BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH RENU AAA ANCILLARY GRAFT MAIN BODY EXTENSION

    MDR report key: 1790143 · Received August 3, 2010

    Report

    Report Number
    1820334-2010-00377
    Event Type
    Injury
    Date Received
    August 3, 2010
    Date of Event
    April 6, 2009
    Report Date
    July 12, 2010
    Manufacturer
    COOK INC
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): ADDITIONAL SURGICAL PROCEDURE. ENDOLEAKS AND MIGRATION IS ADDRESSED PER THE PROVIDED IFU. NO PRODUCT OR IMAGES WERE RETURNED TO ASSIST IN THE INVESTIGATION. NUMEROUS DESIGN VERIFICATION AND VALIDATION ACTIVITIES HAVE BEEN PERFORMED TO ENSURE THAT THIS DEVICE HAS THE PROPER REQUIREMENTS, AND THAT THE DEVICE MEETS THE NEEDS OF THE USER. IN ADDITION THE IFU'S FOR THE ZENITH LINE OF PRODUCTS LISTS SEVERAL KEY POINTS THAT COULD ELIMINATE THIS FAILURE MODE FROM OCCURRING: ANATOMICAL CRITERIA, PATIENT SIZING, PROPER AMOUNT OF OVERLAP BETWEEN COMPONENTS, PATIENT FOLLOW-UP GUIDELINES, ETC. THE COMPLAINT DEVICE WAS USED IN SECONDARY INTERVENTION TO REPAIR A MIGRATED STENT OF ANOTHER MANUFACTURER. THE PATIENT WAS TREATED 33 MONTHS POST-RENU IMPLANT BECAUSE OF COMPONENT SEPARATION BETWEEN THE RENU GRAFT AND PRE-EXISTING GRAFT. THE DISCONNECT OCCURRED TOO, BECAUSE OF CONTINUED MIGRATION OF THE PRE-EXISTING GRAFT. CORE LAB REVIEW INDICATED THAT THE AORTA HAD ELONGATED. IT IS POSSIBLE THAT ANATOMICAL CHANGES OVER TIME CONTRIBUTED TO THE CONTINUED MIGRATION. THE IFU STATES THE RENU GRAFT "IS DESIGNED TO PROVIDE POSITIVE PROXIMAL FIXATION BUT MAY NOT ADDRESS DEFICIENCIES IN PREVIOUSLY IMPLANTED ENDOVASCULAR GRAFTS OR CORRECT THE CLINICAL PROBLEM CAUSED BY THE PRE-EXISTING GRAFT." THERE IS NO INDICATION THAT THE PROXIMAL SEALING STENT MOVED RELATIVE TO THE ANATOMICAL LANDMARK. IT IS RECOMMENDED THAT THERE IS AT LEAST ONE Z STENT OVERLAP BETWEEN RENU EXTENSION AND PRE-EXISTING GRAFT. WE WILL NOTIFY THE APPROPRIATE INTERNAL PERSONNEL OF THE EVENT TO MONITOR FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT UNDERWENT IMPLANTATION OF A RENU CUFF AS TREATMENT FOR CAUDAL MIGRATION, PROXIMAL TYPE I ENDOLEAK, AND KINK OF A PRE-EXISTING AORTIC GRAFT OF ANOTHER MANUFACTURER'S ON (B)(6) 2006. ON A FOLLOW-UP CT EXAMINATION, APPROXIMATELY 32 MONTHS POST-RENU IMPLANT, THE ANEURYSM WAS NOTED TO HAVE EXPANDED BY 5 MM. A TYPE III ENDOLEAK WAS ALSO IDENTIFIED AS A RESULT OF CONTINUED MIGRATION OF THE PRE-EXISTING GRAFT. THE PATIENT UNDERWENT A SECONDARY INTERVENTION 33 MONTHS POST-RENU IMPLANT ON (B)(6) 2009 WITH PLACEMENT OF A RENU CONVERTER, A RIGHT ILIAC EXTENSION LIMB AND OCCLUSION OF THE LEFT ILIAC LIMB WITH AN ILIAC PLUG. A RIGHT-TO-LEFT FEMORAL-FEMORAL BYPASS WAS THEN PERFORMED. UPDATE RECEIVED ON 07/12/2010: THE ABOVE INFORMATION WAS INITIALLY REPORTED ON MAY 3, 2010. CORE LAB ANALYSIS OF THE 32-MONTH CT SCAN WAS RECEIVED ON 07/12/2010 AND INDICATED THAT THERE WAS COMPONENT SEPARATION OF BOTH THE RENU GRAFT AND THE PRE-EXISTING GRAFT. THE REVIEWER NOTED THAT IT "APPEARED THE AORTA HAS ELONGATED". PATIENT OUTCOME IS UNKNOWN AS NOT PROVIDED BY REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH RENU AAA ANCILLARY GRAFT MAIN BODY EXTENSION MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK INC NA 1549990

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention