BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT IIS STENT GRAFT

    MDR report key: 7047879 · Received November 21, 2017

    Report

    Report Number
    2953200-2017-01824
    Event Type
    Injury
    Date Received
    November 21, 2017
    Date of Event
    March 15, 2017
    Report Date
    November 21, 2017
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; REINTERVENTION RATE AFTER OPEN SURGERY AND ENDOVASCULAR REPAIR FOR NONRUPTURED ABDOMINAL AORTIC ANEURYSMS DEOKBI HWANG, SUJIN PARK, HYUNG-KEE KIM, JONG-MIN LEE, AND SEUNG HUH (ANN VASC SURG 2017; 43: 134¿143) HTTPS://DOI.ORG/10.1016/J.AVSG.2017.03.168 FDC 24 UNFAVORABLE MORPHOLOGY OF THE ANEURYSM

    Description of Event or Problem · 1

    AN ENDURANT II(S) STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF ABDOMINAL AND/OR ILIAC ARTERY ANEURYSM REPAIR. THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: ENDOLEAKS (TYPE IA, TYPE IB, TYPE III), DEATH ( NON - ANEURYSM RELATED) BACKGROUND: WE AIM TO DETERMINE THE REINTERVENTION RATE AFTER OPEN AORTIC ANEURYSM REPAIR (OAR) OR ENDOVASCULAR ANEURYSM REPAIR (EVAR) ACCORDING TO COMPLIANCE OR NONCOMPLIANCE WITH THE INSTRUCTIONS FOR USE (IFU) FOR COMMERCIAL ENDOVASCULAR STENT GRAFTS. METHODS: AFTER EXCLUSION OF THOSE WITH A RUPTURED ABDOMINAL AORTIC ANEURYSM (AAA) AND ISOLATED ILIAC ARTERY ANEURYSM WITH OR WITHOUT A SMALL AAA (DIAMETER <(><<)> 5 CM), 240 PATIENTS RECEIVED OAR OR EVAR FOR A NONRUPTURED AAA BETWEEN JANUARY 2006 AND MARCH 2016. EVAR WAS PERFORMED FROM OCTOBER 2009. PATIENTS WERE DIVIDED INTO 3 GROUPS: OAR (N ¼ 146), IFU EVAR (N ¼ 42), AND NON-IFU EVAR (N ¼ 52). REINTERVENTION WAS DEFINED AS GRAFT-RELATED OR LAPAROTOMY-RELATED (WITH AN ABDOMINAL INCISION AFTER INITIAL LAPAROTOMY) REOPERATIONS EITHER DURING THE INDEX ADMISSION PERIOD OR LATER. FINAL ENDOLEAK AFTER EVAR WAS DEFINED AS PERSISTENT TYPE I OR III ENDOLEAK BEFORE EXITING OPERATING ROOM AFTER VARIOUS PROCEDURES TO ELIMINATE THE ENDOLEAK. RESULTS: THERE WERE 2 IN-HOSPITAL DEATHS IN THE OAR GROUP CAUSED BY REPERFUSION INJURY OR PANCREATITIS. THERE WAS NO IN-HOSPITAL MORTALITY IN THE EVAR GROUP. FINAL ENDOLEAK WAS MORE COMMON IN NON-IFU EVAR COMPARED WITH IFU EVAR (17% VS. 0%; P ¼ 0.004). THE MEAN FOLLOW-UP DURATION WAS 42.1 MONTHS, 25.3 MONTHS, AND 25.0 MONTHS IN THE OAR, IFU EVAR, AND NON-IFU EVAR GROUPS, RESPECTIVELY. RESPECTIVE REINTERVENTION-FREE SURVIVAL (RFS) RATES AT 1 AND 3 YEARS DIFFERED SIGNIFICANTLY BY GROUP: 97% AND 95% IN THE OAR GROUP, 100% AND 96% IN THE IFU EVAR GROUP, AND 89% AND 87% FOR NON-IFU EVAR GROUP (P ¼ 0.043) WITH A HIGHER REINTERVENTION RATE IN THE NON-IFU EVAR THAN IN THE OAR GROUP. THERE WAS NO SIGNIFICANT DIFFERENCE IN RFS RATE BETWEEN THE OAR AND IFU EVAR GROUPS (P ¼ 0.881). OVERALL SURVIVAL (OS) RATES AT 1 AND 3 YEARS, RESPECTIVELY, WERE 94% AND 78% IN THE OAR GROUP, 90% AND 86% IN THE IFU EVAR GROUP, AND 93% AND 56% IN THE NON-IFU EVAR GROUP (P ¼ 0.098). THERE WERE NO SIGNIFICANT DIFFERENCES BETWEEN THE OAR AND IFU EVAR GROUPS (P¼ 0.890). CONCLUSIONS: IN CONTRAST TO IFU EVAR GROUP, THE RFS AND OS RATES OF NON-IFU EVAR GROUP WERE LOWER THAN IN THE OAR GROUP DURING MID-TERM FOLLOW-UP. FINAL ENDOLEAK WAS MORE FREQUENT, AND REINTERVENTION WAS MORE COMMONLY PERFORMED IN THE NON-IFU GROUP THAN IN THE IFU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830771 ENDURANT IIS STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention