BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 1931544 · Received December 10, 2010

    Report

    Report Number
    1820334-2010-00625
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 9, 2010
    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

    (B)(4). NO PRODUCT OR IMAGES WERE 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. SPECIFICALLY, THE IFU STATES, THE DEVICE IS INTENDED FOR PATIENTS THAT HAVE A NON-ANEURYSMAL NECK WITH AN ANGLE LESS THAN 60 DEGREES RELATIVE TO THE LONG AXIS OF THE ANEURYSM. THE DEVICE WAS USED OFF-LABEL BECAUSE OF ANATOMICAL EXCLUSION. PATIENT ANATOMY CONTRIBUTED TO A TYPE 1A ENDOLEAK. THE IFU WARNS THAT SEVERE NECK ANGULATION (>60 DEGREES BETWEEN NECK AND AXIS OF AAA) MAY AFFECT SUCCESSFUL EXCLUSION OF THE ANEURYSM. THE ENDOLEAK WAS RESOLVED AFTER PLACEMENT OF A ZENITH MAIN BODY EXTENSION AND ANOTHER MANUFACTURER'S STENT. A SUSPECTED TYPE 3A ENDOLEAK WAS RESOLVED AFTER BALLOONING. AT THIS TIME, THERE IS NO INDICATION THAT A DESIGN OR PROCESS INDUCED FAILURE OF THE DEVICE RESULTED IN THE REPORTED ENDOLEAKS. 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 (B)(6) MALE PATIENT UNDERWENT AAA REPAIR ON (B)(6) 2010. THE PROXIMAL NECK ANGLE WAS APPROXIMATELY 90 DEGREES RELATIVE TO THE LONG AXIS OF THE ANEURYSM. THE PROCEDURE WAS CONDUCTED AS LABELED AND THE FINAL ANGIOGRAPHY CONFIRMED A PROXIMAL TYPE I ENDOLEAK. A MAINBODY EXTENSION WAS ADDITIONALLY PLACED FOR THE PROXIMAL TYPE I ENDOLEAK, BUT IT WAS NOT SOLVED. THE LEAK WAS COMPLETELY SOLVED BY PLACING ANOTHER MANUFACTURER'S STENT. THEN A TYPE III ENDOLEAK FROM A JUNCTION PART WAS CONFIRMED, BUT IT WAS SOLVED BY PERFORMING KISSING BALLOON TECHNIQUE. THE PATIENT IS DOING FINE.

    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 F2537567

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention