BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT BIFURCATED STENT GRAFT

    MDR report key: 5029367 · Received August 25, 2015

    Report

    Report Number
    2953200-2015-01433
    Event Type
    Injury
    Date Received
    August 25, 2015
    Date of Event
    July 16, 2015
    Report Date
    August 4, 2015
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EXACT DATES OF THE EVENTS ARE UNKNOWN. THE EXACT DATE OF IMPLANT IS UNKNOWN.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; PLATELET ACTIVATION AFTER ENDOVASCULAR REPAIR OF ABDOMINAL AORTIC ANEURYSM. ELENI ARNAOUTOGLOU, GEORGE KOUVELOS, NEKTARIO PAPA, ACHILLEAS KARAMOUTSIOS, VASILIOS BOURIS, GEORGE VARTHOLOMATOS AND MILTIADIS MATS AGKAS (VASCULAR DOI: 10.1177/1708538115596911). AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF ABDOMINAL ANEURYSM REPAIR. ADDITIONAL INFORMATION WAS RECEIVED FROM THE AUTHOR THAT THE FOLLOWING ADVERSE EVENTS WERE REPORTED: MI, STROKE, ACUTE RENAL FAILURE. ABSTRACT AIM: TO INVESTIGATE THE EFFECT OF ENDOVASCULAR ANEURYSM REPAIR (EVAR) ON PLATELET (PLT) FUNCTION AND REVEAL POSSIBLE ASSOCIATED FACTORS. METHODS: FIFTY CONSECUTIVE PATIENTS WERE INCLUDED. PLT COUNT AND ACTIVATION (CD62P-CD36), WHITE BLOOD CELL (WBC) COUNT, AND HIGH SENSITIVITY C-REACTIVE PROTEIN (HS-CRP) WERE MEASURED PREOPERATIVELY, AT THE FIRST AND THIRD POSTOPERATIVE DAY. RESULTS: EVAR ELICITED A SIGNIFICANT REDUCTION IN PLT COUNT FROM BASELINE TO FIRST DAY AFTER EVAR (P<(><<)>0.001), WHILE NO SIGNIFICANT DIFFERENCE WAS NOTED BETWEEN THE FIRST AND THIRD DAY. FURTHERMORE, CD62P EXPRESSION WAS MARKEDLY ELEVATED AT THE FIRST DAY AFTER EVAR (MEDIAN % POSITIVE PLTS FROM 13.7 AT BASELINE TO 22.1, P1/40.05), BUT RETURNED TO BASELINE LEVELS BY THE THIRD DAY. MAXIMUM ABDOMINAL AORTIC ANEURYSM DIAMETER WAS THE ONLY FACTOR THAT SIGNIFICANTLY AFFECTED THE CD62P VALUES (P1/40.005). POSTOPERATIVE CD36 VALUES WERE SIGNIFICANTLY CORRELATED WITH TOTAL ANEURYSM VOLUME (P1/40.05) AND WERE HIGHER IN ENDOGRAFTS MADE FROM POLYESTER (P1/40.01). THERE WERE NO CORRELATION BETWEEN PLT ACTIVATION AND HS-CRP, WBC, MAXIMUM TEMPERATURE, AND 30-DAY MORBIDITY. CONCLUSION: EVAR HAS ELUCIDATED A SIGNIFICANT REDUCTION IN PLT COUNT AND INCREASE IN PLT ACTIVATION AT THE IMMEDIATE POSTOPERATIVE PERIOD. THE TYPE OF THE ENDOGRAFT MATERIAL AND THE ANEURYSM MAXIMUM DIAMETER AND VOLUME APPEAR TO PLAY AN IMPORTANT ROLE IN PLT ACTIVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560750 ENDURANT BIFURCATED STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND ENBF3616C170EE

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Life Threatening