BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT II

    MDR report key: 3771463 · Received April 24, 2014

    Report

    Report Number
    2953200-2014-00834
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    February 18, 2014
    Report Date
    April 22, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, CONCLUSION: (COMPLAINT CONFIRMED, MFG. RELATED).

    Description of Event or Problem · 1

    AN ENDURANT II STENT GRAFT SYSTEM WAS ATTEMPTED, NOT USED FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE AND AFTER OPENING THE MAIN GRAFT AND CATHETERIZATION, IT WAS NOT POSSIBLE TO ENTER THE GUIDE WIRE (ANOTHER MANUFACTURER'S DEVICE) INTO THE CONTRALATERAL DELIVERY SYSTEM. THERE WAS NO DAMAGE TO THE DEVICE OR PACKAGING. THE DEVICE WAS NOT FLUSHED. THE PHYSICIAN USED ANOTHER DEVICE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS DOING FINE. THE DEVICE WAS RETURNED WITHIN AN ENDOVASCULAR RETURN KIT. THE CATALOG AND LOT NUMBERS ON THE RETURNED DOCUMENTS MATCHED THE NUMBERS FROM THE EVENT. THE DELIVERY SYSTEM WAS RETURNED SLIGHTLY BLOODIED WITH THE STENT GRAFT LOADED WITHIN THE DELIVERY SYSTEM. UPON INSPECTION OF THE DEVICE, AN OCCLUSION OF THE TAPERED TIP WAS OBSERVED BY A GLOSSY MATERIAL. THERE WAS A 1 MM GAP BETWEEN THE GRAFT COVER AND TAPERED TIP. THE REST OF THE DEVICE WAS UNREMARKABLE. A GUIDE WIRE WAS ATTEMPTED TO BE INSERTED THROUGH THE TAPERED TIP; HOWEVER, THERE WAS AN OCCLUSION IN THE TAPERED TIP ID AT THE START OF THE LUMEN. THE GUIDE WIRE WAS THEN TRACKED THROUGH THE BACKEND T-TUBE AND THE SAME OCCLUSION WAS MET. ADDITIONAL FORCE WAS APPLIED TO THE OCCLUSION, AND IT WAS EJECTED FROM TAPERED TIP. THE GRAFT COVER WAS RETRACTED SLIGHTLY TO EXPOSE THE TAPERED TIP SHOULDER AND NO MATERIAL WAS OBSERVED. THE COMPLAINT WAS CONFIRMED; THERE WAS AN OBSTRUCTION IN THE TAPERED TIP LUMEN THAT PREVENTED WIRE PASSAGE. THE MATERIAL OCCLUDING THE TAPERED TIP SHOULDER MATCHED HYDROPHILIC COATING (DRY) BY 63%. THE ROOT CAUSE OF THE EVENT IS LIKELY DUE TO HYDROPHILIC COATING ENTERING THE TAPERED TIP LUMEN DURING MANUFACTURING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248954 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04194953

    Patients

    Seq Age Sex Outcome Treatment
    1