BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT AAA STENT GRAFT

    MDR report key: 6899926 · Received September 28, 2017

    Report

    Report Number
    2953200-2017-01507
    Event Type
    Injury
    Date Received
    September 28, 2017
    Date of Event
    June 2, 2017
    Report Date
    September 5, 2017
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL DOI: HTTP://DX.DOI.ORG/10.1016/J.JVS.2017.05.118.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED: ¿POSTOPERATIVE INITIAL 2-DAY BLOOD PRESSURE MANAGEMENT FACILITATES THE SHRINKAGE OF ABDOMINAL AORTIC ANEURYSM AFTER ENDOVASCULAR ANEURYSM REPAIR BY REDUCING THE INCIDENCE OF TYPE II ENDOLEAK.¿ THE FOLLOWING ADVERSE EVENTS WERE REPORTED: TYPE I ENDOLEAK, TYPE III ENDOLEAK, SEVERE RENAL DYSFUNCTION, HEMODIALYSIS, OCCLUSION OF BILATERAL INTERNAL ILIAC ARTERIES, SEVERE ARTERIOSCLEROSIS OBLITERANS. OBJECTIVE: THE AIM OF THIS STUDY WAS TO EVALUATE THE EFFECT OF INITIAL 2-DAY BLOOD PRESSURE MANAGEMENT (BPM) AFTER ENDOVASCULAR ANEURYSM REPAIR (EVAR) FOR THE INCIDENCE OF SUBSEQUENT TYPE II ENDOLEAK (T2E) AND SHRINKAGE OF ABDOMINAL AORTIC ANEURYSM (AAA) SAC DIAMETER. METHODS: WE REVIEWED 136 PATIENTS WHO UNDERWENT EVAR FOR ATHEROSCLEROTIC AAA BETWEEN JULY 2008 AND JULY 2014 WITH ONE OF THREE STENT GRAFTS (EXCLUDER [W. L. GORE <(>&<)> ASSOCIATES, (B)(4)], POWERLINK [ENDOLOGIX INC, (B)(4)], AND ENDURANT [MEDTRONIC VASCULAR, (B)(4)]). STARTING FROM 2013, THE MEAN BLOOD PRESSURE OF 76 PARTICIPATING PATIENTS (TREATMENT GROUP) WAS MAINTAINED AT 75 TO 90MMHG FOR THE INITIAL 48 HOURS AFTER EVAR. THE INCIDENCE OF T2E AT 7 DAYS AND AAA SAC DIAMETER 12 MONTHS AFTER EVAR WERE EVALUATED USING COMPUTED TOMOGRAPHY SCANNING. THE RESULTS SO OBTAINED WERE THEN COMPARED WITH THOSE OF THE CONTROL GROUP COMPOSED OF 60 CONSECUTIVE PATIENTS WHO UNDERWENT EVAR BEFORE 2013. RESULTS: THE INCIDENCE OF T2E AT 7 DAYS WAS SIGNIFICANTLY LOWER IN PATIENTS WHO RECEIVED TREATMENT (TREATMENT GROUP, 19.7%; CONTROL GROUP, 40.0%; P ¼ .013), AND AAA SAC DIAMETER AT 12 MONTHS IN THE TREATMENT GROUP HAD A MEAN DECREASE OF 5.1 MM COMPARED WITH THE MEAN 2.2 MM IN THE CONTROL GROUP (P ¼ .004). IN MULTIVARIATE REGRESSION ANALYSIS, BPM WAS SIGNIFICANTLY RELATED TO THE REDUCTION OF INCIDENCE OF T2E AT 7 DAYS (ODDS RATIO, 0.31; P ¼ .007) AND A DECREASE IN AAA SAC DIAMETER AT 12 MONTHS (P ¼ .005). IN ADDITION, ALTHOUGH THEUSE OF ENDURANT HAD LESS EFFECT, THE USE OF EXCLUDER UNDER CONTROLLED BLOOD PRESSURE CONDITIONS IMPROVED THE INCIDENCE OF T2E FROM 80% TO 23% COMPARED WITH THOSE UNDER NORMAL POSTOPERATIVE MANAGEMENT (P ¼ .001). CONCLUSIONS: THE INITIAL 2-DAY POSTOPERATIVE BPM MIGHT HAVE POSITIVE EFFECTS, SUCH AS LOWER INCIDENCE OF T2E AND FACILITATION OF AAA SAC SHRINKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682494 TALENT AAA STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR