BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ILIAC STENT GRAFT

    MDR report key: 12292456 · Received August 9, 2021

    Report

    Report Number
    9612164-2021-03040
    Event Type
    Injury
    Date Received
    August 9, 2021
    Date of Event
    December 26, 2020
    Report Date
    August 9, 2021
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED; ENDOVASCULAR REPAIR OF SPONTANEOUS ILIAC VEIN RUPTURE ZHENG H, YANG W-Z, KE K, HUANG J-Y. ANNALS OF VASCULAR SURGERY 2021; 73: 510.E1¿510.E4 HTTPS://DOI.ORG/10.1016/J.AVSG.2020.11.040. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A PATIENT PRESENTED TO ED WITH ABDOMINAL AND BACK PAIN. AN ABDOMINOPELVIC CT SHOWED A LARGE HEMATOMA IN THE LOWER ABDOMINAL CAVITY AND AROUND THE LIVER. CONTRAST EXTRAVASATION AND VENOUS THROMBUS OF THE LEFT EXTERNAL ILIAC VEIN WERE DISCOVERED. THE PATIENT WAS BROUGHT TO THE INTERVENTIONAL SUITE. A VENOGRAM SHOWED THE LEFT FEMORAL VEIN WAS FULL OF THROMBUS AND FORMATION OF COLLATERAL CIRCULATION. THEN, A VENOGRAM SHOWED RUPTURES ON THE LEFT EXTERNAL ILIAC VEIN AND STENOSIS OF THE LEFT COMMON ILIAC VEIN, SUGGESTIVE OF MAYETHURNER SYNDROME. AN ENDURANT STENT GRAFT LIMB WAS PLACED TO COVER THE RUPTURES. STENOSIS WAS OBSERVED THEN BUT THIS RESOLVED USING A NON MDT BALLOON EXPANSION CATHETER ON THE AREA. AN ABDOMINOPELVIC CT PERFORMED AT HALF MONTH SHOWED THE ABDOMINAL HEMATOMA DISAPPEARED. THE VENA CAVA FILTER WAS REMOVED. THE PATIENT RECOVERED WELL AND WAS DISCHARGED AFTER 2 DAYS. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1190345 ENDURANT ILIAC STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND ENLW1613C95EE

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention