BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK-CV-SR

    MDR report key: 13541107 · Received February 16, 2022

    Report

    Report Number
    9612164-2022-00635
    Event Type
    Injury
    Date Received
    February 16, 2022
    Date of Event
    June 18, 2021
    Report Date
    February 16, 2022
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED; LASER IN SITU FENESTRATION IN THORACIC ENDOVASCULAR AORTIC REPAIR: A SINGLE-CENTER ANALYSIS EVANS ET AL, ANN VASC SURG 2021; 76: 159¿167 HTTPS://DOI.ORG/10.1016/J.AVSG.2021.05.006: MEAN AGE, MEAN GENDER, AND EXACT DATE OF IMPLANT UNKNOWN. THERE WAS NO INFORMATION TO SUGGEST ANY MEDTRONIC DEVICE FAILURE CAUSED OR CONTRIBUTED TO A DEATH. DEATHS ARE COMMON OCCURRENCES HOWEVER THE CAUSE(S) OF DEATH ARE OFTEN NOT CHARACTERIZED OR CLEARLY ASSOCIATED WITH A PARTICULAR PRODUCT. THEREFORE, DEATHS WILL NOT BE CONSIDERED REPORTABLE AS MDR OR VIGILANCE UNLESS CLEARLY STATED AS BEING ASSOCIATED WITH MEDTRONIC PRODUCT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    UNKNOWN MEDTRONIC STENT GRAFTS WERE IMPLANTED IN PATIENTS DURING THE ENDOVASCULAR TEVAR WITH LASER IN SITU FENESTRATION (LISF) ON UNKNOWN DATES. NON MDT STENT GRAFTS WERE ALSO IMPLANTED. THE FOLLOWING ADVERSE EVENTS WERE REPORTED: BYPASS STENOSIS STROKE, SPINAL CORD ISCHEMIA, ACCESS SITE HEMATOMA, ARRHYTHMIAS, AKI, PNEUMONIA, THORACIC DUCT INJURY, MI, REINTERVENTION AND DEATH. THERE WAS NO INFORMATION TO SUGGEST ANY MEDTRONIC DEVICE FAILURE CAUSED OR CONTRIBUTED TO A DEATH. THE CAUSE OF THE ADVERSEEVENTS ARE UNDETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8759 UNK-CV-SR SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND UNK-CV-SR

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention