BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 2090910 · Received May 12, 2011

    Report

    Report Number
    1820334-2011-00234
    Event Type
    Injury
    Date Received
    May 12, 2011
    Date of Event
    April 12, 2011
    Report Date
    April 15, 2011
    Manufacturer
    COOK INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PT OUTCOME WAS PROVIDED BY REPORTER. ENDOLEAKS ARE LABELED IN THE IFU. NO PRODUCT OR IMAGES WERE RETURNED TO ASSIST IN THE INVESTIGATION AT THIS TIME. 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. BY REPORT, THE DEVICE WAS USED OFF-LABEL BECAUSE OF ANATOMICAL EXCLUSION. PER THE IFU, THE DEVICE IS INTENDED FOR PTS WITH AN INFRARENAL NECK WITH A LENGTH OF AT LEAST 15 MM. INFRARENAL NECK SHAPE AND LENGTH LIKELY RESULTED IN AN INSUFFICIENT SEAL AND TYPE IA ENDOLEAK. TORTUOSITY OF THE RIGHT COMMON WAS REPORTED AND LIKELY CONTRIBUTED TO THE TYPE IB. THE TYPE IB WAS RESOLVED AFTER BALLOONING AND PLACEMENT OF ANOTHER MANUFACTURER'S STENT REDUCING THE TYPE IA. THE PHYSICIAN DECIDED TO TAKE A WAIT-AND-SEE APPROACH AFTER THE INTERVENTION DESCRIBED ABOVE. 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

    AN (B)(6) MALE PT UNDERWENT AAA REPAIR ON (B)(6) 2011. THE PT'S ANATOMICAL FORM WAS NOT SUITABLE FOR THE PROCEDURE SINCE PROXIMAL NECK LENGTH WAS 12MM AND RIGHT COMMON ILIAC ARTERY BEHAVIOR WAS NOT GOOD. MOREOVER, PROXIMAL NECK WAS FUNNEL SHAPE, INCREASED FROM "24MM TO 21MM." HOWEVER, THE PHYSICIAN SELECTED ZENITH DEVICE AS THE PT WAS AT AN OLD AGE. CONFIRMATORY ANGIOGRAPHY AFTER DEVICES WERE PLACED, REVEALING PROXIMAL TYPE I ENDOLEAK, DISTAL TYPE I ENDOLEAK, AND TYPE II ENDOLEAK. REGARDING THE PROXIMAL TYPE I ENDOLEAK, BALLOONING WAS PERFORMED BUT IT WAS NOT RESOLVED. THEN ANOTHER MANUFACTURER'S XL STENT WAS PLACED AND IT WAS REDUCED. FOR DISTAL TYPE I ENDOLEAK FROM SEALING PART OF COMMON ILIAC ARTERY, IT WAS RESOLVED AFTER RE-BALLOONING. ADDITIONAL ANGIOGRAPHY REVEALED AN ENDOLEAK STILL REMAINED. THE PHYSICIAN CONSIDERED IT AS TYPE IV ENDOLEAK AND DECIDED TO TAKE FOLLOW-UP OBSERVATION SINCE AMOUNT OF LEAKAGE WAS REDUCED. (1820334-2011-00235) ACT WAS BETWEEN 308 AND 330. THE PT'S CONDITION AFTER THE PROCEDURE IS UNK, BUT THERE IS POSSIBILITY OF ANEURYSM GROWTH.

    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 F2579105

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention