BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II

    MDR report key: 6983273 · Received October 27, 2017

    Report

    Report Number
    2953200-2017-01648
    Event Type
    Injury
    Date Received
    October 27, 2017
    Date of Event
    July 24, 2017
    Report Date
    October 27, 2017
    Manufacturer
    MEDTRONIC CARIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL ARTICLE DETAILS TITLE: A PROPENSITY SCORE¿MATCHED ANALYSIS OF INFLAMMATORY RESPONSE WITH ENDOVASCULAR ANEURYSM SEALING VS ENDOVASCULAR ANEURYSM REPAIR AUTHORS; PATRICK BERG, MD, ROLAND A. STROETGES, MD, LARRY E. MILLER, PHD, AND JOCHEN SCHOEFFERLE JOURNAL OF ENDOVASCULAR THERAPY 2017, VOL. 24(5) 670¿674 DOI: HTTPS://DOI.ORG/10.1177/1526602817722019. 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 A JOURNAL ARTICLE: AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED INTO A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. EVENTS REPORTED IN THE JOURNAL ARTICLE. TYPE II ENDOLEAK WITH INTERVENTION, INFLAMMATORY RESPONSE, POST IMPLANTATION SYNDROME. ABSTRACT PURPOSE: TO EVALUATE THE RISK OF POSTIMPLANTATION SYNDROME ASSOCIATED WITH ENDOVASCULAR ANEURYSM SEALING (EVAS) AND ENDOVASCULAR ANEURYSM REPAIR (EVAR) IN PATIENTS TREATED FOR ABDOMINAL AORTIC ANEURYSM (AAA). METHODS: FROM DECEMBER 2013 TO MAY 2015, 41 AAA PATIENTS TREATED WITH EVAS (MEAN AGE 72±9 YEARS; 38 MEN) AND 63 WITH EVAR (MEAN AGE 74±10 YEARS; 55 MEN) AT A SINGLE CENTER WERE RETROSPECTIVELY REVIEWED. MDT ENDURANT STENT GRAFTS USED IN STUDY. TO CONTROL FOR TREATMENT SELECTION BIAS, PROPENSITY SCORE MATCHING WAS USED TO COMPARE OUTCOMES BY TREATMENT MODE. MAIN OUTCOMES WERE POSTIMPLANTATION SYNDROME (DEFINED AS TEMPERATURE >38°C AND LEUKOCYTE COUNT >12,000/L), INFLAMMATORY RESPONSE MARKERS [PLATELETS AND HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP)], AND CLINICAL COMPLICATIONS THROUGH 30 DAY (TO INCLUDE TYPE I AND II ENDOLEAKS AND MORTALITY). RESULTS: IN 39 MATCHED PATIENTS PER GROUP, THE INCIDENCES OF POSTIMPLANTATION SYNDROME (P=0.07), MEAN BODY TEMPERATURE (P=0.05), MEAN LEUKOCYTE COUNT (P=0.003), AND MEAN HS-CRP (P<(><<)>0.001) WERE PROPORTIONALLY LOWER WITH EVAS VS EVAR. SERIOUS ADVERSE EVENTS (0% VS 12.8%, P=0.05) AND ENDOLEAKS (0% VS 10.3%, P=0.13) THROUGH 30 DAYS WERE LESS FREQUENT WITH EVAS, BUT THE GROUP DIFFERENCES WERE NOT SIGNIFICANTLY DIFFERENT. THE CHOICE OF ENDOVASCULAR GRAFT MATERIAL INFLUENCED POSTOPERATIVE AND 30-DAY CLINICAL OUTCOMES, WITH GREATER OVERALL RISK OBSERVED WITH POLYESTER STENT-GRAFTS (INCLUSIVE OF MDT ENDURANT GRAFTS). CONCLUSION: ENDOVASCULAR ANEURYSM SEALING IS ASSOCIATED WITH A BLUNTED SYSTEMATIC INFLAMMATORY RESPONSE COMPARED WITH EVAR. POLYESTER STENT-GRAFTS (ENDURANT) INDUCE THE GREATEST PERIPROCEDURAL INFLAMMATORY RESPONSE. IN PATIENTS THAT HAD ENDURANT IMPLANTED, NO DEATHS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763382 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention