BEUDAMED
    FDA Adverse Event Death Summary report: N

    WRAPSODY¿

    MDR report key: 25218237 · Received May 19, 2026

    Report

    Report Number
    1721504-2026-00053
    Event Type
    Death
    Date Received
    May 19, 2026
    Date of Event
    February 24, 2026
    Report Date
    May 19, 2026
    Manufacturer
    MERIT MEDICAL SYSTEMS INC.
    Product Code
    PFV
    PMA / PMN Number
    P240023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION. A FOLLOW-UP WILL BE SUBMITTED WHEN THE INVESTIGATION AND PRODUCT HISTORY REVIEW ARE COMPLETED.

    Description of Event or Problem · 0

    THE REPORTED CLINICAL TRIAL INVOLVES A DEATH CONSIDERED TO BE TARGET LESION RELATED AND NOT RELATED TO DEVICE OR PROCEDURE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308533 WRAPSODY¿ SYSTEM, ENDOVASCULAR GRAFT, ARTERIOVENOUS (AV) DIALYSIS ACCESS CIRCUIT STENOSIS PFV MERIT MEDICAL SYSTEMS INC. H3207544

    Patients

    Seq Age Sex Outcome Treatment
    1