BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 4771878 · Received May 14, 2015

    Report

    Report Number
    9612164-2015-00689
    Event Type
    Injury
    Date Received
    May 14, 2015
    Date of Event
    February 3, 2015
    Report Date
    May 22, 2015
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; OUTCOME OF ELECTIVE TREATMENT OF ABDOMINAL AORTIC ANEURYSM IN ELDERLY PATIENTS KEVIN DE LEUR, HANS C. FLU, GWAN H. HO, HANS G.W. DE GROOT, EELCO J. VEEN, LIJCKLE VAN DER LAAN (INTERNATIONAL JOURNAL OF SURGERY 20 15;15:117-123) AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF ABDOMINAL ANEURYSM REPAIR. DURING THE RETROSPECTIVE STUDY THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: TYPE I ENDOLEAK, RE-INTERVENTION, EMBOLECTOMY, BLEEDING, OPEN REPAIR, DEATH. INTRODUCTION: OPTIMAL MANAGEMENT OF AN ABDOMINAL AORTIC ANEURYSM (AAA) IN THE ELDERLY IS NOT STRAIGHTFORWARD. WE EVALUATED TREATMENT RESULTS OF ELDERLY PATIENTS WITH ASYMPTOMATIC ABDOMINAL AORTIC ANEURYSM THAT MET THE TREATMENT CRITERIA IN OUR CLINIC. METHODS: HOSPITAL CHARTS BETWEEN JANUARY 2005 AND DECEMBER 2012 WERE REVIEWED OF ALL PATIENTS 70 YEARS AND OLDER DIAGNOSED WITH AAA WITH A DIAMETER THAT MET THE TREATMENT CRITERIA. PATIENTS WERE STRATIFIED BY AGE (GROUP I: 70-79 YEARS, GROUP II: 80 YEARS OR OLDER) AND TREATMENT. OUTCOME WAS MEASURED IN TERMS OF SURVIVAL AND COMPLICATIONS. RESULTS: IN TOTAL 283 PATIENTS (240 (85%) MEN, MEDIAN AGE 77.4 YEARS) WERE INCLUDED, 211 (75%) IN GROUP I AND 72 (25%) IN GROUP II. THERE WAS AN OVERALL SIGNIFICANTLY HIGHER MORTALITY RATE IN THE OCTOGENARIANS (P <(><<)> 0.01). THIS DIFFERENCE WAS NOT SEEN IN THE GROUPS TREATED CONSERVATIVELY AND WITH OPEN REPAIR. HOWEVER, IN THE EVAR GROUP THERE WAS A SIGNIFICANTLY HIGHER MORTALITY RATE IN OCTOGENARIANS (P <(><<)> 0.01). CONCLUSION: LONG-TERM OUTCOME AFTER EVAR PROCEDURES RESULTS IN HIGHER MORTALITY RATES FOR THE POPULATION OLDER THAN 80 YEARS AS COMPARED TO THE GROUP AGED 70-79 YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314745 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND UNK-CV-SR-ENDURANT

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Required Intervention