BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM

    MDR report key: 1101746 · Received August 7, 2008

    Report

    Report Number
    2953200-2008-00661
    Event Type
    Injury
    Date Received
    August 7, 2008
    Report Date
    July 16, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A TALENT THORACIC STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A TYPE B DISSECTION. THIS EVENT WAS REPORTED IN THE JOURNAL OF VASCULAR SURGERY 2008; 47: 1195-1202, JUNE 2008. THE STENT GRAFTS WERE IMPLANTED IN 2002. IT WAS REPORTED THAT THE PATIENT WAS TREATED 4 YEARS LATER WITH AN ENDOGRAFT AND THE COVERED PROXIMAL PART WAS DEPLOYED JUST DISTALLY TO THE LEFT CAROTID ARTERY. THE PATIENT PRESENTED 9 MONTHS LATER WITH A SMALL PROXIMAL TYPE 1A ENDOLEAK AND LARGE TYPE 2 ENDOLEAK CAUSED BY THE LEFT SUBCLAVIAN ARTERY BACK BLEEDING. DESPITE SUCCESSFUL SEALING OF THE SUBCLAVIAN ARTERY BY MEANS OF AN OCCLUDER DEVICE, THE ANEURYSM SAC WAS STILL PRESSURIZED BY THE TYPE 1A ENDOLEAK WITH SUBSEQUENT ENLARGEMENT OF THE ARCH AND DESCENDING ANEURYSM. REPEAT ATTEMPTS TO ACHIEVE APPOSITION IN THE ARCH OR ENDOVASCULAR EXTENSION AS PART OF A HYBRID PROCEDURE WERE CONSIDERED INAPPROPRIATE IN THIS PATIENT. THE PATIENT WAS TREATED BY ELECTIVE CONVERSION PROCEDURE INVOLVING HEMI ARCH AND DESCENDING AORTIC REPLACEMENT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT THORACIC STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention