BEUDAMED
    FDA Adverse Event Death Summary report: N

    TALENT CONVERTER STENT GRAFT

    MDR report key: 2140902 · Received June 22, 2011

    Report

    Report Number
    2953200-2011-01170
    Event Type
    Death
    Date Received
    June 22, 2011
    Date of Event
    April 13, 2011
    Report Date
    June 30, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: (ENDOLEAK, DEATH, BLOOD LOSS). RESULTS/CONCLUSIONS: (TYPE II ENDOLEAK), (UNK CAUSE OF DEATH).

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROX 4 YRS AGO. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT WERE NOT REPORTED. IT WAS REPORTED THAT THE ANEURX BIFURCATED STENT GRAFT (MFR REPORT # 2953200-2011-01171) MIGRATED DISTALLY, RESULTING IN A PROXIMAL TYPE I ENDOLEAK. THE CAUSE OF THE MIGRATION IS UNK. THE PHYSICIAN ELECTED TO INTERVENE BY IMPLANTING A TALENT CONVERTER STENT GRAFT (MFR REPORT # 2953200-2011-01170) AND PERFORMING A FEMORAL-FEMORAL BYPASS APPROX 2 MONTHS AGO. WHEN IMPLANTING THE TALENT CONVERTER STENT GRAFT, A PROXIMAL TYPE I ENDOLEAK AND A TYPE II ENDOLEAK WERE NOTED. NO INTERVENTION WAS REPORTED FOR THE ENDOLEAKS. THERE WAS ALSO 1500 ML OF BLOOD LOSS DURING THE PROCEDURE. THE BLOOD LOSS WAS ASSESSED TO BE UNRELATED TO THE DEVICE AND DEFINITELY RELATED TO THE PROCEDURE. MEDICATION AND A TRANSFUSION WERE GIVEN, AND THE BLOOD LOSS RESOLVED. IT WAS LATER REPORTED THAT THE PT EXPIRED AT A NURSING HOME. NO FURTHER INFO HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    FILMS WERE REVIEWED INTERNALLY AS FOLLOWS: FILMS AT 4 YEARS POST-IMPLANT SHOW THAT THE ANEURX BIFURCATED STENT GRAFT (MFR REPORT #2953200-2011-01171) IS APPROXIMATELY 5-10 MM BELOW THE RENALS. THE PROXIMAL NECK IS SHORT AND ANGULATED, WITH CIRCUMFERENTIAL CALCIFICATION. THERE IS A PROXIMAL TYPE I AND TYPE 11 ENDOLEAK. AFTER THE CONVERTER (MFR REPORT #2953200-2011-01170) WAS IMPLANTED, FILMS SHOW THAT A SMALL PROXIMAL TYPE I ENDOLEAK AND A TYPE 11 ENDOLEAK ARE STILL VISIBLE. THE CAUSE OF THESE EVENTS ARE LIKELY RELATED TO THE NECK MORPHOLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT CONVERTER STENT GRAFT MIH MEDTRONIC CARDIOVASCULAR IRELAND NA V00392176

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Female Death UNK