BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 2132483 · Received June 8, 2011

    Report

    Report Number
    1820334-2011-00284
    Event Type
    Injury
    Date Received
    June 8, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 13, 2011
    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

    THE ZENITH DEVICE HAS COMPLETED DESIGN CONTROL REQUIREMENTS SHOWING THE DEVICE MEETS 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. PT ANATOMY (INVERTED FUNNEL SHAPE NECK/CALCIFICATION) LIKELY CONTRIBUTED TO THE REPORTED TYPE IA. PLACEMENT OF ANOTHER MFR'S STENT DID NOT RESOLVE. THE PHYSICIAN DECIDED TO TAKE A WAIT-AND-SEE APPROACH. 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).

    Description of Event or Problem · 1

    A PT UNDERWENT AAA REPAIR ON (B)(6) 2011. THE PT'S ANATOMICAL FORM WAS SUITABLE FOR THE PROCEDURE ALTHOUGH LANDING ZONE BELOW RENAL ARTERY WAS SLIGHTLY INVERTED FUNNEL SHAPE. NO DIFFICULTY OF MAIN BODY PLACEMENT AT PROXIMAL SITE WAS OBSERVED, HOWEVER, FINAL CONFIRMATORY ANGIOGRAPHY REVEALED PROXIMAL TYPE I ENDOLEAK. BALLOONING WITH A CODA BALLOON CATHETER WAS PERFORMED, BUT ENDOLEAK WAS NOT RESOLVED. EVEN AFTER ANOTHER MFR'S (PALMAZ) STENT WAS PLACED AT PROXIMAL SITE ENDOLEAK INTO ANEURYSM REMAINED. THE PHYSICIAN DECIDED TO TAKE F/U OBSERVATION. (DIAMETER OF PROXIMAL NECK WAS 25MM ACT WAS OVER 200). NO ADVERSE EFFECT TO THE PT WAS OBSERVED. THE PHYSICIAN THOUGHT THAT CALCIFICATION AT THE PROXIMAL SITE WAS THOUGHT TO CONTRIBUTE TO THE INADEQUATE SEALING.

    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 2642478

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention