BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT STENT GRAFT

    MDR report key: 9231637 · Received October 24, 2019

    Report

    Report Number
    9612164-2019-04488
    Event Type
    Injury
    Date Received
    October 24, 2019
    Date of Event
    August 23, 2018
    Report Date
    October 24, 2019
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM THE JOURNAL ARTICLE ENTITLED; OUTCOMES OF SURGICAL EXPLANTATION OF INFECTED AORTIC GRAFTS AFTER ENDOVASCULAR AND OPEN ABDOMINAL ANEURYSM REPAIR. JOHANNES F. SCHAEFERS, GIUSEPPE PANUCCIO, BERND KASPRZAK, BENJAMIN HEINE, GIOVANNI B. TORSELLO, NANI OSAD AND MARCO V. USAI JOURNAL OF ENDOVASCULAR THERAPY 2019 57(1) HTTPS://DOI.ORG/10.1016/J.EJVS.2018.07.021. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ENDURANT STENT GRAFTS WERE IMPLANTED IN PATIENT FOR ENDOVASCULAR ANEURYSM REPAIR AND WERE EXPLANTED DUE TO STENT GRAFT INFECTION. THE FOLLOWING EVENTS WERE REPORTED- SERIOUS INJURY: RUPTURE INFECTION ACUTE KIDNEY INJURY MULTI-ORGAN FAILURE MAJOR ADVERSE CARDIAC AND CEREBROVASCULAR EVENTS WOUND INFECTION PARALYSIS SEPSIS HAEMORRHAGIC SHOCK AORTO-DUODENAL FISTULA RUPTURE ANEMIA REQUIRING TRANSFUSION BOWEL ISCHEMIA BLOOD LOSS DEATH-PATIENT DEATHS WERE ALSO REPORTED, HOWEVER THERE IS NO CAUSAL LINK THAT A MEDTRONIC DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE DEATHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1025468 ENDURANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention