BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT THORACIC STENT GRAFT SYSTEM (CT)

    MDR report key: 1725309 · Received June 11, 2010

    Report

    Report Number
    2953200-2010-01124
    Event Type
    Death
    Date Received
    June 11, 2010
    Date of Event
    October 11, 2012
    Report Date
    November 11, 2012
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). EVALUATION RESULTS AND CONCLUSION: (ENDOLEAK), (EMERGENT REPAIR OF A THORACIC AORTIC ANEURYSM).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE EMERGENT ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM 1.5 MONTHS AGO. ANEURYSM AND VESSEL MORPHOLOGY WERE NOT REPORTED. TWO STENT GRAFTS A (B) (4) AND A (B) (4) WERE IMPLANTED IN TURN FROM DISTAL TO PROXIMAL. POST IMPLANT THERE WAS NO ENDOLEAK; HOWEVER, ON A UNKNOWN DATE, A TYPE 1 ENDOLEAK WAS FOUND DURING FOLLOW-UP. AN ADDITIONAL THORACIC STENT GRAFT, A (B) (4) WAS IMPLANTED AT THE DISTAL END OF THE (B) (4) AND THE ENDOLEAK RESOLVED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FOR THIS CASE. THE PATIENT EXPECTORATED BLOOD AND PRESENTED AT THE HOSPITAL. THE PATIENT UNDERWENT ESOPHAGECTOMY TO TREAT AN AORTA-ESOPHAGEAL FISTULA. THE ANEURYSM DIAMETER DECREASED, THE AORTA WALL BECAME THIN AND RESULTED IN A FISTULA DEVELOPED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FOR THIS CASE. IT WAS REPORTED THAT AFTER THE ESOPHAGECTOMY THE PATIENT EXPIRED DUE TO FISTULA. THE PHYSICIAN STATED THAT THE AORTA WALL BECAME THIN DUE TO THE ANEURYSM, AND AORTA-ESOPHAGEAL FISTULA HAPPENED. FISTULA IS ONE OF KNOWN ISSUES OF TEVARS COMPLICATION, AND VERY OFTEN FOUND IT ON THE IMPENDING RUPTURE. IT DOESN'T HAVE RELATION WITH THE STENT GRAFT AND THE PHYSICIAN ALSO DISCLAIMED THE RELATION WITH THE STENT GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT THORACIC STENT GRAFT SYSTEM (CT) MIH MEDTRONIC CARDIOVASCULAR NA V00316426

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death| R