BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX STENT GRAFT

    MDR report key: 2323775 · Received November 3, 2011

    Report

    Report Number
    2953200-2011-01894
    Event Type
    Injury
    Date Received
    November 3, 2011
    Date of Event
    August 4, 2011
    Report Date
    October 4, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION, RESULTS: (LACK OF INFORMATION, DETAILS UNKNOWN).

    Description of Event or Problem · 1

    AN ENDURANT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5.5 MM IN DIAMETER ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 2 MONTHS AGO. THE DISTAL AORTA WAS NARROW AND CALCIFIED, AND THE VESSELS HAD MODERATE TORTUOSITY AND MILD CALCIFICATION. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY APPROXIMATELY 1 MONTH POST-IMPLANTATION, AND THE CT DEMONSTRATED A FABRIC-RELATED TEAR (TYPE III ENDOLEAK) AT THE LEVEL OF THE FLOW DIVIDER AND THAT THE ANEURYSM HAD RUPTURED (MFR REPORT #2952200-2011-01517, MFR REPORT #2952200-2011-01518). THE PHYSICIAN BELIEVES THAT THE CAUSE OF THE TYPE III ENDOLEAK IS MOST LIKELY RELATED TO THE NARROW AND CALCIFIED AORTIC BIFURCATION, WHICH MADE IT DIFFICULT TO REMOVE THE TIP OF THE DEVICE. THE PHYSICIAN ELECTED TO CONVERT THE PATIENT TO A PARTIAL OPEN REPAIR AND ONLY REMOVED THE ILIAC LIMB (MFR REPORT #2952200-2011-01519) BEFORE SEWING IN A DACRON GRAFT TO THE BIFURCATED STENT GRAFT; THE TYPE III ENDOLEAK WAS SUCCESSFULLY RESOLVED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE. THE DEVICES WERE RETURNED FOR EVALUATION. AFTER THE EXPLANTED DEVICES WERE OPENED IT WAS NOTED THAT THERE WERE TWO ANEURX DEVICES. EVALUATION SUMMARY: THE RETURNED DEVICES ANALYSIS HAS BEEN COMPLETED. THE STENT GRAFTS WERE REMOVED DURING SURGICAL CONVERSION DUE TO A RUPTURED ABDOMINAL AORTIC ANEURYSM CAUSED BY A TYPE III FABRIC ENDOLEAK. FROM THE EXAMINATION OF THE RETURNED DEVICES AND CLINICAL INFORMATION PROVIDED THE EXACT CAUSE OF THE TYPE III ENDOLEAK, LEADING TO THE RUPTURED ABDOMINAL AORTIC ANEURYSM, COULD NOT BE DETERMINED. A SINGLE 30 MM LENGTH SECTION OF 4 TRANSECTED <(>&<)> ATTACHED STENT GRAFT COMPONENTS WERE RETURNED FOR EVALUATION. THIS RETURNED SECTION CONSISTED OF THE DISTAL SECTION OF THE BIFURCATE GATE (SPRING 7 - 8; APPROXIMATELY 10 MM DISTAL TO THE FLOW DIVIDER) WHICH WAS OBSERVED LINED BY AN ENDURANT CONTRALATERAL LIMB AND 2 ANEURX CUFFS. OTHER THAN AN 8 - 18 MM LENGTH CUT SEEN ACROSS THE MID-LENGTH OF THIS RETURNED SECTION, LIKELY OCCURRING DURING THE SURGICAL CONVERSION, NO OTHER DEVICE INTEGRITY ISSUES WERE OBSERVED. THE SOURCE OF THE TYPE III FABRIC ENDOLEAK WAS REPORTED TO BE AT THE LEVEL OF THE FLOW DIVIDER; PROXIMAL TO THE SECTION OF THE RETURNED EXPLANT. SINCE THE REPORTED FABRIC HOLE COULD NOT BE ANALYZED AND FILMS WERE NOT PROVIDED, THE CAUSE OF THE FABRIC TEAR COULD NOT BE DETERMINED. IT IS POSSIBLE THAT THIS TEAR WAS CAUSED AT IMPLANT BY THE CALCIFICATION WITHIN THE NARROW AORTIC BIFURCATION DURING THE DELIVERY SYSTEM REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Required Intervention