICE. SO, THE PHYSICIAN CONSIDERED TO USE ANOTHER MANUFACTURE'S DEVICE, BUT THERE IS A RISK OF DAMAGE OF ANASTOMOTIC REGION OF ARTIFICIAL GRAFT DUE TO OUTER SHEATH SIZE (BECAUSE OTHERS ARE LARGER THAN TX2), THE PHYSICIAN DISCONTINUED THE PROCEDURE. HE REPAIRED THE ACCESS SITE TO FINISH THE PROCEDURE. PATIENT OUTCOME: IT IS UNDER CONSIDERATION WHAT PROCEDURE WILL BE PERFORMED. THERE HAVE BEEN NO ADVERSE EFFECT TO THE PATIENT REPORTED.

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER E2016032. (B)(4). MANUFACTURER REF# (B)(4). (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: THIS COMPLAINT CONCERNS A PATIENT WITH TAA WHO PREVIOUSLY RECEIVED OPEN REPAIR WITH Y-SHAPED GRAFT IN AN ABDOMINAL LESION. THE DEVICE WAS ADVANCED IN THE LEFT ARTIFICIAL VESSEL WITH AN INNER DIAMETER OF 8 MM. HOWEVER, THE DELIVERY SYSTEM WOULD NOT ADVANCE THROUGH A TORTUOUS LESION IN THE MIDDLE OF ARTIFICIAL VESSEL. THE PHYSICIAN DISCONTINUED THE PROCEDURE. NO IMAGING OF PATIENT ANATOMY WAS PROVIDED, TO ASSESS VESSEL TORTUOSITY. HOWEVER, THE PHYSICIAN STATED THAT THE DEVICE LIKELY GOT CAUGHT IN THE TORTUOUS ARTIFICIAL VESSEL EVEN THOUGH THE DIAMETER WAS SUFFICIENT FOR THE INTRODUCTION SYSTEM. NO EVIDENCE TO SUGGEST THAT THE PRODUCT WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762978 ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL COMPONENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE 10827002526867

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Life Threatening