BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT II

    MDR report key: 4132850 · Received October 1, 2014

    Report

    Report Number
    2953200-2014-01961
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 5, 2014
    Report Date
    October 28, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MFG RELATED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY WAS NOT REPORTED. I WAS REPORTED THAT WHILE PREPPING THE DEVICE THE PHYSICIAN WAS UNABLE TO FLUSH THE DEVICE. IN ADDITION, THE WIRE WAS UNABLE TO PASS THROUGH THE TAPER TIP. THE PHYSICIAN NOTED THAT THE TAPER TIP OF THE DELIVERY SYSTEM WAS OCCLUDED. THE PHYSICIAN DECIDED TO CUT THE TIP OF THE DELIVERY SYSTEM AND PROCEED WITH THE CASE. OTHER OPTIONS WERE GIVEN TO THE PHYSICIAN TO USE OTHER DEVICES; HOWEVER, THE PHYSICIAN CONTINUED WITH THE ALTERED DEVICE. THE STENT GRAFT WAS IMPLANTED SUCCESSFULLY WITHOUT ANY INJURES TO THE PATIENT. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS DOING FINE.

    Description of Event or Problem · 1

    DEVICE ANALYSIS IS AS FOLLOWS. UPON INSPECTION OF THE DELIVERY SYSTEM, APPROXIMATELY 6 MM OF THE DISTAL TIP WAS CUT FROM THE TAPERED TIP AND RETURNED WITHIN A SEALED CONTAINER. THE GRAFT COVER OF THE DELIVERY SYSTEM HAD MULTIPLE KINKS, WHICH IS TYPICAL AFTER USE. A PIECE OF RED PLASTIC WAS DISCOVERED LODGED UNDERNEATH THE QUICK RELEASE TRIGGER. THE REST OF THE DEVICE WAS UNREMARKABLE. MICROSCOPIC IMAGES OF THE CUT DISTAL TIP REVEALED THAT A HARD, GLOSSY AND SEMI-TRANSPARENT MATERIAL OCCLUDED THE TAPERED TIP LUMEN. THE COMPLAINT WAS CONFIRMED; THERE WAS AN OBSTRUCTION AT THE DISTAL END OF THE TAPERED TIP LUMEN. THE CAUSE OF THE OBSTRUCTION WAS DUE TO HYDROPHILIC COATING ENTERING 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
    612763 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04672378

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR