BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH RENU AAA ANCILLARY GRAFT CONVERTER

    MDR report key: 2132484 · Received June 8, 2011

    Report

    Report Number
    1820334-2011-00280
    Event Type
    Injury
    Date Received
    June 8, 2011
    Date of Event
    May 3, 2011
    Report Date
    May 10, 2011
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ZENITH DEVICE HAS COMPLETED DESIGN CONTROL REQUIREMENTS SHOWING THE DEVICE MEETS THE PREDETERMINED REQUIREMENTS AND THAT THE REQUIREMENTS MEET THE NEEDS OF THE USER. EACH ZENITH DEVICE IS SHIPPED WITH INSTRUCTIONS FOR USE (IFU) LISTING THE INDICATIONS FOR USE, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, AND THE CORRECT DEPLOYMENT PROCEDURE. IN REGARDS TO ENDOLEAKS, THE IFU LISTS SEVERAL WARNINGS/PRECAUTIONS THAT, IF FOLLOWED, COULD PREVENT THIS FAILURE MODE FROM OCCURRING OR LESSEN THE ASSOCIATED EFFECTS; ANATOMICAL CRITERIA, ANATOMICAL CONDITIONS, PROPER BALLOONING SITES, FOLLOW-UP GUIDELINES. PER INFORMATION PROVIDED, DATE OF INITIAL REPAIR IS UNKNOWN. THE PATIENT WAS NOT AVAILABLE FOR THE RECOMMENDED FOLLOW-UP PER THE IFU. THE PATIENT PRESENTED WITH A TYPE III ENDOLEAK AND ANOTHER MANUFACTURER'S COVERED STENT WAS IMPLANTED TO RESOLVE. THE PATIENT TOLERATED THE PROCEDURE. WITHOUT IMAGING OR ADDITIONAL INFORMATION IT IS DIFFICULT TO DETERMINE A ROOT CAUSE OR CONTRIBUTING FACTORS OF THE REPORTED ENDOLEAK. WE WILL NOTIFY THE APPROPRIATE INTERNAL PERSONNEL OF THE EVENT AND CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THE RISK ASSOCIATED WITH THIS FAILURE MODE WAS EVALUATED PER QUALITY ENGINEERING RISK ASSESSMENT (QERA).

    Description of Event or Problem · 1

    A (B)(6) OLD MALE UNDERWENT AN ABDOMINAL AORTIC ANEURYSM REPAIR FOR AN 11 CM RUPTURE. THE PATIENT WAS LOST FOR FOLLOW UP. THE PATIENT RETURNED TO THE HOSPITAL WITH A TYPE 3 ENDOLEAK AND 10 CM SYMPTOMATIC AAA. THE PHYSICIAN RELINED THE ILIAC LIMB WITH ANOTHER MANUFACTURER'S ENDOPROSTHESIS. NO ZENITH PRODUCTS WERE PLACED DURING THIS PROCEDURE. THE PROCEDURE WAS SUCCESSFUL. NO IMAGES ARE AVAILABLE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH RENU AAA ANCILLARY GRAFT CONVERTER MIH COOK, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention