BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 1901474 · Received November 12, 2010

    Report

    Report Number
    1820334-2010-00570
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    October 8, 2010
    Report Date
    October 14, 2010
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO PRODUCT OR IMAGES WERE PROVIDED TO ASSIST IN THIS 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, THE IMPORTANCE OF AN ACCURATE DEPLOYMENT. IN REGARDS TO THIS EVENT, THE IFU STATES THAT THE DEVICE IS INDICATED FOR PTS WITH AN INFRARENAL AORTIC NECK SEGMENT AT LEAST 15MM IN LENGTH. THE PT'S SHORT PROXIMAL NECK LIKELY CONTRIBUTED TO THE REPORTED ENDOLEAK. AT THIS TIME, THERE IS NO INDICATION THAT A DESIGN OR PROCESS INDUCED 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. 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 THE 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) 2010. THE PT WAS NOT SUITABLE FOR THE ENDOVASCULAR REPAIR BECAUSE THE PT'S PROXIMAL NECK LENGTH WAS LESS THAN 15MM. THE PHYSICIAN PERFORMED THE PROCEDURE AS LABELED. THE PHYSICIAN DID ANGIOGRAPHY AND RECOGNIZED THE PROXIMAL TYPE I ENDOLEAK AND TYPE II ENDOLEAK FROM THE LUMBAR ARTERY. SO THE PHYSICIAN DID BALLOONING TWICE BY THE CODA AND THERE WAS REDUCED THE ENDOLEAK. HE ALSO DID BALLOONING TWICE AGAIN BY THE MAXI AND THE ENDOLEAK WAS MORE REDUCED. HE FINALLY DECIDED TO KEEP UNDER OBSERVATION BECAUSE HE THINKS THE ENDOLEAK WILL BE RESOLVED AFTER THE HEPARIN NEUTRALIZED. THE PT WAS KEPT UNDER OBSERVATION.

    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 F2563726

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention