BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT AUI

    MDR report key: 3920300 · Received July 8, 2014

    Report

    Report Number
    2953200-2014-01369
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    May 2, 2014
    Report Date
    August 14, 2014
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A TALENT AAA STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY WERE NOT REPORTED. IT WAS REPORTED THAT THE PATIENT CAME IN WITH BACK PAIN. AN ANGIOGRAM WAS DONE AND THE SURGEON DESCRIBED THE TALENT GRAFT TO HAVE FABRIC TEARS AND PORES. ANOTHER MANUFACTURER¿S STENT GRAFT WAS IMPLANTED RESOLVING THE TYPE III ENDOLEAKS. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Description of Event or Problem · 1

    FILM REVIEW ANALYSIS: CTA'S FROM 5 YEARS POST-IMPLANT REVEALED THAT THE AUI WAS POSITIONED JUST BELOW THE RENALS, AND EXTENDED DISTALLY INTO THE RIGHT COMMON ILIAC. A FEM-FEM BYPASS WAS VISIBLE. THE MAX DIAMETER AAA WAS 4.5CM AND THE STENT GRAFT IS PATENT. CONTRAST WAS SEEN NEAR THE MID-LEVEL OF THE POSTERIOR SAC WALL. THIS MAY BE A TYPE III FABRIC OR A TYPE II ENDOLEAK. NO OTHER ISSUES WERE SEEN. CTA'S FROM 6 YEARS POST-IMPLANT SHOWED THE STENT GRAFT JUST BELOW THE RENALS. THERE IS SLIGHT AMOUNT OF CONTRAST SEEN IN THE PROXIMAL SAC; ENDOLEAK TYPE IS UNKNOWN BUT THIS MAY BE A PROXIMAL TYPE I OR A TYPE III FABRIC. THE MAX DIAMETER AAA WAS 4.5CM AND THE STENT GRAFT IS PATENT. CTA'S FROM 8 YEARS POST-IMPLANT REVEALED THAT A LARGER AMOUNT OF CONTRAST WAS SEEN IN THE PROXIMAL AND MID-SAC. THIS MAY BE A TYPE III OR TYPE I PROXIMAL. THERE IS ALSO DILATATION OF THE RIGHT COMMON ILIAC, WITH CONTRAST SEEN OUTSIDE THE ILIAC LIMB. THE MAX AAA DIAMETER HAS INCREASED TO 6CM. ANGIO STUDY IMAGES SHOWED CONTRAST IN THE SAC FROM A LIKELY TYPE III FABRIC ENDOLEAK NEAR THE LEVEL OF THE 2ND OR 3RD COVERED STENT. THE ENDOLEAK LOCATION AND TYPE WAS INTERROGATED USING AN INFLATED BALLOON IN DIFFERENT STENT GRAFT LOCATIONS PROXIMAL AND DISTAL TO THE CONTRAST. THE CAUSE COULD NOT BE DETERMINED. PER NOTES ON THE FILMS, A COOK 28 /12 X80MM STENT GRAFT, FOLLOWED BY A 16X74MM AND A 30 X 39MM STENT GRAFT WERE THEN IMPLANTED ACROSS THE LENGTH OF THE AUI. THE ENDOLEAK APPEARED TO HAVE RESOLVED AT THE FINAL ANGIO. THE CAUSE OF THE ENDOLEAK COULD NOT BE CONFIRMED. CTA'S FROM THE NEXT DAY SHOWED CONTRAST OUTSIDE THE AUI NEAR THE PROXIMAL NECK; THE CAUSE COULD NOT BE DETERMINED. THE MAXIMUM AAA OD WAS 6CM. NO OTHER ENDOLEAK OR ANY OTHER STENT GRAFT ISSUES WERE OBSERVED. CTA'S AGAIN SHOW CONTRAST NEAR THE PROXIMAL NECK, AND MAXIMUM AAA DIAMETER WAS 5.9CM. A 6CM LENGTH SECTION FROM AN UNKNOWN CATHETER/PROBE WAS SEEN IMPLANTED OUTSIDE THE STENT GRAFT JUST BELOW THE RIGHT KIDNEY. NO OTHER DEVICE ISSUES WERE OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    397663 TALENT AUI SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA 690698

    Patients

    Seq Age Sex Outcome Treatment
    1 00090 YR Required Intervention