BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO

    MDR report key: 1884027 · Received October 14, 2010

    Report

    Report Number
    2953200-2010-01959
    Event Type
    Injury
    Date Received
    October 14, 2010
    Date of Event
    September 14, 2010
    Report Date
    September 14, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVAL RESULTS: ENDOLEAK, ARTERIAL TRAUMA/DISSECTION/PERFORATION; AGGRESSIVE BALLOONING; ANOTHER MFR'S BALLOON. CONCLUSION: AGGRESSIVE BALLOONING; ANOTHER MFR'S BALLOON.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5.7 CM ABDOMINAL AORTIC ANEURYSM. THE AORTIC NECK WAS 22-25 MM IN DIAMETER, 30 MM LONG, MODERATELY ANGULATED, AND HAD MILD THROMBUS. THE ILIAC ARTERIES HAD MILD CALCIFICATION AND WERE ANEURYSMAL. IT WAS REPORTED THAT DURING THE DEPLOYMENT OF THE MAIN TALENT BODY (MFR REPORT # 2953200-2010-01958), THE STENT GRAFT SLIPPED DISTALLY ABOUT 1 CM BELOW THE RENAL ARTERIES, RESULTING IN A PROXIMAL TYPE I ENDOLEAK; THE INACCURATE DELIVERY SEEMED TO BE DUE TO USER TECHNIQUE RATHER THAN THE ANATOMY. THE PHYSICIAN ELECTED TO INTERVENE BY PLACING A TALENT CUFF PROXIMALLY; HOWEVER, THE ENDOLEAK DID NOT RESOLVE. THE PHYSICIAN WAS BALLOONING AGGRESSIVELY WITH ANOTHER MFR'S BALLOON ENTIRELY INSIDE THE CUFF, AND THEN THE AORTA RUPTURED. THE BALLOONING WAS LIKELY PRESSING AGAINST SOME OF THE BARE SPRINGS OF THE BIFURCATED GRAFT VIA THE CUFF. THE PHYSICIAN ELECTED TO IMPLANT TWO MORE TALENT CUFFS PROXIMALLY, AND ONE OF THEM (MFR REPORT # 2953200-2010-01960) WAS PLACED TO INTENTIONALLY COVER THE LEFT RENAL ARTERY IN ORDER TO GET A GOOD SEAL. NO FURTHER INTERVENTION WAS DONE, AND THE RIGHT RENAL WAS PATENT. NO ADD'L CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00417767

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention