BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT STENT GRAFT

    MDR report key: 9165250 · Received October 8, 2019

    Report

    Report Number
    9612164-2019-04265
    Event Type
    Injury
    Date Received
    October 8, 2019
    Date of Event
    April 1, 2011
    Report Date
    October 8, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM THE JOURNAL ARTICLE ENTITLED: FENESTRATION OF AN IATROGENIC AORTIC DISSECTION AFTER ENDOVASCULAR ANEURYSM REPAIR. JIP L. TOLENAAR, JASPER W. VAN KEULEN, EVERT-JAN VONKEN, JOOST A. VAN HERWAARDEN, FRANS L. MOLL, AND GERT J. DE BORST JOURNAL OF ENDOVASCULAR THERAPY 2011 18 (2) HTTPS://DOI.ORG/10.1583/10-3330.1. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    AN ENDURANT BIFURCATED STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR AORTIC REPAIR OF A PSEUDOANEURYSM. THE PATIENT PREVIOUSLY HAD AN OPEN REPAIR OF AN ABDOMINAL AORTIC ANEURYSM WITH AN AORTOBI-ILIAC PROSTHESIS AND A PSEUDOANEURYSM WAS DIAGNOSED AT THE PROXIMAL ANASTOMOSIS TWO YEARS POST THE PROCEDURE. CT TWO DAYS POST THE EVAR PROCEDURE SHOWED A TYPE B DISSECTION EXTENDING DISTALLY FROM THE ORIGIN OF THE LEFT SUBCLAVIAN ARTERY DOWN TO THE LEFT RENAL ARTERY. THE PATIENT WAS ASYMPTOMATIC AND WAS TREATED CONSERVATIVELY INITIALLY. HOWEVER, LATER THAT NIGHT THE PATIENT DEVELOPED PAIN, ACCOMPANIED BY BLOOD PRESSURE DROP AND MALAISE. ANGIOGRAM SHOWED THAT THE DISSECTION FLAP HAD CREATED A DYNAMIC STENOSIS. IT WAS DECIDED TO TREAT THE PATIENT WITH A BALLOON FENESTRATION OF THE INTIMA AND THE EVENT WAS REPORTED TO HAVE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    962707 ENDURANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention