BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 3083444 · Received April 29, 2013

    Report

    Report Number
    2953200-2013-00804
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    June 23, 2017
    Report Date
    June 30, 2017
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (OCCLUSION); PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (ANATOMY RELATED). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (ANATOMY RELATED).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION REPORTED THAT THE PATIENT PRESENTED WITH RIGHT ACUTE LIMB ISCHEMIA. THE PATIENT PROCEEDED TO SURGERY FOR "LEFT TO RIGHT FEM-FEM CROSS OVER AND RIGHT FEMORAL THROMBECTOMY. THE INVESTIGATOR ASSESSED THE EVENT AS DEVICE RELATED AND NOT PROCEDURE RELATED. THE EVENT WAS RESOLVED AND THE PATIENT WAS DISCHARGED HOME 5 DAYS LATER. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE TREATMENT OF A 5.5 CM FUSIFORM ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY WAS REPORTED AS THE INFRARENAL AORTIC NECK HAD AN ANGLE OF 55 DEGREES. THE RIGHT ILIAC ARTERIES WERE MODERATELY TORTUOUS AND THE LEFT ILIAC WAS MILDLY TORTUOUS. THE LEFT ILIAC ARTERY WAS 14 MM TO 20 MM IN DIAMETER. IT WAS REPORTED THAT FIVE DAYS POST STENT GRAFT IMPLANT THERE WAS THE ANEURYSM WAS 5.7 CM IN DIAMETER WITH NO TECHNICAL OBSERVATIONS. HOWEVER THERE WAS STENT GRAFT STENOSIS IN THE LEFT ILIAC STENT GRAFT. FOUR MONTH LATER AN ULTRASOUND REVEALED THAT THE ANEURYSM WAS 5.2 CM IN DIAMETER. THERE IS A TECHNICAL OBSERVATION THAT THERE IS KINKING IN THE LEFT ILIAC STENT GRAFT LIMB. THE ONE YEAR FOLLOW UP CT REVEALED THAT THE ANEURYSM WAS 5.4 CM IN DIAMETER WITH A TECHNICAL OBSERVATION. THERE WAS STENT GRAFT STENOSIS IN THE RIGHT ILIAC LIMB DUE TO NON-SIGNIFICANT THROMBOSIS PRESENT. THERE WERE WAS NO TREATMENT OR INTERVENTION. THE 30 MONTH FOLLOW UP ULTRASOUND THAT REVEALED THAT THERE WAS THROMBUS ASSOCIATED WITH DISTAL ASPECT OF RIGHT ILIAC LIMB. NOT HEMODYNAMICALLY SIGNIFICANT. THERE WERE WAS NO TREATMENT OR INTERVENTION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185655 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA V00328341

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Required Intervention