BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELIANT STENT GRAFT BALLOON CATHETER

    MDR report key: 1222406 · Received November 5, 2008

    Report

    Report Number
    2953200-2008-01008
    Event Type
    Injury
    Date Received
    November 5, 2008
    Date of Event
    October 6, 2008
    Report Date
    October 6, 2008
    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

    EVALUATION RESULTS AND CONCLUSION: (ARTERIAL TRAUMA/DISSECTION/PERFORATION); (SEVERELY CALCIFIED AND FRAIL VESSELS). PT CODE: OTHER: SECONDARY INTERVENTION REQUIRED.

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS INSERTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM MORPHOLOGY WAS NOT REPORTED. VESSEL MORPHOLOGY WAS REPORTED AS SEVERELY CALCIFIED AND FRAIL VESSELS. IT WAS REPORTED THAT PHYSICIAN WAS MODELING THE STENT GRAFT WITH A RELIANT BALLOON. WHILE INFLATING THE BALLOON, THE VESSEL WALL WAS PERFORATED. (MDR2953200-2008-01009). THE BALLOON WAS COMPLETELY WITHIN THE STENT GRAFT WHILE THE BALLOON WAS BEING INFLATED. THE PHYSICIAN PLACED AN AORTIC CUFF TO TREAT THE PERFORATED VESSEL. NO ADD'L CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention