BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2953200-2018-01139

    MDR report key: 7756038 · Received August 7, 2018

    Report

    Report Number
    2953200-2018-01139
    Event Type
    Injury
    Date Received
    August 7, 2018
    Date of Event
    July 15, 2018
    Report Date
    November 20, 2018
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 110MM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT, APPROXIMATELY 2 YEARS POST INDEX PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH LOWER ABDOMEN PAIN AND SWELLING. CT SCAN INDICATED A TYPE III ENDOLEAK. THE PATIENT RECEIVED INTERVENTION WITH THE IMPLANTATION OF AN AUI AND A FEM-FEM BYPASS. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT IS UNKNOWN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT WILL BE MONITORED.

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R