BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT XCELERANT-HYDRO

    MDR report key: 1963318 · Received January 14, 2011

    Report

    Report Number
    2953200-2011-00119
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    January 1, 2011
    Report Date
    November 9, 2012
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION - RESULTS: (ENDOLEAK), OTHER (SOURCE OF ENDOLEAK IS UNK). CONCLUSION: OTHER (SOURCE OF ENDOLEAK IS UNK).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT HAD ANEURYSMAL GROWTH OF 8MM AT THE 2 YEAR FOLLOW UP. EXACT EVENT DATE IS UNKNOWN.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A 5.9 CM ABDOMINAL AORTIC ANEURYSM. AT IMPLANT THE ANEURYSM WAS FUSIFORM WITH A 12 DEGREE INFRARENAL ANGLE; 31 MM AORTIC NECK. THERE WAS A LEFT ILIAC ANEURYSM WITH A 24 MM DIAMETER X 25 MM LENGTH. THE VESSEL MORPHOLOGY IS REPORTED AS HAVING MILD BILATERAL ILIAC TORTUOSITY. A TYPE IV ENDOLEAK WAS OBSERVED AT THE END OF THE PROCEDURE. THIS WAS NOT CORRECTED. A TYPE IIA, POSTERIOR, LUMBAR ORIGIN ENDOLEAK WAS NOTED AS A NEW EVENT ON THE CT WITH CONTRAST AT THE 1 MONTH VISIT. NO TYPE IV ENDOLEAK WAS NOTED. AT THE 12 MONTH REVIEW, THE ULTRASOUND SHOWED AN ENDOLEAK, TYPE UNDETERMINED, THAT WAS NOTED AS HAVING BEEN SEEN ON THE LAST SCAN DATE. NO ADDITIONAL DETAILS HAVE BEEN OBTAINED. NO CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED: IT WAS REPORTED THAT THERE IS 1 MM OF ANEURYSM GROWTH NOTED IN THE 3 YEAR SITE IMAGE REPORT. THE ANEURYSM AT TWO YEAR FOLLOW UP WAS 6.5 CM IN DIAMETER AND CURRENTLY THE DIAMETER IS 6.6 CM IN DIAMETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL STENT GRAFT XCELERANT-HYDRO SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00386356

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention