BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 3892590 · Received June 24, 2014

    Report

    Report Number
    2953200-2014-01266
    Event Type
    Injury
    Date Received
    June 24, 2014
    Date of Event
    November 29, 2012
    Report Date
    May 30, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    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;OUTCOMES OF ENDOVASCULAR ANEURYSM REPAIR WITH 2 DIFFERENT ENDOGRAFT SYSTEMS WITH SUPRARENAL FIXATION IN PATIENTS WITH HOSTILE INFRARENAL AORTIC ANATOMY. GEORGE A. ANTONIOU, MD, PHD, GEORGE S. GEORGIADIS, MD, LAURENCE GLANCZ, MRCS, BSC, MICHAEL DELBRIDGE, MD, FRCS, DAVID MURRAY, MD, FRCS1, J. VINCENT SMYTH, CHM, FRCS, MILTOS K. LAZARIDES, MD, EBSQVASC, AND FERDINAND SERRACINO-INGLOTT, MD, MSC, FRCS. VASCULAR AND ENDOVASCULAR SURGERY 47(1) 9-18 AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN PATIENTS FOR THE ENDOVASCULAR TREATMENT OF ABDOMINAL AORTIC ANEURYSM. DURING THE RETROSPECTIVE STUDY, THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: DEATH, PROXIMAL TYPE I ENDOLEAK, TYPE II ENDOLEAK, RETROPERITONEAL HEMATOMA, WOUND INFECTION, LYMPHOCELE, PNEUMONIA, PAROXYSMAL ATRIAL FIBRILLATION, CEREBROVASCULAR EVENT, RENAL IMPAIRMENT, FATAL MYOCARDIAL INFARCTION. ABSTRACT OBJECTIVE: TO EVALUATE 2 DIFFERENT AORTIC ENDOGRAFT SYSTEMS WITH SUPRARENAL FIXATION IN PATIENTS WITH UNFAVORABLE NECK MORPHOLOGY. METHODS: A PROSPECTIVE OBSERVATIONAL STUDY ASSIGNING PATIENTS WITH ABDOMINAL AORTIC ANEURYSM WITH UNFRIENDLY NECK ANATOMY TREATED WITH 2 DIFFERENT ENDOGRAFT SYSTEMS (ENDURANT AND ZENITH) WAS CONDUCTED. THE LOG-RANK TEST WAS APPLIED TO INVESTIGATE THE DIFFERENCES IN CUMULATIVE OUTCOME PARAMETERS. RESULTS: SUCCESSFUL ENDOGRAFT IMPLANTATION WAS ACHIEVED IN ALL PATIENTS. REQUIREMENT FOR TROUBLESHOOTING TECHNIQUES WAS SIMILAR IN THE 2 GROUPS (P ¼ .156 AND P ¼ .081, RESPECTIVELY). IN-HOSPITAL PROCEDURE-RELATED MORBIDITY OCCURRED IN 7 PATIENTS (ZENITH VS ENDURANT, P ¼ .690). FREEDOM FROM ANY TYPE OF ENDOLEAK AND OVERALL MORTALITY DID NOT DIFFER SIGNIFICANTLY BETWEEN THE GROUPS (LOG-RANK TEST, P ¼ .068 AND P ¼ .087). REINTERVENTIONS WERE MORE COMMONLY REQUIRED IN THE ZENITH GROUP (LOG-RANK REST, P ¼ .041), AND WERE ALL NONGRAFT/ANEURYSM-RELATED. CONCLUSIONS: SIMILAR PERFORMANCES OF THE ZENITH AND THE ENDURANT ENDOGRAFT SYSTEMS WERE DEMONSTRATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368454 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Required Intervention