BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANEURX - UNK

    MDR report key: 8225763 · Received January 8, 2019

    Report

    Report Number
    2953200-2019-00042
    Event Type
    Malfunction
    Date Received
    January 8, 2019
    Date of Event
    October 23, 2017
    Report Date
    January 8, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM THE JOURNAL ARTICLE ENTITLED; CHARACTERIZATION AND OUTCOMES OF REINTERVENTIONS IN FOOD AND DRUG ADMINISTRATION-APPROVED VERSUS TRIAL ENDOVASCULAR ANEURYSM REPAIR DEVICES. ALEXANDER S. FAIRMAN, MD, GRACE J. WANG, MD, BENJAMIN M. JACKSON, MD, PAUL J. FOLEY, MD, SCOTT M. DAMRAUER, MD, VENKAT KALAPATAPU, MD, MICHAEL A. GOLDEN, MD, AND RONALD M. FAIRMAN, MD J VASC SURG 2018 (67) ISSUE 4 HTTPS://DOI.ORG/10.1016/J.JVS.2017.08.058. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ANUERX STENT GRAFTS WERE IMPLANTED INTO PATIENTS FOR ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR. THE AVERAGE ANEURYSM SIZE WAS 59MM. THE FOLLOWING EVENTS WERE REPORTED: MALFUNCTION: TYPE I ENDOLEAK TYPE III ENDOLEAK LIMB KINK ENDOTENSION SERIOUS INJURY. ABSTRACT OBJECTIVE: PUBLISHED RATES OF REINTERVENTION AFTER ENDOVASCULAR ANEURYSM REPAIR (EVAR) RANGE FROM 10% TO 30%. WE EVALUATED A SINGLE UNIVERSITY CENTRE¿S EXPERIENCE WITH REINTERVENTIONS IN THE CONTEXT OF FOOD AND DRUG ADMINISTRATION (FDA)-APPROVED AND TRIAL DEVICES. METHODS: RETROSPECTIVE DATA COLLECTION WAS PERFORMED FOR PATIENTS WHO UNDERWENT INFRARENAL EVAR AND REQUIRED REINTERVENTION FROM 2000 TO 2016. TRIAL DEVICES INCLUDED THOSE USED IN FDA FEASIBILITY AND PIVOTAL TRIALS. TIME-TO-EVENT ANALYSIS WAS PERFORMED USING COX REGRESSION. PREDICTORS OF MORTALITY AND EXPLANATION WERE EVALUATED USING LOGISTIC REGRESSION; SURVIVAL ANALYSIS WAS PERFORMED USING KAPLAN-MEIER METHODS. RESULTS: FROM 2000 TO 2016, THERE WERE 1835 EVARS PERFORMED, AND 137 PATIENTS (116 MEN; MEAN AGE, 72.2 6 10.0 YEARS) UNDERWENT REINTERVENTION WITH A MEAN ANEURYSM SIZE OF 5.9 6 1.2 CM. THE MEDIAN FOLLOW-UP WAS 5 YEARS WITH AN OVERALL SURVIVAL OF 70.1%. THE OVERALL REINTERVENTION RATE WAS 7.5%. FDA-APPROVED DEVICES HAD A REINTERVENTION RATE OF 6.4%, WHEREAS TRIAL DEVICES HAD A RATE OF 14.4% (P <(><<)> .001). FOR ALL DEVICES, THE MOST COMMON CAUSE OF REINTERVENTION WAS TYPE II ENDOLEAK (52.5%), FOLLOWED BY TYPE I ENDOLEAK (18.2%), TYPE III ENDOLEAK (9.5%), LIMB KINK (7.3%), ILIAC OCCLUSIVE DISEASE (5.8%), ENDOTENSION (1.5%), AND OTHER. THE OVERALL MEAN TIME TO FIRST REINTERVENTION WAS 2.3 6 2.5 YEARS, AND UNIVARIATE COX REGRESSION IDENTIFIED MALE GENDER (HAZARD RATIO, 1.91; 95% CONFIDENCE INTERVAL [CI], 1.17-3.10; P ¼ .010) AND AGE AT THE TIME OF EVAR (HAZARD RATIO, 1.03; 95% CI, 1.01-1.05; P ¼ .006) AS RISK FACTORS FOR TIME TO FRST REINTERVENTION. AMONG PATIENTS REQUIRING REINTERVENTION, THE MEAN NUMBER OF REINTERVENTIONS FOR TRIAL DEVICES WAS SIGNIFICANTLY GREATER THAN THAT FOR FDA-APPROVED DEVICES (2.18 VS 1.65; P ¼ .01). TRIAL DEVICES REQUIRING REINTERVENTION HAD A NEARLY THREEFOLD HIGHER ODDS FOR THE NEED FOR MORE THAN TWO REINTERVENTIONS (ODDS RATIO, 2.88; 95% CI, 1.12-7.37; P ¼ .034). TRIAL DEVICE, CAUSE OF REINTERVENTION, AND TYPE OF REINTERVENTION WERE NOT PREDICTIVE OF THE NEED FOR EXPLANTATION OR MORTALITY, BUT THE NUMBER OF REINTERVENTIONS WAS SIGNIFICANTLY ASSOCIATED WITH THE NEED FOR EXPLANTATION (ODDS RATIO, 1.86; 95% CI, 1.17-2.96; P ¼ .012). EVAR DEVICE AND THE NEED FOR EXPLANTATION DID NOT HAVE AN IMPACT ON MORTALITY. CONCLUSIONS: DESPITE THE RIGOROUS NATURE OF PATIENT ENROLMENT IN CLINICAL TRIALS AND THE DEVELOPMENT OF NEWER ITERATIONS OF INVESTIGATIONAL DEVICES, PATIENTS UNDERGOING EVAR WITH TRIAL DEVICES ARE MORE LIKELY TO UNDERGO A GREATER NUMBER OF REINTERVENTIONS THAN WITH FDA-APPROVED DEVICES. ALTHOUGH MORTALITY AND THE NEED FOR EXPLANTATION WERE NOT SIGNIFICANTLY ASSOCIATED WITH TRIAL DEVICES, THE FINDING OF A GREATER NUMBER OF REINTERVENTIONS HIGHLIGHTS THE NEED TO PROPERLY INFORM PATIENTS WILLING TO PARTAKE IN INVESTIGATIONAL DEVICE TRIALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21015 ANEURX - UNK SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND UNK-CV-SR-ANEURX

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR