BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT STENT GRAFT SYSTEM

    MDR report key: 5654646 · Received May 13, 2016

    Report

    Report Number
    2953200-2016-01029
    Event Type
    Injury
    Date Received
    May 13, 2016
    Date of Event
    July 10, 2015
    Report Date
    May 2, 2016
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT DATES OF THE EVENTS ARE UNKNOWN. (B)(4). A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: SEX. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; ANATOMICAL FEATURES AND EARLY OUTCOMES OF ENDOVASCULAR REPAIR OF ABDOMINAL AORTIC ANEURYSM FROM A KOREAN MULTICENTER REGISTRY. HYUNWOOK KWON, DO YUN LEE, SOO JIN NA CHOI, KI HYUK PARK, SEUNG-KEE MIN, JEONG-HWAN CHANG, SEUNG HUH, YONG SUN JEON, JEHWAN WON, SEUNG JAE BYUN10, SANG JUN PARK, LEE CHAN JANG, AND TAE-WON KWON, KOREA AN ANEURX, TALENT AND ENDURANT STENT GRAFT SYSTEMS WERE IMPLANTED IN PATIENTS FOR THE TREATMENT OF ENDOVASCULAR ANEURYSM REPAIR. DURING THE RETROSPECTIVE STUDY THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: LIMB ISCHEMIA, OCCLUSION, MI, PNEUMONIA, BOWEL ISCHEMIA, RENAL FAILURE, BLEEDING, TYPE IA, TYPE IB, TYPE II, TYPE III, TYPE IV, FEVER, DEATH (UNKNOWN CAUSE) PURPOSE: TO INTRODUCE A NATION-BASED ENDOVASCULAR ANEURYSM REPAIR (EVAR) REGISTRY IN SOUTH KOREA AND TO ANALYZE THE ANATOMICAL FEATURES AND EARLY CLINICAL OUTCOMES OF ABDOMINAL AORTIC ANEURYSMS (AAA) IN PATIENTS WHO UNDERWENT EVAR. MATERIALS AND METHODS: THE KOREAN EVAR REGISTRY (KER) WAS A TEMPLATE-BASED ONLINE REGISTRY DEVELOPED AND ESTABLISHED IN 2009. THE KE R RECRUITED 389 PATIENTS WHO UNDERWENT EVAR FROM 13 MEDICAL CENTERS IN (B)(6) FROM JANUARY 2010 TO JUNE 2010. WE RETROSPECTIVELY REVIEWED THE ANATOMIC FEATURES AND 30-DAY CLINICAL OUTCOMES. RESULTS: INITIAL DEPLOYMENT WITHOUT OPEN CONVERSION WAS ACHIEVED IN ALL CASES AND PROCEDURE-RELATED 30-DAY MORTALITY RATE WAS 1.9%. ANATOMIC FEATURES SHOWED THE FOLLOWING VARIABLES: PROXIMAL AORTIC NECK ANGLE 48.8±25.7O (MEAN±STANDARD DEVIATION), VERTICAL NECK LENGTH 35.0±17.2 MM, ANEURYSMAL SAC DIAMETER 57.2±14.2 MM, COMMON ILIAC ARTERY (CIA) INVOLVEMENT IN 218 (56.3%) PATIENTS, AND MEDIAN RIGHT CIA LENGTH 34.9 MM. TWO HUNDRED AND NINETEEN (56.3%) PATIENTS SHOWED NECK CALCIFICATION, 98 PATIENTS (25.2%) HAD NECK THROMBUS, AND THE INFERIOR MESENTERIC ARTERIES OF 91 PATIENTS (23.4%) WERE OCCLUDED. CONCLUSION: ANATOMICAL FEATURES OF AAA IN PATIENTS FROM THE KER WERE CHARACTERIZED AS HAVING ANGULATED PROXIMAL NECK, TORTUOUS ILIAC ARTERY, AND A HIGHER RATE OF CIA INVOLVEMENT. LONG-TERM FOLLOW-UP AND ONGOING STUDIES ARE REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309119 ENDURANT STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention