BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 2091065 · Received May 12, 2011

    Report

    Report Number
    1820334-2011-00230
    Event Type
    Malfunction
    Date Received
    May 12, 2011
    Date of Event
    April 11, 2011
    Report Date
    April 12, 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 INFORMATION WAS PROVIDED REGARDING PATIENT OUTCOME/CONDITION. ENDOLEAKS ARE ADDRESSED IN THE PROVIDED IFU. NO PRODUCT BUT ONE STILL IMAGE WAS 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 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. BASED ON THE INFORMATION PROVIDED, THE PATIENT'S ANATOMY WAS SUITABLE FOR EVAR. A MAIN BODY EXTENSION WAS PLACED TO RESOLVE A TYPE IA. THE PHYSICIAN THEN DETERMINED THAT A TYPE IV ENDOLEAK WAS PRESENT AND DECIDED TO TAKE A WAIT-AND-SEE APPROACH. REVIEW OF THE ONE IMAGE THAT WAS RETURNED WAS INCONCLUSIVE. CONTRAST IS SEEN INSIDE THE MAIN BODY GRAFT WITH BLUSHING IN THE ANEURYSM SAC AND COLLATERALS. THE FULL ANGIOGRAPHIC RUN WOULD BE NEEDED TO ASSESS THE ETIOLOGY OF THE REPORTED ENDOLEAKS. EXCESSIVE ANTICOAGULATION DURING THE CASE MAY HAVE CONTRIBUTED TO THE REPORTED ENDOLEAK. IT IS REASONABLE TO SUGGEST THAT A TYPE 4 ENDOLEAK WILL RESOLVE SPONTANEOUSLY, ESPECIALLY AFTER HEPARIN NEUTRALIZATION, BASED ON PREVIOUS COMPLAINTS AND CLINICAL REVIEW. 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). 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 PATIENT UNDERWENT AAA REPAIR ON (B)(6) 2011. THE PATIENT'S ANATOMICAL FORM WAS SUITABLE FOR THE ENDOVASCULAR REPAIR ALTHOUGH HIS PROXIMAL NECK PART HAD TORTUOSITY. THE PROCEDURE WAS CONDUCTED AS LABELED. THE CONFIRMATORY ANGIOGRAPHY SHOWED AN ENDOLEAK WHICH APPEARED TO BE PROXIMAL TYPE I. A MAIN BODY EXTENSION WAS PLACED TO RESOLVE IT, AND IT WAS REDUCED BUT REMAINED. ANOTHER ANGIOGRAPHY WAS TAKEN IN THE GRAFT, AND IT SHOWED THAT THE ENDOLEAK WAS OCCURRING FROM WHOLE DEVICES. THEN, THE PHYSICIAN JUDGED IT AS A TYPE IV ENDOLEAK AND DECIDED TO TAKE A WAIT-AND-SEE APPROACH. (ACT: 252). THERE HAS BEEN NO PATIENT OUTCOME PROVIDED BY THE REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA F2611703

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR