BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG

    MDR report key: 2081252 · Received April 26, 2011

    Report

    Report Number
    1820334-2011-00205
    Event Type
    Injury
    Date Received
    April 26, 2011
    Date of Event
    March 28, 2011
    Report Date
    March 30, 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

    EVENT EVAL: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A (B)(6) MALE PT UNDERWENT AAA AND LEFT AND RIGHT EIA ANEURYSM REPAIR ON (B)(6) 2011. HE HAD AAA AND CIA ANEURYSM. THE PT'S ANATOMICAL FORM WAS SUITABLE FOR ENDOVASCULAR REPAIR. FINAL CONFIRMATORY ANGIOGRAPHY SHOWED BOTH PROXIMAL AND DISTAL TYPE I ENDOLEAKS, AND TYPE II ENDOLEAK. FOR THE PROXIMAL TYPE I ENDOLEAK, REBALLOONING AND ANOTHER BALLOONING BY ANOTHER MFR'S 25MM X 40MM WERE PERFORMED, BUT THESE WERE NOT EFFECTIVE. THE ENDOLEAK WAS RESOLVED AFTER PLACING ANOTHER MFR'S XL STENT (1820334-2011-00204); REGARDING THE DISTAL TYPE I ENDOLEAK FROM THE LEFT ILIAC LEG PLACED IN EIA, THE SEALING POINT WAS A BIT LARGER THAN 9MM, SO THE ILIAC LEG WITH 12MM OF DIAMETER WAS CHOSEN. SINCE THE GRAFT WAS NOT EXPANDED SUFFICIENTLY, REBALLOONING WAS PERFORMED BUT FAILED. ANOTHER MFR'S 12MM X 40MM STENT WAS PLACED AND POWERFLEX 9MM X 20MM WAS USED FOR BALLOONING. HOWEVER, THE ENDOLEAK WAS NOT RESOLVED. THE PHYSICIAN OCCLUDED THE DISTAL AND THE JUNCTION PARTS BY BALLOONING TO TAKE ANGIOGRAPHY, THEN IT WAS REVEALED THAT THE ENDOLEAK WAS ACTUALLY A TYPE IV. (ACT WAS AROUND 300 AT THAT TIME.) HE DECIDED TO TAKE A WASH-AND-SEE APPROACH. THE PT'S CONDITION IS UNK WAS NOT PROVIDED BY REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention