BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT-II

    MDR report key: 6095816 · Received November 11, 2016

    Report

    Report Number
    2953200-2016-01939
    Event Type
    Injury
    Date Received
    November 11, 2016
    Date of Event
    March 11, 2016
    Report Date
    October 19, 2016
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: SEX. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE "PRECLOSE PERCUTANEOUS ENDURANT ENDOGRAFTING WITH THE PROGLIDE DEVICE: A SAFE AND FEASIBLE COMBINATION" M. VAN DORP, M. RUYSSERS, Z. AMAJOUD, P. LAUWERS, P. E. VAN SCHIL <(>&<)> J. M. H. HENDRIKS (ACTA CHIRURGICA BELGICA) DOI: 10.1080/0 0015458.2015.11681100. ENDURANT AND ENDURANT II STENT GRAFT SYSTEMS WERE IMPLANTED IN PATIENTS FOR THE ENDOVASCULAR TREATMENT OF ABDOMINAL ANEURYSM REPAIR BETWEEN APRIL 2011 AND APRIL 2014. THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: ACUTE MYOCARDIAL INFARCTION, SURGICAL VASCULARIZATION, HOSPITALIZATION, TRANSIENT RENAL FAILURE. ABSTRACT BACKGROUND : ENDOVASCULAR REPAIR OF ABDOMINAL AORTIC ANEURYSMS HAS BEEN REVOLUTIONIZED OVER THE LAST TWO DECADES. OPENING THE DOORS FOR A PERCUTANEOUS APPROACH BY AVOIDING SURGICAL EXPOSURE OF THE VASCULAR ACCESS SITE. THE GOAL OF THIS REPORT IS TO ANALYZE THE FEASIBILITY AND EFFICACY OF USING PERCLOSE PROGLIDE" THROUGH A PRECLOSE TECHNIQUE IN A PERCUTANEOUS APPROACH TO ENDURANT" ENDOGRAFTING FOR ASYMPTOMATISCH INFRARENAL AORTIC ANEURYSMS IN AN ELECTIVE SETTING. METHODS : BETWEEN APRIL 2011 AND APRIL 2014, 45 CONSECUTIVE PATIENTS UNDERWENT PERCUTANEOUS ENDOVASCULAR AORTIC ANEURYSM REPAIR (PEVAR) FOR AN ASYMPTOMATIC INFRARENAL AORTIC ANEURYSM. CLOSURE OF PERCUTANEOUS ACCESS SITES WAS ENSURED WITH PERCLOSE PROGLIDE IN A PRECLOSE TECHNIQUE. DATA WERE COLLECTED IN A PROSPECTIVE MAINTAINED DATABASE WITH A FOLLOW-UP PERIOD OF ONE MONTH. PATIENT DEMOGRAPHICS, ANEURYSMAL CHARACTERISTICS, PROCEDURAL DETAILS AND COMPLICATIONS WERE RECORDED. RESULTS: A TOTAL OF 170 PROGLIDE DEVICES WERE USED TO CLOSE 85 ACCESS SITES. ADEQUATE HEMOSTASIS WAS OBTAINED IN 96.5 PERCENT (82 OF 85 ACCESS SITES). CONVERSION TO A FEMORAL CUTDOWN WAS NECESSARY IN 2.4% (2 OF 85 ACCESS SITES). THE MEAN HOSPITALIZATION WAS 2.6 DAYS AND 86.7 PERCENT OF PATIENTS WERE DISCHARGED WITHIN 2 DAYS. THE INCIDENCE OF POSTPROCEDURAL ACCESS-RELATED COMPLICATIONS WAS 2.2%. CONCLUSIONS : PEVAR USING THE PERCLOSE PROGLIDE IN PRECLOSING 14FR TO 20FR ACCESS SITES FOR ENDURANT ENDOGRAFTING IN THE TREATMENT OF ASYMPTOMATIC INFRARENAL AORTIC ANEURYSMS IS FEASIBLE AND EFFECTIVE. MOREOVER, THE PERCUTANEOUS APPROACH ALLOWS FOR PROCEDURES TO BE PERFORMED UNDER LOCAL ANESTHESIA, WHILE PROVIDING A LOW RISK FOR ACCESS-RELATED COMPLICATIONS AND A RELATIVELY SHORT HOSPITALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746278 ENDURANT-II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R