BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO

    MDR report key: 1760601 · Received July 14, 2010

    Report

    Report Number
    2953200-2010-01320
    Event Type
    Injury
    Date Received
    July 14, 2010
    Date of Event
    June 12, 2010
    Report Date
    June 14, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVAL RESULTS: (ENDOLEAK). (SHORT, REVERSE-FUNNEL SHAPED AORTIC NECK WITH MODERATE ANGULATION). (USE OF THE DEVICE IN A PATIENT WHO WAS NOT AN APPROPRIATE ENDOVASCULAR REPAIR CANDIDATE).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A 5.1 CM ABDOMINAL AORTIC ANEURYSM APPROX 4 MONTHS AGO. THE PT WAS DESCRIBED AS NOT BEING AN APPROPRIATE ENDOVASCULAR REPAIR CANDIDATE; THE AORTIC NECK WAS SHORT AT 5 TO 7 MM IN LENGTH, HAD 50-60 DEGREE ANGULATION, AND WAS REVERSE-FUNNEL SHAPED WITH A DIAMETER OF 26 MM, WHICH THEN ENLARGED TO 31 MM IN DIAMETER OVER A LENGTH OF 10 MM. ILIAC VESSELS WERE DISEASED AND HAD THROMBUS THROUGHOUT BUT OTHERWISE UNREMARKABLE TORTUOSITY AND CALCIFICATION. IT WAS REPORTED THAT THE TALENT BIFURCATED STENT GRAFT WAS IMPLANTED WITHOUT ISSUES. HOWEVER, APPROX 1 MONTH AGO, THE PT PRESENTED WITH A LARGE PROXIMAL TYPE I ENDOLEAK BUT WITHOUT ANY ANEURYSM GROWTH. THE PHYSICIAN ELECTED TO INTERVENE BY PLACING AN ANEURX 29 MM CUFF PROXIMALLY, WHICH SIGNIFICANTLY REDUCED BUT DID NOT COMPLETELY RESOLVE THE ENDOLEAK. THE PHYSICIAN ELECTED NOT TO INTERVENE FURTHER BUT TO MONITOR THE PATIENT. AT A 1 MONTH CT F/U, THE ENDOLEAK WAS STILL PRESENT. NO FURTHER INTERVENTION HAS OCCURRED OR IS PLANNED. NO ADD'L CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO MIH MEDTRONIC CARDIOVASCULAR NA V00424321

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention