BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT THORACIC

    MDR report key: 3081573 · Received April 29, 2013

    Report

    Report Number
    2953200-2013-00800
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    July 5, 2011
    Report Date
    April 4, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (RE-OPERATION). (INSUFFICIENT INFORMATION; CAUSE OF THE PROXIMAL EXTENSION IS UNKNOWN). EVALUATION CONCLUSION: KNOWN INHERENT RISK OF PROCEDURE (RE-OPERATION). (INSUFFICIENT INFORMATION; CAUSE OF THE PROXIMAL EXTENSION IS UNKNOWN).

    Description of Event or Problem · 1

    A TALENT THORACIC STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM. THE ANEURYSM AND VESSEL MORPHOLOGY WERE NOT REPORTED. IT WAS REPORTED THAT A SECONDARY INTERVENTION WAS DONE 10 MONTHS POST INDEX PROCEDURE. THE STENT GRAFT WAS EXTENDED PROXIMALLY WITH A TALENT 46X46X157 AND A TALENT 42X42X158. IT IS UNKNOWN IF THIS SECONDARY INTERVENTION WAS DONE TO TREAT AN ENDOLEAK, OR IF IT WAS PLANNED AS THE SECOND STAGE OF THE PATIENT'S ENDOVASCULAR REPAIR. THE SECONDARY INTERVENTION MAY HAVE BEEN DONE IN CONJUNCTION WITH AN OPEN REPAIR TO REPLACE THE AORTIC ARCH WITH A SURGICAL GRAFT. APPROXIMATELY 2.5 YEARS POST INDEX PROCEDURE, THE PATIENT UNDERWENT AN OPEN SURGICAL REPAIR TO TREAT A DISTAL TYPE I ENDOLEAK WITH DISEASE PROGRESSION AND AORTIC DILATATION TO 42MM. THE MOST DISTAL TALENT 44X40X111 STENT GRAFT WAS EXPLANTED AT THIS TIME. THE PHYSICIAN NOTED THAT THE PATIENT'S AORTA WAS FALLING APART, POSSIBLY DUE TO A CONNECTIVE TISSUE DISORDER. THE PHYSICIAN NOTED THAT THE PATIENT UNDERWENT A TOTAL OF SIX ENDOVASCULAR SURGERIES. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184585 TALENT THORACIC SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR V00212146

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Required Intervention