BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG

    MDR report key: 2083137 · Received April 12, 2011

    Report

    Report Number
    1820334-2011-00184
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    March 18, 2011
    Report Date
    March 22, 2011
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PT OUTCOME INFO HAS BEEN PROVIDED BY THE REPORTER. ENDOLEAKS ARE LABELED IN THE IFU. NO PRODUCT IMAGES WERE RETURNED TO ASSIST IN THE INVESTIGATION AT THIS TIME. 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, F/U GUIDELINES. BY REPORT, THE PT WAS NOT SUITABLE FOR EVAR DUE TO ANATOMICAL EXCLUSION (ANEURYSM ILIAC). A TYPE IA AND IB ENDOLEAK WERE RESOLVED BY BALLOONING AND PLACEMENT OF AN ADDITIONAL ILIAC LEG, RESPECTIVELY. THE PHYSICIAN CONCLUDED THAT THE ENDOLEAK IN THE LEFT COMMON WAS A TYPE IV, BUT STATED THAT THE TYPE WAS UNCLEAR. PLACEMENT OF AN ADDITIONAL ILIAC LEG RESOLVED THE ENDOLEAK. ETIOLOGY OF THE ENDOLEAK IS UNK. AT THIS TIME, THERE IS NO INDICATION THAT A DESIGN OR PROCESS INDUCED FAILURE OF THE DEVICE RESULTED IN 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) 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) 2011. THE PT'S ANATOMICAL FORM WAS NOT SUITABLE FOR THE PROCEDURE. THE RIGHT CIA'S OUTER DIAMETER (OD) WAS 22MM. HOWEVER, THE PROCEDURE WAS CONDUCTED AS LABELED. THE FINAL CONFIRMATORY ANGIOGRAPHY SHOWED A PROXIMAL TYPE I ENDOLEAK FROM MAIN BODY AND A DISTAL TYPE I ENDOLEAK FROM THE RIGHT LEG. ALSO, AN UNIDENTIFIED ENDOLEAK WAS CONFIRMED FROM THE LEFT CIA. BALLOONING WAS PERFORMED WITH A CODA BALLOON FOR THE PROXIMAL TYPE I ENDOLEAK, AND AN ILIAC LEG GRAFT WAS ADDITIONALLY PLACED FOR THE DISTAL TYPE I ENDOLEAK. THEN, BOTH TYPE I ENDOLEAKS WERE GONE. THE UNIDENTIFIED ENDOLEAK FROM THE LEFT CIA WAS CONSIDERED AS A TYPE IV ENDOLEAK AND ANOTHER ILIAC LEG GRAFT WAS ADDITIONALLY PLACED. THEN, THE ENDOLEAK WAS SOLVED. (ACT:245). THERE HAS BEEN NO PT'S OUTCOME PROVIDED AFTER THE OPERATION AND NO IMAGES WILL BE PROVIDED TO ASSIST IN THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA F2604541

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR