BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELIANT STENT GRAFT BALLOON CATHETER

    MDR report key: 1397920 · Received May 29, 2009

    Report

    Report Number
    2953200-2009-00670
    Event Type
    Injury
    Date Received
    May 29, 2009
    Date of Event
    April 30, 2009
    Report Date
    April 30, 2009
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    DQY
    PMA / PMN Number
    K050038
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (SECONDARY INTERVENTION) CONCLUSIONS: ( NO FILMS ARE AVAILABLE FOR THIS CASE).

    Description of Event or Problem · 1

    A TALENT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN 8.2 CM X 6.3 CM ABDOMINAL AORTIC ANEURYSM. THE AORTIC NECK WAS 39 MM LONG, 25 TO 30 MM IN DIAMETER, AND MODERATELY CALCIFIED. IT WAS REPORTED THAT AFTER THE STENT GRAFT SYSTEM WAS IMPLANTED AND THE PHYSICIAN ELECTED TO MODEL THE STENT GRAFT WITH A RELIANT BALLOON. THE RELIANT BALLOON WAS COMPLETELY WITH IN THE ILIAC STENT GRAFT, HOWEVER, WHEN THE BALLOON WAS INFLATED IT APPEARED THAT THE ILIAC STENT GRAFT WAS TORN (MFR REPORT# 2952300-2009-00669). THERE WAS A TYPE III ENDOLEAK (FABRIC TEAR) THAT WAS OPENING INTO THE ANEURYSM. THE PHYSICIAN ELECTED TO IMPLANT A WALL GRAFT, WITH SUCCESSFUL RESULTS. THE BALLOON WAS USED FOR THE REST OF THE CASE WITHOUT ISSUES (MFR REPORT# 2952300-2009-00670). NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RELIANT STENT GRAFT BALLOON CATHETER DQY MEDTRONIC CARDIOVASCULAR NA 0000974128

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention