BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX

    MDR report key: 3162576 · Received June 11, 2013

    Report

    Report Number
    2953200-2013-01100
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    January 4, 2012
    Report Date
    May 14, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: ENDOLEAK, REMOVAL OF IMPLANT. ANATOMY RELATED: RUPTURED ABDOMINAL AORTIC ANEURYSM. TREATMENT OF A RUPTURED ABDOMINAL AORTIC ANEURYSM. CONCLUSION: ANATOMY RELATED: RUPTURED ABDOMINAL AORTIC ANEURYSM. TREATMENT OF A RUPTURED ABDOMINAL AORTIC ANEURYSM.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 10 CM IN DIAMETER RUPTURED ABDOMINAL AORTIC ANEURYSM. THE VESSEL MORPHOLOGY WAS UNREMARKABLE WITH NO MORPHOLOGICAL CHANGES IN THE VESSELS FROM THE TIME OF IMPLANT. IT WAS REPORTED THAT A RECENT CT REVEALED THAT THERE WAS A TYPE III ENDOLEAK, FABRIC OF THE STENT GRAFT. THE PHYSICIAN ELECTED TO EXPLANT THE DEVICE. NO FURTHER INFORMATION IS AVAILABLE FOR THIS CASE. THE PATIENT SURGICALLY CONVERTED TO A CONVENTIONAL GRAFT. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262535 ANEURX SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00807391

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Required Intervention