BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT

    MDR report key: 3778623 · Received April 29, 2014

    Report

    Report Number
    2953200-2014-00877
    Event Type
    Death
    Date Received
    April 29, 2014
    Date of Event
    December 17, 2013
    Report Date
    April 4, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXACT DATE OF DEATH IS UNKNOWN. (B)(4). EVALUATION, CONCLUSION: OFF-LABEL, UNAPPROVED, OR CONTRAINDICATED USE (PRE-OPERATIVE RUPTURE).

    Description of Event or Problem · 1

    METABOLIC SYNDROME IS ASSOCIATED WITH TYPE II ENDOLEAK AFTER ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR. HALL MR, PROTACK CD, AS SI R, WILLIAMS WT, WONG DJ, LU D, MUHS BE, DARDIK A. (J VASC SURG. 2014 APR;59(4):938-43). DOI: 10.1016/J.JVS.2013.10.081. EPUB 2013 DEC 17. THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: MYOCARDIAL ISCHEMIA, COLON ISCHEMIA, RENAL INSUFFICIENCY, ENDOLEAK, RESPIRATORY FAILURE; PROLONGED INTUBATION; AND DEATH. NO FURTHER INFORMATION IS AVAILABLE FOR THESE EVENTS. OBJECTIVE: TYPE II ENDOLEAK IS USUALLY A BENIGN FINDING AFTER ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR (EVAR). IN SOME PATIENTS, HOWEVER, TYPE II ENDOLEAK LEADS TO ANEURYSM SAC EXPANSION AND THE NEED FOR FURTHER INTERVENTION. WE EXAMINED WHICH FACTORS, IN PARTICULAR THE COMPONENTS OF METABOLIC SYNDROME (METS), WOULD LEAD TO AN INCREASE RISK OF ENDOLEAK AFTER EVAR. METHODS: THE MEDICAL RECORDS OF ALL PATIENTS WHO UNDERWENT EVAR BETWEEN 2002 AND 2011 AT THE VETERANS AFFAIRS CONNECTICUT HEALTHCARE SYSTEM WERE REVIEWED. METS WAS DEFINED AS THE PRESENCE OF THREE OR MORE OF THE FOLLOWING: HYPERTENSION (BLOOD PRESSURE =130 MM HG/=90 MM HG), SERUM TRIGLYCERIDES =150 MG/DL, SERUM HIGH-DENSITY LIPOPROTEINS =50 MG/DL FOR WOMEN AND =40 MG/DL FOR MEN, BODY MASS INDEX =30 KG/M(2), AND FASTING BLOOD GLUCOSE =110 MG/DL. DEVELOPMENT OF ENDOLEAK, INCLUDING SPECIFIC ENDOLEAK TYPE, WAS DETERMINED BY REVIEW OF STANDARD RADIOLOGIC SURVEILLANCE. RESULTS: DURING A 9-YEAR PERIOD, 79 MALE PATIENTS (MEAN AGE, 73.5 YEARS), UNDERWENT EVAR FOR INFRARENAL ABDOMINAL AORTIC ANEURYSM (MEAN 6.2 CM MAXIMAL TRANSVERSE DIAMETER). METS WAS PRESENT IN 52 PATIENTS (66%). THE DISTRIBUTION OF METS FACTORS AMONG ALL PATIENTS WAS HYPERTENSION IN 86%, HYPERTRIGLYCERIDEMIA IN 72%, DECREASED HIGH-DENSITY LIPOPROTEIN IN 68%, DIABETES IN 37%, AND A BODY MASS INDEX OF =30 KG/M(2) IN 30%. NO SURVIVAL DIFFERENCE WAS FOUND BETWEEN THE METS AND NON-METS GROUPS (P = .66). THERE WAS NO DIFFERENCE IN PERIOPERATIVE MYOCARDIAL INFARCTION OR VISCERAL ISCHEMIA IMMEDIATELY POSTOPERATIVELY BETWEEN THETWO GROUPS. PATIENTS WITH METS HAD A SIGNIFICANT INCREASE IN ACUTE KIDNEY INJURY (N = 7, P = .0128). ENDOLEAKS OF ALL TYPES WERE DETECTED IN 26% (N = 20) OF ALL PATIENTS; PATIENTS WITH METS HAD MORE ENDOLEAKS THAN PATIENTS WITHOUT METS (35% VS 7.4%, P = .0039). OF THE 19 TYPE II ENDOLEAKS, 79% WERE PRESENT AT THE TIME OF EVAR AND ONLY 21% DEVELOPED DURING SURVEILLANCE; 95% HAD METS (P = .0007). CONCLUSIONS: TYPE II ENDOLEAK AFTER EVAR FOR ABDOMINAL AORTIC ANEURYSM IS ASSOCIATED WITH METS. WHETHER THESE PATIENTS ARE SUBJECT TO MORE SUBSEQUENT INTERVENTION DUE TO SAC EXPANSION IS UNCLEAR. METS MAY BE A FACTOR TO CONSIDER IN THE TREATMENT OF TYPE II ENDOLEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257281 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Death| R