BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS ESHEATH SHEATH SET

    MDR report key: 25021558 · Received April 28, 2026

    Report

    Report Number
    2015691-2026-14779
    Event Type
    Injury
    Date Received
    April 28, 2026
    Report Date
    April 28, 2026
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYB
    PMA / PMN Number
    K200258
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: A CASE OF "HYDROPHILIC POLYMER EMBOLISM AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT MANAGEMENT AND TREATMENT" YUYA KOBAYASHI, MD, SATOSHI KAWAGUCHI, MD, YUYA KITANI, MD, AKIHO MINOSHIMA, MD, CHIAKI TAKAHASHI, MD, TOSHIHARU TAKEUCHI, MD, HIROYUKI KAMIYA, MD AND NAOKI NAKAGAWA, MD THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THE INFORMATION WAS OBTAINED THROUGH THE LITERATURE, "A CASE OF HYDROPHILIC POLYMER EMBOLISM AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT". A TRANSFEMORAL TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) USING AN (SAPIEN 3) S3 VALVE WAS PERFORMED. ON POSTOPERATIVE DAY 4 (POD4), A DECLINE IN ESTIMATED GLOMERULAR FILTRATION RATE (EGFR) ACCOMPANIED BY DECREASED URINE OUTPUT WAS OBSERVED. POD6, PAINFUL PETECHIAL PURPURA DEVELOPED ON THE RIGHT LOWER EXTREMITY AND DORSUM OF THE FOOT. HISTOPATHOLOGICAL EXAMINATION REVEALED HYDROPHILIC POLYMER EMBOLI WITHIN DERMAL CAPILLARIES, LEADING TO A DIAGNOSIS OF CATHETER-RELATED HYDROPHILIC POLYMER EMBOLISM (HPE). METHYLPREDNISOLONE THERAPY WAS INITIATED ON POD6, RESULTING IN RAPID IMPROVEMENT OF THE PETECHIAL PURPURA AS WELL AS RECOVERY FROM ACUTE KIDNEY INJURY. THE DOSE OF METHYLPREDNISOLONE WAS GRADUALLY TAPERED AND DISCONTINUED; THE SKIN LESIONS COMPLETELY RESOLVED BY POD18, AND THE PATIENT WAS DISCHARGED ON POD35. DURING REGULAR FOLLOW-UP AFTER DISCHARGE, NO DETERIORATION IN RENAL FUNCTION WAS OBSERVED AFTER CESSATION OF METHYLPREDNISOLONE, AND NO RECURRENCE WAS NOTED THROUGHOUT A FIVE-YEAR FOLLOW-UP PERIOD. IN THE CURRENT CASE, CALCIFICATION NEAR THE RIGHT FEMORAL ACCESS SITE WAS PROMINENT, WITH RASHES OBSERVED ON THE IPSILATERAL LOWER LIMB. THEREFORE, HPE LIKELY OCCURRED DURING THE INSERTION OF THE EXPANDABLE SHEATH OR ITS EXPANSION BY A VALVE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1075388 EDWARDS ESHEATH SHEATH SET INTRODUCER, CATHETER DYB EDWARDS LIFESCIENCES 914ESJ

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Male Required Intervention