BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 1192583 · Received October 8, 2008

    Report

    Report Number
    2953200-2008-00911
    Event Type
    Injury
    Date Received
    October 8, 2008
    Date of Event
    September 9, 2008
    Report Date
    September 9, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    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

    EVALUATION CODES: RESULTS: ANOTHER MANUFACTURER'S BALLOON. ENDOLEAK, RUPTURED VESSEL. CONCLUSION: ANOTHER MANUFACTURER'S BALLOON.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED FOR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM MORPHOLOGY WAS NOT REPORTED. VESSEL MORPHOLOGY WAS REPORTED AS NO TORTUOSITY AND MILD CALCIUM. IT WAS REPORTED THAT THE BIFURCATED STENT GRAFT WAS IMPLANTED AND THEN THE CONTRALATERAL LIMB WAS IMPLANTED. UPON FINAL ANGIOGRAM, THERE WAS A TYPE 1 ENDOLEAK AT THE PROXIMAL END OF THE BIFURCATED STENT GRAFT. AN AORTIC CUFF WAS PLACED TO TREAT THE PROXIMAL TYPE 1 ENDOLEAK. A SECOND TYPE I ENDOLEAK WAS DISCOVERED AFTER PLACEMENT OF THE CUFF. THE PHYSICIAN ELECTED TO BALLOON THE CUFF USING ANOTHER MANUFACTURER'S BALLOON. UPON INFLATION OF THE BALLOON, THE VESSEL WALL WAS PERFORATED APPROXIMATELY 25 MM BELOW THE RENAL ARTERY. THE BALLOON WAS INFLATED WITHIN THE BIFURCATED SECTION OF THE STENT GRAFT. THE PHYSICIAN ELECTED TO PLACE TWO AORTIC CUFFS FROM ANOTHER MANUFACTURER TO THE RENAL ARTERY. NO ADDITIONAL 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 MIH MEDTRONIC CARDIOVASCULAR NA V00100087

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention