BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO

    MDR report key: 1923744 · Received December 9, 2010

    Report

    Report Number
    2953200-2010-02500
    Event Type
    Injury
    Date Received
    December 9, 2010
    Date of Event
    November 5, 2010
    Report Date
    November 10, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: REACTION, MEDICATION ADMINISTERED TO THE PT. EVAL, CONCLUSION: EXTREMELY TORTUOUS VESSELS, MEDICATION ADMINISTERED TO THE PT.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT WERE NOT REPORTED. IT WAS REPORTED THAT THE PT HAD AN ALLERGIC REACTION DESCRIBED AS A BURNING SENSATION. IT WAS NOTED THAT THIS MAY BE RELATED TO THE MEDICATION ADMINISTERED. THE WBC WENT FROM 6 BEFORE THE PROCEDURE TO 12 AFTER THE PROCEDURE WHICH WAS NOTED TO BE TYPICAL OF THESE PROCEDURES. THE PT WAS GIVEN BENADRYL. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE (REF MFR # 2953200-2010-02497, 2953200-2010-02498, AND 2953200-2010-02599).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00422240

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention