BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT MAIN BODY EXTENSION

    MDR report key: 1920562 · Received December 10, 2010

    Report

    Report Number
    1820334-2010-00641
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 8, 2010
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO PRODUCT OR IMAGES WERE PROVIDED TO ASSIST IN THIS 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 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, THE IMPORTANCE OF AN ACCURATE DEPLOYMENT. THE DEVICE WAS DEPLOYED INACCURATELY DUE TO THE REVERSE TAPER OF THE PROXIMAL AORTIC NECK AND OVERSIZING. THE COOK INCORPORATED SALES REPRESENTATIVE INDICATED THAT THE ISSUE WAS NOT RELATED TO TOP CAP RELEASE. PER COOK INCORPORATED CLINICAL EVALUATION, "OFF-LABEL USE SECONDARY TO ANATOMY OF LANDING ZONE, RESULTING IN A TYPE 1A ENDOLEAK WHICH COULD NOT BE CORRECTED ENDOVASCULARLY." THE EVENT WILL BE TRENDED AS CRITICAL HARM AS THE COMPLAINT INFO INDICATED THAT THE PT WOULD BE SCHEDULED FOR OPEN REPAIR. 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) AND 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 FEMALE PT UNDERWENT AN ABDOMINAL AORTIC ANEURYSM REPAIR ON (B)(6) 2010. THE PHYSICIAN PLACED A ZT FLEX MAIN BODY IN THE REVERSE TAPERED NECK AND DEPLOYED AT THE RENALS. AT THE TIME OF RELEASING THE TOPCAP, THE GRAFT SLIPPED DISTALLY ABOUT 5MM ALLOWING A TYPE 1 ENDOLEAK. THE LEGS WERE DEPLOYED AND BALLOONED. AN ATTEMPT WAS MADE TO PLACE A MAIN BODY EXTENSION PROXIMATELY AT THE RENALS. THE FIRST STENT OF THE MAIN BODY EXTENSION WAS AT THE RENALS UNTIL THE DISTAL END OF THE FIRST STENT WAS EXPOSED, IT THEN FOLDED OVER, DROPPING DOWN WELL BELOW THE ORIGINAL MAINBODY AND THEN FULLY OPENED AFTER THE DISTAL STENT DEPLOYED. ANOTHER MFR'S GRAFT WAS INSERTED AND IT TOO MIGRATED WHICH LEFT THE PT WITH A TYPE 1 ENDOLEAK. THE PT WILL RETURN TO THE OPERATING ROOM AFTER CARDIAC CLEARANCE FOR CHEST PAIN TO EXPLANT THE DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT MAIN BODY EXTENSION MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA 2428560

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other