BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 3120767 · Received May 20, 2013

    Report

    Report Number
    2953200-2013-00935
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 24, 2013
    Report Date
    April 24, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INACCURATE STENT GRAFT DEPLOYMENT, VESSEL OCCLUSION. SUPRA-RENAL STENTS WERE UNINTENTIONALLY OPENED DUE TO CARDIAC BEAT. UNKNOWN CAUSE OF EVENT. CONCLUSION: SUPRA-RENAL STENTS WERE UNINTENTIONALLY OPENED DUE TO CARDIAC BEAT. AORTIC NECK ANGULATION WAS 100 DEGREES 68 OTHER (UNKNOWN CAUSE OF EVENT).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A FUSIFORM ABDOMINAL AORTIC ANEURYSM. MEDICAL HISTORY IS UNKNOWN. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT WAS REPORTED AS THE INFRA-RENAL ANGULATION WAS 100 DEGREES. THE TERMINAL AORTA WAS AS NARROW AS 15MM AND THE RIGHT AND THE LEFT EIAS WERE NON- TORTUOUS. THE INNER CAVITY OF THE AAA WAS SMALL. THE PROXIMAL NECK DIAMETER BELOW THE RENAL ARTERIES WAS 29MM AND THE DISTAL NECK DIAMETER ABOVE THE ANEURYSM WAS 23MM. THE LENGTH OF THE AORTIC NECK WAS 47MM. THE PROXIMAL NECK DIAMETER OF THE RIGHT ILIAC ARTERY WAS 18MM AND THE DISTAL NECK DIAMETER OF THE RIGHT ILIAC ARTERY WAS 13MM. THE PROXIMAL NECK DIAMETER OF THE LEFT ILIAC ARTERY WAS 19MM AND THE DISTAL NECK DIAMETER OF THE LEFT ILIAC ARTERY WAS 15MM. THE LENGTH OF THE ANEURYSM WAS 85MM. THE LENGTH OF PORTION OF THE RIGHT ILIAC WAS 25MM AND THE LENGTH PORTION OF THE LEFT ILIAC ARTERY WAS 30MM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY FOR AN IMPENDING RUPTURED AAA. WHILE THE PHYSICIAN DEPLOYED SUPRA-RENAL STENTS, THE SUPRA-RENAL STENTS WERE UNINTENTIONALLY OPENED DUE TO CARDIAC BEAT. AFTER THAT, AN ANGIO REVEALED THAT THE PROXIMAL EDGE OF THE MAIN BODY PARTIALLY OCCLUDED THE LOWER LEFT RENAL ARTERY. THERE WAS LITTLE BLOOD FLOW. THE PHYSICIAN CONFIRMED PATIENT'S URINE AND HE DIDN¿T IMPLANT A RENAL STENT. AFTER THAT, THE PHYSICIAN TRIED TO CANNULATE FROM THE CONTRALATERAL SIDE, HOWEVER, THE GUIDE WIRE COULDN¿T PASS THE CONTRALATERAL GATE AND THE PHYSICIAN GAVE UP IMPLANTING THE CONTRALATERAL LIMB. THE PHYSICIAN IMPLANTED THE ENDURANT STENT GRAFT LIKE AUI-FORM AND PERFORMED F-F BYPASS. THERE WAS NO ENDOLEAK. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PHYSICIAN DIDN¿T OCCLUDE THE CONTRALATERAL LEG. PATIENT IS DOING FINE. NO CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222573 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V03028108

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR Required Intervention