BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT STENT GRAFT SYSTEM

    MDR report key: 5654673 · Received May 13, 2016

    Report

    Report Number
    2953200-2016-01032
    Event Type
    Injury
    Date Received
    May 13, 2016
    Date of Event
    December 3, 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.

    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; EVALUATION OF ANEURYSM NECK ANGLE CHANGE AFTER ENDOVASCULAR ANEURYSM REPAIR CLINICAL INVESTIGATIONS. TRONG BINH LE, MI HYOUNG MOON, YONG SUN JEON, KEE CHUN HONG, SOON GU CHO, KEUN-MYOUNG PARK. DOI (B)(4). CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY 39(5) - DECEMBER 2015 ENDURANT STENT GRAFT SYSTEMS WERE IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF ABDOMINAL AORTIC ANEURYSMS BETWEEN DECEMBER 2005 AND JUNE 2014. THE FOLLOWING INFORMATION IS REVIEWED IN THIS JOURNAL ARTICLE: TYPE I ENDOLEAK, TYPE III UNKNOWN ENDOLEAK, TYPE V ENDOLEAK, VASCULAR BYPASS CONVERSION, OCCLUSION. ABSTRACT: TO EVALUATE THE ANEURYSM NECK ANGLE CHANGES AND POST-ENDOVASCULAR ANEURYSM REPAIR (EVAR) COMPLICATIONS. WE RETROSPECTIVELY ANALYZED 72 CASES OF ELECTIVE EVAR FOR ABDOMINAL AORTIC ANEURYSM AMONG 109 CONSECUTIVE CASES FROM DECEMBER 2005 TO APRIL 2014. PATIENTS WERE DIVIDED INTO ANGULATED AND NON-ANGULATED GROUPS. THE ANGULATED GROUP WAS DEFINED AS NECK ANGULATION =60&#2976;NECK ANGLE WAS EVALUATED PRE- AND POST-EVAR DURING SHORT- (WITHIN 1 MONTH), MID- (3-6 MONTHS), AND LONG-TERM (>1 YEAR) FOLLOW-UP. ANEURYSM SAC DIAMETER CHANGE, ANEURYSM NECK MORPHOLOGY OTHER THAN ANGULATION, ENDOLEAKS, AND OTHER POST-PROCEDURAL COMPLICATIONS WERE ALSO DOCUMENTED. A TOTAL OF 34 PATIENTS WERE ENROLLED IN THE ANGULATED GROUP. THERE WERE NO STATISTICAL DIFFERENCES IN AGE, SEX, FOLLOW-UP DURATION, AND ANEURYSM NECK PROFILE BETWEEN THE TWO GROUPS (P > 0.05). BOTH GROUPS SHOWED STATISTICALLY SIGNIFICANT AND CONSISTENT DECREASES IN ANGULATION DURING THE FOLLOW-UP PERIOD (P <(><<)> 0.01). THE ANGULATED GROUP REVEALED 22.45 % MORE STRAIGHTENING THAN THE NON-ANGULATED GROUP. RECOIL OF THE ENDURANT DEVICE OCCURRED IN THE ANGULATED GROUP. NO STATISTICALLY SIGNIFICANT INTERGROUP DIFFERENCES WERE OBSERVED IN ANY ENDOLEAKS, COMPLICATIONS, OR RE-INTERVENTION RATES (P > 0.05). PRE-EVAR ANGLE WAS THE ONLY PREDICTOR FOR POST-PROCEDURAL ANGLE CHANGE (P <(><<)> 0.001). EVAR IS APPLICABLE FOR PATIENTS WITH HIGHLY ANGULATED ANEURYSM NECK AND PROVIDES CONSISTENT NECK STRAIGHTENING OVER LONG-TERM FOLLOW-UP. RECOIL WAS EVIDENT IN THE ANGULATED GROUP USING THE ENDURANT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308947 ENDURANT STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention