BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 3925637 · Received June 30, 2014

    Report

    Report Number
    1820334-2014-00299
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT EVAL: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    AS PER THE PROBLEM STATEMENT: THE CUSTOMER BELIEVES THERE MAY HAVE BEEN A GRAFT TEAR OR DISRUPTION IN THE STITCHING AS AFTER MANY INVESTIGATIONS THERE ARE NO OTHER TYPES OF LEAKS. ADD'L INFO PROVIDED (B)(6) 2014: A MALE PT WENT FOR A ROUTINE ANNUAL CHECK UP/ABDOMINAL SCAN (B)(6) 2014 POST EVAR WHICH SHOWED A GENERAL ENDOLEAK OF UNK ORIGIN. THE REP ATTENDED THE BOOKED CASE TODAY FOR THE RELINING OF AN OLD ZENITH. THEY BELIEVE IT MAY HAVE BEEN A GRAFT TEAR OR DISRUPTION IN THE STITCHING AS AFTER MANY INVESTIGATIONS THERE ARE NO OTHER TYPES OF LEAKS THE PHYSICIAN SAYS. IT IS A PT WITH A ZENITH IMPLANTED IN 2007 THAT THEY THINK THEY NEED TO RELINE DUE TO A PROBABLE OCCULT TYPE 3 ENDOLEAK. UPON SEEING THE IMAGING AT THE START OF THE PROCEDURE IT DID LOOK LIKE THE LEAK WAS COMING FROM THE GRAFT FABRIC IN THE MIDDLE OF THE FLEX MAIN BODY. THE TRUST WILL NOT PROVIDE ANY IMAGES AS THEY SPECIFICALLY STATED THEY DID NOT WANT TO PROCESS THIS AS A COMPLAINT. SECONDARY INTERVENTION WAS SUCCESSFUL AND THE "ENDOLEAK" WAS FIXED BY INSERTING A COOK RX1 GRAFT. THE ISSUES HAD CAUSED THE ANEURYSM SAC TO REFILL TO 8.5CM. THE CUSTOMER IS NOT SENDING BACK ANY UNUSED PRODUCT FROM THAT SAME LOT FOR INVESTIGATION. THEY ARE NOT PROVIDING PHOTOS, OPERATING REPORTS, X-RAYS OR SCANS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379817 ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA 1926478 TO BE CONFIRMED

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention