BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX UNK

    MDR report key: 1061436 · Received June 17, 2008

    Report

    Report Number
    2953200-2008-00426
    Event Type
    Injury
    Date Received
    June 17, 2008
    Date of Event
    April 20, 2008
    Report Date
    May 22, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS - INHERENT RISK OF PROCEDURE (ENDOLEAK, MIGRATION RUPTURE). LACK OF INFO (NO FILMS OR OPERATIVE REPORTS WERE RECEIVED). CONCLUSION: LACK OF INFO (NO FILMS OR OPERATIVE REPORTS WERE RECEIVED). REQUIRED SECONDARY INTERVENTION.

    Description of Event or Problem · 1

    AN UNK SIZE ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY WERE NOT REPORTED. IT WAS REPORTED THAT THE ANEURYSM WAS FOUND TO HAVE RUPTURED APPROXIMATELY 8 WEEKS AGO. THERE WAS 15 MM DISTAL STENT GRAFT MIGRATION, THE CONTRALATERAL LIMB HAD SEPARATED FROM THE MAIN DEVICE AND THERE WERE TYPE 1 ENDOLEAKS PROXIMALLY AND DISTALLY. ALSO THE STENT HAD SEPARATED FROM THE GRAFT. A RE-INTERVENTION WAS SUCCESSFULLY PERFORMED WITH ANOTHER MANUFACTURER'S STENT GRAFT. THROMBUS HAD COLLECTED WITHIN THE ANEURX STENT GRAFT; THEREFORE, A THROMBECTOMY PROCEDURE WAS PERFORMED. NO ADD'L CLINICAL SEQUELAE WERE REPORTED AND THE PT TOLERATED THE PROCEDURE IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX UNK MIH MEDTRONIC CARDIOVASCULAR NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention