BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH RENU CONVERTER AAA ANCILLARY GRAFT

    MDR report key: 1003271 · Received February 27, 2008

    Report

    Report Number
    1820334-2008-00112
    Event Type
    Injury
    Date Received
    February 27, 2008
    Date of Event
    April 5, 2006
    Report Date
    January 28, 2008
    Manufacturer
    COOK INCORPORATED
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A MALE PATIENT UNDERWENT AAA REPAIR TO FIX A TYPE III ENDOLEAK DUE TO A GRAFT TEAR OF THE PRE-EXISTING GRAFT OF ANOTHER MANUFACTURER. AFTER THE RENU PROCEDURE IN 2006, THE 30 DAY FOLLOW-UP IMAGING NOTED THE PRE-EXISTING GRAFT WAS NOT PATENT AND A TYPE II ENDOLEAK WAS PRESENT. A CORE LAB REVIEW OF THE PROCEDURAL ANGIOGRAM REPORTS A PROBABLE TYPE I ENDOLEAK, AFTER THE RENU DEVICE WAS COMPLETELY IMPLANTED. NO OTHER CORE LAB REVIEW OF THIS PATIENT'S IMAGING HAVE BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH RENU CONVERTER AAA ANCILLARY GRAFT MIH ENDOVASCULAR GRAFT MIH COOK INCORPORATED NA 1549877

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other