BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANEURX ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2973073 · Received February 21, 2013

    Report

    Report Number
    2953200-2013-00311
    Event Type
    Death
    Date Received
    February 21, 2013
    Report Date
    January 28, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (DEATH, ENDOLEAK, INFECTION, STENT GRAFT OCCLUSION, ANEURYSM RUPTURE, STENT GRAFT MIGRATION); PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (TYPE II ENDOLEAK, PRE-OPERATIVELY RUPTURED ANEURYSM); UNAPPROVED USE OF DEVICE (TREATMENT OF PATIENTS WITH PRE-OPERATIVELY RUPTURED ANEURYSMS). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (TYPE II ENDOLEAK, PRE-OPERATIVELY RUPTURED ANEURYSM);OPERATIONAL CONTEXT CONTRIBUTED TO EVENT (TREATMENT OF PATIENTS WITH PRE-OPERATIVELY RUPTURED ANEURYSMS).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; ENDOVASCULAR REPAIR OF RUPTURED INFRARENAL ABDOMINAL AORTIC ANEURYSM IS ASSOCIATED WITH LOWER 30-DAY MORTALITY AND BETTER 5-YEAR SURVIVAL RATES THAN OPEN SURGICAL REPAIR; JOURNAL OF VASCULAR SURGERY; 2013; 57, 368-75. OBJECTIVE: ENDOVASCULAR ANEURYSM REPAIR (EVAR) DECREASES 30-DAY MORTALITY FOR PATIENTS WITH RUPTURED ABDOMINAL AORTIC ANEURYSMS (R-AAAS) COMPARED WITH OPEN SURGICAL REPAIR (OSR). HOWEVER, WHICH PATIENTS BENEFIT OR WHETHER THERE IS ANY LONG-TERM SURVIVAL ADVANTAGE IS UNCERTAIN. METHODS: FROM 2002 TO 2011, 283 PATIENTS WITH R-AAA UNDERWENT EVAR (N = 120 [42.4%]) OR OSR (N = 163 [57.6%]) AT ALBANY MEDICAL CENTER. ALL DATA WERE COLLECTED PROSPECTIVELY. PATIENTS WERE ANALYZED ON AN INTENTION-TO-TREAT BASIS, AND OUTCOMES WERE EVALUATED BY A LOGISTIC REGRESSION MULTIVARIABLE MODEL. KAPLAN-MEIER ANALYSIS WAS USED TO COMPARE LONG-TERM SURVIVAL. RESULTS: THE EVAR PATIENTS HAD A SIGNIFICANTLY LOWER 30-DAY MORTALITY THAN DID THE OSR PATIENTS (29/120 [24.2%] VS 72/163 [44.2%]; P <(><<)> .005) AND BETTER CUMULATIVE 5-YEAR SURVIVAL (37%VS 26%; P <(><<)> .005). MEN BENEFITED MORE FROM EVAR (MORTALITY: 20.9% FOR EVAR VS 44.3% FOR OSR; P <(><<)> .001) THAN DID WOMEN (MORTALITY: 32.4% VS 43.9%; P = .39). AGE 80 YEARS WAS A SIGNIFICANT PREDICTOR OF DEATH FOR EVAR (ODDS RATIO [OR], 1.07; P [ .003) BUT NOT FOR OSR (OR, 1.04; P[.056). PREEXISTING HYPERTENSION WAS A SIGNIFICANT PREDICTOR OF SURVIVAL FOR BOTH EVAR (OR, 0.17; P <(><<)> .001) AND OSR (OR, 0.48; P [ .021). ALMOST ONE FOURTH OF EVAR PATIENTS (21/91 [23.1%]) REQUIRED SECONDARY INTERVENTIONS. SURVIVAL ADVANTAGE WAS MAINTAINED FOR EVAR PATIENTS TO 5 YEARS. CONCLUSIONS: FOR R-AAA, EVAR REDUCES THE 30-DAY MORTALITY AND IMPROVES LONG-TERM SURVIVAL UP TO 5 YEARS. HOWEVER, WHEREAS OPEN SURVIVORS REQUIRE FEW GRAFT-RELATED INTERVENTIONS, UP TO 23% OF EVAR PATIENTS WILL REQUIRE RE-INTERVENTION FOR ENDOLEAKS OR GRAFT MIGRATION. CLOSE FOLLOW-UP OF ALL EVAR SURVIVORS IS MANDATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76520 ANEURX ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1