BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT - UNK

    MDR report key: 13341465 · Received January 25, 2022

    Report

    Report Number
    9612164-2022-00320
    Event Type
    Injury
    Date Received
    January 25, 2022
    Date of Event
    August 28, 2021
    Report Date
    January 25, 2022
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED; EXTENSIVE AORTIC STENT GRAFT COVERAGE FOR THORACOABDOMINAL AORTIC ANEURYSM IS ASSOCIATED WITH HEMORRHAGIC COMPLICATIONS INDUCED BY DISSEMINATED INTRAVASCULAR COAGULATION KAWASHIMA ET AL, ANN VASC SURG 2022; 78: 152¿160 HTTPS://DOI.ORG/10.1016/J.AVSG.2021.06.017. EXACT DATE OF IMPLANT UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    TALENT STENT GRAFTS WERE IMPLANTED IN PATIENTS DURING THE ENDOVASCULAR TREATMENT OF THORACOABDOMINAL ANEURYSM REPAIR ON UNKNOWN DATES. THE FOLLOWING ADVERSE EVENTS WERE REPORTED: THROMBOCYTOPENIA, DISSEMINATED INTRAVASCULAR COAGULATION (DIC), BLEEDING (GASTROINTESTINAL HEMORRHAGE, PETECHIAL HEMORRHAGE) HEMATOMA(RETROPERITONEAL HEMATOMA, & MESENTERIC HEMATOMA), HEMORRHAGIC CYSTITIS, ANASTOMOTIC PSEUDOANEURYSM, EPISTAXIS, INTERVENTION. THE CAUSE OF THE ADVERSE EVENTS ARE UNDETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687086 TALENT - UNK SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND CV-SR-UNK-TALENT

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention