BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT BIFUR XCELERANT - HYDRO (US)

    MDR report key: 1933716 · Received December 16, 2010

    Report

    Report Number
    2953200-2010-02579
    Event Type
    Injury
    Date Received
    December 16, 2010
    Date of Event
    November 19, 2010
    Report Date
    November 19, 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
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL RESULTS: (ENDOLEAK). EVAL RESULTS & CONCLUSION: (CALCIFIED AORTIC NECK AND SMALL FLOW LUMEN).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A 5.5 CM ABDOMINAL AORTIC ANEURYSM. THE AORTIC NECK WAS 13 MM IN LENGTH AND IT WAS CALCIFIED. THE AORTIC BIFURCATION HAD A SMALL FLOW LUMEN AND THE ILIAC ARTERIES AND ACCESS ARTERIES WERE CALCIFIED. IT WAS REPORTED THAT AFTER THE BIFURCATED STENT GRAFT WAS IMPLANTED, THERE WAS A PROXIMAL TYPE 1 ENDOLEAK ON THE RIGHT SIDE. THE DECISION WAS MADE TO PLACE AN ANEURX CUFF PROXIMALLY; HOWEVER, AFTER THE CUFF WAS DEPLOYED AND DURING THE DELIVERY SYSTEM REMOVAL, THE TAPERED TIP GOT CAUGHT ON THE PROXIMAL BARE SPRING OF THE BIFURCATED STENT GRAFT AND BOTH THE BIFUR AND THE CUFF WERE PULLED DOWN APPROX 10 MM (SEE MFR # 2953200-2010-02580). THE PHYSICIAN WAS ABLE TO REMOVE THE DELIVERY SYSTEM WITHOUT FURTHER ISSUE. THE CUFF HAD 3 MM OF APPOSITION IN THE NECK, AND THERE WAS STILL A PROXIMAL TYPE 1 ENDOLEAK. BECAUSE THE PT HAD A LOT OF CONTRAST DURING THE PROCEDURE, THE DECISION WAS MADE TO NOT FURTHER INTERVENE AT THE MOMENT AND TO BRING THE PT BACK AT A LATER DATE TO PLACE A CUFF; HOWEVER, IT IS UNK IF THE PT RETURNED FOR THIS INTERVENTION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT BIFUR XCELERANT - HYDRO (US) MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00505089

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Required Intervention