BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO

    MDR report key: 2230648 · Received August 12, 2011

    Report

    Report Number
    2953200-2011-01427
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 13, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS OF EVAL: (ENDOLEAK), (DISEASE PROGRESSION, SHORT AND DILATED AORTIC NECK). CONCLUSION: (DISEASE PROGRESSION, SHORT AND DILATED AORTIC NECK).

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A 5 CM IN DIAMETER ABDOMINAL AORTIC ANEURYSM APPROX 8.5 YRS AGO. THE AORTIC NECK WAS SHORT AND CONICAL IN SHAPE. IT WAS REPORTED THAT AT A CT PERFORMED APPROX 50 MONTHS POST-IMPLANT, IT WAS NOTED THAT THERE MAY HAVE BEEN A TYPE I ENDOLEAK (MFR REPORT # 2953200-2007-00394). THE ANEURYSM WAS 5.2 CM IN DIAMETER, AND THERE WAS EXTENSIVE MURAL THROMBUS AND SOME CONTRAST WITHIN THE ANEURYSM SAC. THE ILIAC LIMBS WERE PATENT. APPROX 7 YRS POST-IMPLANT, THE PHYSICIAN ELECTED TO INTERVENE BY FIRST PLACING A RENAL STENT VIA THE ARM AND THEN IMPLANTING A TALENT CONVERTER AND A TALENT AORTIC CUFF (MFR REPORT # 2953200-2011-01427) OVER THE RENAL STENT TO ACHIEVE A PROXIMAL SEAL SUCCESSFULLY, FOLLOWED BY PERFORMING A FEMORAL-FEMORAL BYPASS. APPROX 1 MONTH AGO, IT WAS NOTED THAT THERE WAS A PROXIMAL TYPE I ENDOLEAK AND THAT THE ANEURYSM WAS 7.2 CM IN DIAMETER. THE AORTIC NECK WAS LESS THAN 1 CM LONG AND 25 - 26.5 MM IN DIAMETER. THE ENDOLEAK WAS ATTRIBUTED TO THE SHORT AND DILATED AORTIC NECK AND DISEASE PROGRESSION. THE PT IS NOT A SURGICAL CANDIDATE. THE PHYSICIAN ELECTED TO INTERVENE BY PLACING A CUFF PROXIMALLY, WHICH SUCCESSFULLY RESOLVED THE ENDOLEAK. 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 V00231691

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention