BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 1791018 · Received July 30, 2010

    Report

    Report Number
    1820334-2010-00352
    Event Type
    Malfunction
    Date Received
    July 30, 2010
    Date of Event
    July 5, 2010
    Report Date
    July 6, 2010
    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

    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. SPECIFICALLY, THE IFU STATES THAT THE DEVICE IS INTENDED FOR PATIENTS HAVING A NON-ANEURYSMAL AORTIC NECK WITH A LENGTH OF AT LEAST 15MM. THE IFU ALSO STATES "KEY ANATOMIC ELEMENTS THAT MAY AFFECT SUCCESSFUL EXCLUSION OF THE ANEURYSM INCLUDE... AN INVERTED FUNNEL SHAPE (GREATER THAN 10% INCREASE IN DIAMETER OF 15MM OR PROXIMAL AORTIC NECK LENGTH)." THE PHYSICIAN COMMENTED THAT THE PT WAS NOT SUITABLE FOR EVAR AS THE PROXIMAL NECK WAS SHORT (10MM) AND INVERTED (24MM TO 27MM). THE PATIENTS ANATOMY LIKELY CONTRIBUTED TO THE REPORTED ENDOLEAK AS THE PROXIMAL SEAL WAS INSUFFICIENT. THE PHYSICIAN DID TAKE ADD'L ACTION AS IT WAS BELIEVED THAT ENDOLEAK WOULD BE RESOLVED AFTER HEPARIN NEUTRALIZATION. AT THIS TIME, THERE IS NO INDICATION THAT A DESIGN OR PROCESS INCLUDED FAILURE OF THE DEVICE RESULTED IN THE ENDOLEAK. AS WITH ALL ENDOLEAKS, IT IS IMPORTANT THAT THE TREATING PHYSICIAN FOLLOW THE PT'S ENDOLEAK APPROPRIATELY, AND PROVIDE FURTHER TREATMENT IF THE PHYSICIAN FEELS THE PT IS AT RISK OF ONGOING SAC PRESSURIZATION, ANEURYSM GROWTH, AND POSSIBLE RUPTURE. WE WILL NOTIFY THE APPROPRIATE INTERNAL PERSONNEL OF THE EVENT AND CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PT UNDERWENT EVAR WITH GENERAL ANESTHESIA ON (B)(6) 2010. THE PT'S ANATOMY WAS NOT SUITABLE FOR ENDOVASCULAR REPAIR SINCE THE PROXIMAL NECK WAS AN INVERTED FUNNEL SHAPE (THE DIAMETER OF THE PROXIMAL NECK INCREASE FROM 24MM TO 27MM), AND THE LENGTH OF THE PROXIMAL NECK WAS 10MM. MOREOVER, THE DIAMETER OF THE ACCESS VESSEL WAS 7MM. FINAL ANGIOGRAPHY REVEALED A PROXIMAL TYPE I ENDOLEAK. BALLOONING WAS PERFORMED TO RESOLVE THE ENDOLEAK. THE PROCEDURE WAS COMPLETED SINCE THE ENDOLEAK WAS REMAINED, BUT IT WAS REDUCED. THE PT'S CONDITION AFTER THE PROCEDURE IS UNK AS NOT PROVIDED BY THE REPORTER.

    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 F2416879

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR