BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM

    MDR report key: 2251400 · Received September 13, 2011

    Report

    Report Number
    2953200-2011-01580
    Event Type
    Injury
    Date Received
    September 13, 2011
    Report Date
    August 15, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS - OCCLUSION, INFECTION, SURGICAL CONVERSION TO OPEN REPAIR. LACK OF INFO, CAUSE OF EVENT IS UNK. CONCLUSION - LACK OF INFO, CAUSE OF EVENT IS UNK.

    Description of Event or Problem · 1

    AN ANEURX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A 5.4 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM APPROX 54 MONTHS AGO. VESSEL MORPHOLOGY AT THE TIME OF IMPLANT WAS NOT REPORTED. THE FOLLOWING EVENTS WERE REPORTED. TWO YEARS POST INDEX PROCEDURE, THE PT HAD AN AV FISTULA REPAIR ON THE RIGHT GROIN. THE PT ALSO HAD THREE PROCEDURES, EACH A MONTH APART, SEARCHING FOR AN UNK ENDOLEAK. TWO MONTHS LATER, THE PT HAD AN ANGIOGRAM AND THERE WAS A PROXIMAL TYPE I ENDOLEAK PRESENT. IT WAS REPORTED THAT THE PT RETURNED A MONTH AFTER THE ENDOLEAK WAS NOTED FOR AN UNK REASON (MOST LIKELY DUE TO MIGRATION AND A TYPE I ENDOLEAK OF THE STENT GRAFT). (MFR REPORT# 2953200-2011-01578, 2953200-2011-01579) THE PT HAD TWO AORTIC CUFFS IMPLANTED. (MFR REPORT# 2953200-2011-01581, 2953200-2011-01582) A YEAR LATER, THE PT HAD ANOTHER ANGIOGRAM FOR A POSSIBLE ENDOLEAK. THE PT PRESENTED A MONTH AFTER THE ANGIOGRAM WITH OCCLUSION OF THE RIGHT ILIAC ARTERY AND WAS TREATED WITH AN ENDARTERECTOMY. (MFR REPORT# 2953200-2011-01580) A MONTH LATER, THE PT HAD TREATMENT FOR A RIGHT GROIN INFECTION. FOUR MONTHS LATER, THE ANGIOGRAM REVEALED THAT THERE WAS A TYPE I ENDOLEAK AND TYPE II ENDOLEAK. PRESENTLY, THE PHYSICIAN ELECTED TO EXPLANT THE STENT GRAFT. IT WAS REPORTED THAT PRIOR TO THE REMOVAL OF THE STENT GRAFT THE ANEURYSM WAS 7.2 CM IN DIAMETER. THE ANEURYSM CONTINUED TO ENLARGE DUE TO THE TYPE I AND TYPE II ENDOLEAKS. NO ADD'L CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX AAADVANTAGE STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA 1000099

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention