BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALIANT STENT GRAFT

    MDR report key: 13175654 · Received January 6, 2022

    Report

    Report Number
    9612164-2022-00081
    Event Type
    Injury
    Date Received
    January 6, 2022
    Date of Event
    July 7, 2021
    Report Date
    January 6, 2022
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; INTRAOPERATIVE STENT-GRAFT-INDUCED AORTIC INTIMAL INTUSSUSCEPTION DURING TEVAR FOR TYPE B AORTIC DISSECTION MA ET AL, JOURNAL OF ENDOVASCULAR THERAPY 2021, VOL. 28(6) 860¿870. DOI: 10.1177/15266028211028213. EXACT DATE OF IMPLANT UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    VALIANT STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF TYPE B AORTIC DISSECTIONS (TBAD) ON UNKNOWN DATES. THE FOLLOWING ADVERSE EVENTS WERE REPORTED: INTRAOPERATIVE STENT-GRAFT (SG)-INDUCED AORTIC INTIMAL INTUSSUSCEPTION (ISAII)/DISSECTION AND INTESTINAL ISCHEMIA. THE CAUSE OF THE ADVERSE EVENTS ARE UNDETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739572 VALIANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND UNK-CV-SR-VALIANT

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Required Intervention