BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT II

    MDR report key: 4152897 · Received October 8, 2014

    Report

    Report Number
    2953200-2014-02007
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 15, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AN ENDURANT II STENT GRAFT SYSTEM WAS SCHEDULED FOR IMPLANT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY IS UNKNOWN. IT WAS REPORTED THAT THE PHYSICIAN PREPARED TO IMPLANT THE STENT GRAFT. THE PATIENT HAD PRESENTED EMERGENTLY WITH A RUPTURED ANEURYSM. DURING THE PREPARATIONS TO IMPLANT THE GRAFT, IT WAS NOTED THAT THE DEVICE WOULD NOT FLUSH, AND THE TIP APPEARED DAMAGED. THE GRAFT WAS NOT USED, AND ANOTHER GRAFT WAS USED TO COMPLETE THE PROCEDURE. THE DAMAGED DEVICE NEVER TOUCHED THE PATIENT. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. THE DEVICE WAS RETURNED FOR ANALYSIS. MICROSCOPIC IMAGES REVEALED THAT A HARD, GLOSSY AND SEMI-TRANSPARENT MATERIAL WAS OCCLUDED THE TAPERED TIP LUMEN, WHICH IS MOST LIKELY HYDROPHILIC COATING. THE COMPLAINT WAS CONFIRMED; THERE WAS AN OBSTRUCTION IN THE TAPERED TIP LUMEN. THE ROOT CAUSE OF THE EVENT WAS MOST LIKELY MANUFACTURING RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631138 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04672447

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR