BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDURANT AUI STENT GRAFT SYSTEM

    MDR report key: 2223173 · Received August 12, 2011

    Report

    Report Number
    2953200-2011-01428
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 13, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: (DEPLOYMENT DIFFICULTIES). EVAL SUMMARY: THE STENT GRAFT HAD BEEN DEPLOYED IN THE CASE. THE TIP WAS RECAPTURED WITHIN THE GRAFT COVER. THE SPINDLE WAS RECAPTURED INTO OTHER SLEEVE. THERE WERE OTHER KINKS ON THE SHEATH AT 4.5, 7.5 AND 10CM FROM THE EDGE OF THE GRAFT COVER. THE SLIDER WAS IN THE HOME POSITION. THE BACKEND WHEEL WAS ROTATED TO THE BOTTOM OF THE SCREW GEAR IN THE RECAPTURE POSITION. DURING EVAL, THE STENT GRAFT AND SPINDLE DEPLOYMENT MECHANISM OPERATED FINE WITHOUT ISSUES. THE EVAL OF THE RETURNED DELIVERY SYSTEM COULD NOT DETERMINE A CAUSE FOR THE REMOVAL DIFFICULTIES; NO PERFORMANCE OR MFG ISSUES WERE IDENTIFIED.

    Description of Event or Problem · 1

    AN ENDURANT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM OF AN UNK SIZE. THE VESSELS WERE NOT TORTUOUS, AND VESSEL CALCIFICATION IS UNK. IT WAS REPORTED THAT THE DELIVERY SYSTEM WAS INSERTED VIA THE LEFT SIDE. THE DEVICE WAS POSITIONED AT THE LOWEST RENAL ARTERY AND THE EXTERNAL SLIDER WAS ROTATED ALONG THE SCREW GEAR. THE BACKEND WHEEL WAS ROTATED ALONG THE BACKEND SCREW GEAR; HOWEVER, NOT ALL OF THE SUPRARENAL STENTS STRUTS DISENGAGED FROM THE SPINDLE AS NORMAL. THE PHYSICIAN ELECTED TO INTERVENE BY FIRST INFLATING A PTA BALLOON INSIDE THE STENTS TO TRY AND DISENGAGE THE STENTS; HOWEVER, THIS WAS INEFFECTIVE. THEN, A RELIANT BALLOON CATHETER WAS USED IN THE SAME MANNER, AND THE STRUTS SPRANG OPEN. THE DELIVERY SYSTEM WAS THEN WITHDRAWN AS PER THE IFU, AND THE PROCEDURE WAS CONCLUDED. NO CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE. THE DEVICE HAS BEEN RECEIVED BY MEDTRONIC, AND THE ANALYSIS HAS BEEN COMPLETED. PLEASE NOTE THAT THIS DEVICE (B)(4) IS DISTRIBUTED OUTSIDE THE UNITED STATES; HOWEVER, IT IS SIMILAR OT THE UNITED STATED DISTRIBUTED PRODUCT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT AUI STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00882584

    Patients

    Seq Age Sex Outcome Treatment
    1