BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2963980 · Received February 15, 2013

    Report

    Report Number
    2953200-2013-00267
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    May 29, 2009
    Report Date
    January 23, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK). PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (TYPE II ENDOLEAK). CONCLUSIONS: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (TYPE II ENDOLEAK).

    Description of Event or Problem · 1

    AN ENDURANT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 49 MONTHS AGO. IT WAS REPORTED THAT AT THE SIX MONTH FOLLOW-UP APPOINTMENT THERE WAS AN UNKNOWN ENDOLEAK; HOWEVER, THIS EVENT DID NOT RESULT IN A NEW CLINICAL EVENT. IT WAS ALSO REPORTED AT THE TIME OF IMPLANT THERE WAS AN UNCORRECTED TYPE IIB ENDOLEAK COMING FROM MULTIPLE COLLATERAL VESSELS. A 3D VOLUME STUDY SHOWED CONTINUED SLOW EXPANSION OF THE ANEURYSM SAC DUE TO THE TYPE II ENDOLEAK. THE TYPE II ENDOLEAK WAS TREATED WITH PERCUTANEOUS TRANS-LUMBAR COIL EMBOLIZATION. THE INVESTIGATOR ASSESSED THE TYPE II ENDOLEAK AS NOT DEVICE RELATED AND PROCEDURE RELATED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66453 ENDURANT ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA V00112715

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention