BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT XCELERANT

    MDR report key: 3233956 · Received July 18, 2013

    Report

    Report Number
    2953200-2013-01383
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    April 11, 2012
    Report Date
    August 23, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK); (UNKNOWN CAUSE OF EVENT). CONCLUSION: (UNKNOWN CAUSE OF EVENT); KNOWN INHERENT RISK OF A PROCEDURE (ENDOLEAK).

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: FILM. RESULTS, CONCLUSION: ANATOMY RELATED; DISEASE PROGRESSION, TYPE II ENDOLEAK.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED STATING THE PATIENT WAS TREATED WITH FOUR VALIANT STENT GRAFTS WHICH WERE EXTENDED DISTALLY RESOLVING THE DISTAL TYPE I ENDOLEAK. PER THE FILM REVIEW THE DISTAL STENT GRAFT ALSO CONTAINED LARGE AMOUNTS OF THROMBUS; APPROXIMATELY 25 PERCENT OCCLUDED. FILM REVIEW ANALYSIS: CTA'S FROM 2 YEARS POST-IMPLANT SHOW THAT THE TALENT STENT GRAFTS WERE IMPLANTED FROM DISTAL TO THE LSA, EXTENDING TO APPROXIMATELY 4-5 CM PROXIMAL TO THE CELIAC. CONTRAST IS SEEN NEAR THE MOST DISTAL STENT GRAFT; LIKELY TYPE II. THE DISTAL STENT GRAFT OD IS 48 X 52CM; APPEARS TO BE FULLY EXPANDED (57MM LUMEN DIAMETER). THE REPORTED DISTAL TYPE I ENDOLEAK COULD NOT BE SEEN; HOWEVER, WITH LACK OF STENT GRAFT APPOSITION WITH THE DISTAL THORACIC AORTA, THE TAA WAS LIKELY PRESSURIZED. THE DISTAL STENT GRAFT ALSO CONTAINED LARGE AMOUNTS OF THROMBUS; APPROXIMATELY 25 PERCENT OCCLUDED. IMAGES AT 2-YEARS SHOWED THAT THE STENT GRAFTS HAVE BEEN EXTENDED DISTALLY (4 STENT GRAFTS) TO JUST PROXIMAL TO THE CELIAC, WHERE THE OD OF THE MOST DISTAL STENT GRAFT WAS 24MM. NO ENDOLEAK WAS SEEN. EARLIER POST-IMPLANT IMAGES WERE NOT RETURNED; IT IS POSSIBLE THAT DISEASE PROGRESSION MAY HAVE CONTRIBUTED TO THE REPORTED DISTAL TYPE I ENDOLEAK. DATE OF THIS REPORT SHOULD HAVE BEEN (B)(6) 2012 IN THE INITIAL 3500 A. CORRECTION: DATE RECEIVED BY MANUFACTURER SHOULD HAVE BEEN (B)(6) 2012 IN THE INITIAL 3500 A.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT 6 CM DIAMETER THORACIC AORTIC ANEURYSM APPROXI MATELY FOUR YEARS AGO. THE PROXIMAL AORTA WAS 29 MM IN DIAMETER AND 91 MM IN LENGTH. DISTAL AORTA WAS 39 MM IN DIAMETER. RIGHT AND LEFT ILIAC ARTERIES WERE 9 MM IN DIAMETER. THE RIGHT AND LEFT FEMORAL ARTERIES WERE 9 MM IN DIAMETER. THE AORTA HAS MILD TORTUOSITY AND THROMBUS IS PRESENT. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A DISTAL TYPE I ENDOLEAK AND A TYPE II ENDOLEAK TWO YEARS AFTER INITIAL IMPLANT AND WAS LEFT UNCORRECTED. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333701 TALENT XCELERANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00271027

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR Other| R