BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT XCELERANT BIFURCATED STENT GRAFT

    MDR report key: 2298502 · Received October 12, 2011

    Report

    Report Number
    2953200-2011-01776
    Event Type
    Injury
    Date Received
    October 12, 2011
    Date of Event
    March 1, 2010
    Report Date
    November 4, 2011
    Manufacturer
    MEDTRONIC CARVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL RESULTS: (GRAFT MIGRATION, ENDOLEAK). (DISEASE PROGRESSION AND AORTIC NECK DILATATION). CONCLUSION: (DISEASE PROGRESSION AND AORTIC NECK DILATATION).

    Additional Manufacturer Narrative · 1

    EVALUATION METHOD: (3D RECONSTRUCTION).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE TREATMENT OF A 6.2 CM ABDOMINAL AORTIC ANEURYSM APPROX 51 MONTHS AGO. THE VESSEL MORPHOLOGY AT THE TIME OF IMPLANT WAS REPORTED AS: THE AORTIC NECK WAS 24 MM IN DIAMETER AT THE RENAL ARTERIES AND 22 MM IN DIAMETER ABOVE THE ANEURYSM AND 22 MM LONG. THE DISTAL AORTA WAS 20 MM IN DIAMETER. THE COMMON ILIACS WERE 14 MM IN DIAMETER PROXIMALLY, AND THE LEFT ILIAC ALSO WAS ANEURYSMAL WITH A DIAMETER OF 22 MM. THE PT HAS BEEN MONITORED YEARLY. APPROX THREE YEARS POST STENT GRAFT IMPLANT, IT WAS NOTED THAT THE TOP END OF THE STENT GRAFT MIGRATED BUT WITHOUT A PROXIMAL TYPE I ENDOLEAK AT THAT TIME. THERE WAS NO INTERVENTION. A RECENT CT SCAN NOTED THAT THE TOP END OF THE TALENT HAD SEPARATED COMPLETELY FROM THE GRAFT MATERIAL AND SEPARATED FROM THE REST OF THE MAIN BODY. THE MAIN BODY HAS NOW MIGRATED DISTALLY AND THERE IS A PROXIMAL TYPE I ENDOLEAK, BUT NO ANEURYSM ENLARGEMENT AT THIS TIME. AN INTERVENTION WITH A PROXIMAL CUFF IS PLANNED FOR A LATER DATE. NO ADD'L CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE.

    Description of Event or Problem · 1

    THE 3D RECONSTRUCTION ANALYSIS OF THE PROVIDED IMAGES CONFIRMED THAT THE SUPRARENAL STENT IS FRACTURED; THIS FRACTURE IS ACTUALLY FIRST EVIDENT IN THE CT SCAN RATHER THAN IN THE SCAN. THE STENT GRAFT ALSO MIGRATED INTO THE ANEURYSM SAC; WHETHER THIS MIGRATION IS A RESULT OF THE FRACTURE OR A CAUSE OF THE FRACTURE IS UNKNOWN. A PROXIMAL TYPE I ENDOLEAK IS ALSO APPARENT IN THE SCAN. THE CAUSE OF THE STENT GRAFT FRACTURE IS NOT APPARENT. THE ONLY ABNORMALITY IDENTIFIED IS A SHARP BEND IN THE CONNECTING BAR FOR THE SEAL STENT IN THE INITIAL IMPLANTATION; IT IS POSSIBLE THE STENT GRAFT REACTED TO THIS STRESS BY CURVING OUT INTO THE VOLUME OF THE ANEURYSM SAC, CONSEQUENTLY PUTTING EXCESSIVE STRAIN ON THE SUPRARENAL STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT XCELERANT BIFURCATED STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARVASCULAR NA V00011350

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention