BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 2915495 · Received January 11, 2013

    Report

    Report Number
    1820334-2013-00030
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 14, 2012
    Report Date
    December 14, 2012
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG # - IT IS UNKNOWN WHICH ZENITH DEVICE IS CONTRIBUTING TO THE PATIENT'S PAIN. EXPIRATION - UNKNOWN AS EXACT PRODUCT IS UNKNOWN. SINGLE USE DEVICE: UNKNOWN AS NOT PROVIDED BY REPORTER. (B)(4). UNKNOWN AS EXACT PRODUCT UNKNOWN. EVENT EVALUATION: ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION OR IMAGES HAVE BEEN RECEIVED AS OF (B)(4) 2013. IT IS UNCLEAR AS TO WHICH ZENITH DEVICE WOULD BE A CONTRIBUTOR TO THE PATIENT'S ISSUES OR IF THEY ARE RELATED TO ZENITH DEVICES AT ALL. THIS EVENT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    THE PATIENT CALLED IN THIS COMPLAINT. THE PATIENT CALLED IN STATING HIS PHYSICIAN TOLD HIM, "THERE WAS LEAKING THROUGH THE GRAFT MATERIAL." THE CUSTOMER/PATIENT WAS INQUIRING IF THIS IS NORMAL AND WANTED TO DISCUSS THIS ISSUE WITH SOMEONE FROM COOK. IN ADDITION, THE CUSTOMER/PATIENT STATED HE WAS EXPERIENCING SOME CHEST PAIN, BUT COULD NOT BE SURE IF THIS PAIN WAS DUE TO HIS IMPLANTED DEVICES. EVENT DESCRIPTION: NEW INFORMATION RECEIVED FROM COOK AAA TRAINING SPECIALIST (B)(6) 2012: PATIENT WAS RECENTLY ADMITTED TO THE HOSPITAL AFTER HIS DAUGHTER NOTICED HE HAD ULCERS ON HIS FEET AND TOOK HIM TO THE WOUNDED CLINIC. AFTER TAKING HIS HISTORY THEY DECIDED TO DO A CT SCAN ON THE PATIENT WITH AND WITHOUT CONTRAST. THEY DISCOVERED HE HAD A 9CM AAA AND THEY DISCHARGED HIM THURSDAY OR FRIDAY. THE COOK AAA TRAINING SPECIALIST (CATS) SPOKE WITH THE PATIENT TO GET INFORMATION AND HE INFORMED THE CATS THAT HE WAS HAVING GROIN PAIN. CATS LEFT A MESSAGE FOR THE PHYSICIAN. CATS ALSO SPOKE WITH COOK'S AREA REPRESENTATIVE IN THE AREA. THE PHYSICIAN'S OFFICE NEVER RETURNED THE CALL. CATS SPOKE WITH THE PATIENT ON SUNDAY AND HE GAVE THE CATS PERMISSION TO TALK WITH HIS DAUGHTER AND SHE EXPLAINED THAT HER FATHER WAS HAVING GROIN AND NOW BUTTOCK PAIN. THE AREA REPRESENTATIVE WAS ABLE TO HELP GET THE INFORMATION TO THE IMPLANTING PHYSICIAN AND THE PATIENT HAS AN APPOINTMENT AT THE AREA HOSPITAL ON (B)(6) 2012 TO FOLLOW UP ON HIS ENDOGRAFT. THE PATIENT HAS NOT HAD ANY FOLLOW UP SINCE HE HAD HIS GRAFT IMPLANTED IN 2004. THE CATS WILL WORK ON GETTING THE IMAGING SO WE CAN FOLLOW UP ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19083 ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY MIH COOK, INC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other