BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 1910377 · Received November 30, 2010

    Report

    Report Number
    1820334-2010-00595
    Event Type
    Injury
    Date Received
    November 30, 2010
    Date of Event
    October 21, 2010
    Report Date
    October 27, 2010
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO PRODUCT OR IMAGES WERE RETURNED TO ASSIST IN THE INVESTIGATION. 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 WARNING/PRECAUTIONS THAT, IF FOLLOWED, COULD PREVENT THIS FAILURE MODE FROM OCCURRING OR LESSEN THE ASSOCIATED EFFECTS; ANATOMICAL CRITERIA, ANATOMICAL CONDITIONS, PROPER BALLOONING SITES, F/U GUIDELINES, THE IMPORTANCE OF AN ACCURATE DEPLOYMENT. CAUSALITY AND CONTRIBUTING FACTORS CANNOT BE DETERMINED WITH THE INFO PROVIDED. PER COOK INC CLINICAL REVIEW, THE REPORTED EVENTS WERE LIKELY THE RESULT OF CONTINUED ANEURYSM GROWTH RELATED TO DISEASE PROGRESSION. CONTINUED ANEURYSM GROWTH LIKELY RESULTED IN THE REPORTED ENDOLEAKS AND SUBSEQUENT DEVICE MIGRATION. INACCURATE DEPLOYMENT DURING INITIAL REPAIR OR INTERVENTION MAY HAVE EXACERBATED THE REPORTED COMPLICATIONS. THE EVENT WILL BE TRENDED AS ENDOLEAK AS CAUSALITY IS UNCERTAIN AT THIS TIME. WE WILL NOTIFY THE 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). THE RISK ASSOCIATED WITH THE FAILURE MODE WILL REMAIN AT AN ACCEPTABLE LEVEL WITH INCLUSION OF THE EVENT. RISK MITIGATION IS NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    A (B)(6) MALE PT UNDERWENT AAA REPAIR ON (B)(6) 2009. F/U ON (B)(6) 2010: THE PHYSICIAN DID ANGIOGRAPHY AND RECOGNIZED THE PROXIMAL TYPE I ENDOLEAK AND TYPE III ENDOLEAK (1820334-2010-00596) AT THE JUNCTION PORTION OF THE CONTRALATERAL LEG. (THERE IS A POSSIBILITY THAT THE IPSILATERAL LEG MIGRATION). ADDITIONAL PROCEDURE ON (B)(6)2010: FOR THE TYPE I ENDOLEAK. THE PHYSICIAN PLACED A MAIN BODY EXTENSION JUST BELOW THE RENAL ARTERY. ALSO PLACED ANOTHER MFR'S XL STENT FROM THE PROXIMAL SIDE OF THE RENAL ARTERY AND STRIDE OVER IT THE MAIN BODY EXTENSION, ANOTHER XL STENT WAS PLACED AT THE DISTAL SIDE. FOR THE TYPE III ENDOLEAK, THERE IS A POSSIBILITY THAT THERE IS THE TYPE I ENDOLEAK AT THE DISTAL NECK, SO THE PHYSICIAN EMBOLIZED THE LEFT INTERNAL ILIAC ARTERY AND PLACED A ZT ILIAC LEG GRAFT FROM THE CONTRALATERAL LIMB TO EXTERNAL ILIAC ARTERY. ALSO PLACED ANOTHER MFR'S (10MMX27MM) AT THE JUNCTION PORTION OF THE CONTRALATERAL LEG. THE TYPE I AND TYPE III ENDOLEAK WERE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA F2366789

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention