BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEE H10

    MDR report key: 3743318 · Received April 11, 2014

    Report

    Report Number
    2015691-2014-00849
    Event Type
    Injury
    Date Received
    April 11, 2014
    Date of Event
    March 12, 2014
    Report Date
    March 12, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT SOLD OR MARKETED IN THE UNITED STATES; HOWEVER, IT IS SIMILAR TO THE BRAND CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS, MODEL# 2800, PMA# P860057/S001. (B)(4) - STENT CREEP. METHOD: DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: ARTICLE CONCLUSIONS: STENT CREEP CAN OCCUR IN MODERN BIOPROSTHESES AND ANY PATIENT PRESENTING WITH SYMPTOMS AND AN INCREASING MIDVALVULAR GRADIENT ON ECHOCARDIOGRAPHY ESPECIALLY EARLY POST VALVE SURGERY SHOULD BE SUSPECTED OF THIS MODE OF VALVE FAILURE. V-IN-V TAVI REPRESENTS A NOVEL METHOD OF IMPROVING OUTCOMES FOR THIS MODE OF VALVE DEGENERATION IN HIGH-RISK PATIENTS.

    Description of Event or Problem · 1

    EDWARDS WAS INFORMED THROUGH AN ARTICLE THAT THIS PATIENT UNDERWENT A VALVE-IN-VALVE (VIV) PROCEDURE DUE TO STENOSIS PREDOMINANTLY DUE TO STENT CREEP. NO ADDITIONAL INFORMATION ON EXACT MODEL AND SERIAL NUMBER IS PROVIDED IN THIS ARTICLE. SEE ATTACHED ARTICLE ¿SUCCESSFUL TREATMENT OF FAILING BIOLOGICAL PROSTHESIS DUE TO ¿STENT CREEP¿ WITH VALVE-IN-VALVE TRANSCATHETER AORTIC VALVE IMPLANTATION.¿ ABSTRACT: ¿INTRODUCTION: STENT CREEP IS AN UNCOMMON MODE OF STRUCTURAL DETERIORATION OF BIOPROSTHETIC HEART VALVES DEFINED BY A PERMANENT INWARD DEFLECTION OF THE STENT POSTS. THIS MAY OCCUR DUE TO VALVE OVER-SIZING AND LEADS TO INTRINSIC VALVE STENOSIS. IT HAS BEEN DESCRIBED IN OLDER GENERATION OF BIOPROSTHESIS AND WAS THOUGHT NOT TO OCCUR IN MODERN DEVICES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225862 SEE H10 REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| R