BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM - HYDRO

    MDR report key: 1930717 · Received December 14, 2010

    Report

    Report Number
    2953200-2010-02531
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    November 13, 2010
    Report Date
    November 15, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: LARGE AORTIC NECK. ANEURYSM RUPTURE. EVAL, CONCLUSION: LARGE AORTIC NECK.

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 31 MONTHS AGO. ANEURYSM MORPHOLOGY AT THE TIME OF IMPLANT IS UNK. THE INFRARENAL AORTIC NECK WAS SHORT AND MEASURED 35 MM IN DIAMETER AND THEN PINCHED DOWN TO LESS THAN 26 MM IN DIAMETER. THE PT WAS NOT A SURGICAL CANDIDATE. IT WAS REPORTED THAT DUE TO THE DIFFICULT NECK ANATOMY, AN ANEURX CUFF WAS ALSO IMPLANTED PROXIMALLY IN A PLANNED PLACEMENT; HOWEVER, THE ORIGINAL PLACEMENT POSITION OF THE CUFF IS UNK. THE PT WAS LOST TO F/U AND PRESENTED EMERGENTLY ON (B)(4) 2010, WITH PROXIMAL TYPE 1 ENDOLEAK AND A RUPTURED ANEURYSM. THE CUFF WAS LOCATED 15 MM BELOW THE RENAL ARTERIES, BUT STENT GRAFT MIGRATION CANNOT BE CONFIRMED. THE PHYSICIAN CONVERTED THE PT TO AN OPEN REPAIR AND EXPLANTED THE STENT GRAFTS (SEE MFR # 2953200-2010-02530). THE EXPLANTED STENT GRAFTS WERE DISCARDED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX AAADVANTAGE STENT GRAFT SYSTEM - HYDRO MIH MEDTRONIC CARDIOVASCULAR NA V00058532Y

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention