BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II ILIAC STENT GRAFT

    MDR report key: 10578702 · Received September 24, 2020

    Report

    Report Number
    9612164-2020-03579
    Event Type
    Injury
    Date Received
    September 24, 2020
    Date of Event
    February 18, 2020
    Report Date
    September 24, 2020
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED; CLINICAL ASPECTS AND PRESENT CHALLENGES OF THE SEAT BELT AORTA GOUVEIA E MELO R, AMORIM P, RAMOS SOARES T, FERNANDES E FERNANDES R, MINISTRO A, GARRIDO P, FERNANDES E FERNANDES J, <(>&<)> MENDES PEDRO L. JOURNAL OF VASCULAR SURGERY 2020;72 (3) PP. 995-1004. HTTPS://DOI.ORG/10.1016/J.JVS.2019.11.038. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A (B)(6) YEAR OLD MALE SUFFERED A BLUNT TRAUMATIC AORTIC DISSECTION LOCATED BELOW THE RENAL ARTERIES TO THE AORTIC BIFURCATION OF THE AORTA. THE DISSECTION CONTAINED A LARGE INTIMAL FLAP WITH NO AORTIC CONTOUR ABNORMALITY. AN ENDURANT II 16 X 82MM ILIAC LIMB WAS IMPLANTED AS TREATMENT WITH NO REPORTED ISSUE. AT 12 MONTH FOLLOW-UP, THE PATIENT HAD DEVELOPED RE-STENOSIS AT THE DISTAL END OF THE STENT. HOWEVER, THE PATIENT WAS ASYMPTOMATIC AND REFUSED FURTHER INTERVENTION; THEREFORE, CONSERVATIVE MANAGEMENT WAS ADOPTED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1045845 ENDURANT II ILIAC STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND ETLW1610C82EE

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other