BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-X PROSTHETIC HEART VALVES

    MDR report key: 5420058 · Received February 9, 2016

    Report

    Report Number
    1649833-2016-70004
    Event Type
    Malfunction
    Date Received
    February 9, 2016
    Report Date
    April 27, 2021
    Manufacturer
    ON-X LIFE TECHNOLOGIES, INC.
    Product Code
    DYE
    UDI-DI
    00851788001457
    PMA / PMN Number
    P000037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    AS PER THE REQUEST SUBMITTED BY FDA MEDWATCH PROGRAM, THIS REPORT IS BEING RESUBMITTED AS REPORT NUMBER 1649833-2016-70004-1. THIS REPORT PREVIOUSLY WAS SUBMITTED AS 1649833-2015-70025-1, FEBRUARY 9, 2016. DESCRIPTION FROM ORIGINAL FOLLOW-UP MEDWATCH REPORT AS FOLLOWS: THIS IS A FOLLOW-UP REPORT TO THE ORIGINAL MDR NO. 1649833-2015-70025-1. EVENT OCCURRED IN (B)(6). ORIGINAL REPORT STATED: "DISTRIBUTOR IN B)(4) NOTIFIED ONXLTI THAT THE SEWING RING STITCHING WAS UNRAVELING. THE CONDITION WAS NOTICED AT THE BEGINNING OF THE SURGERY. THE VALVE WILL BE RETURNED TO ONXLTI FOR INVESTIGATION". THE VALVE HAS BEEN RETURNED AND EVALUATED. THIS VALVE IS VERY SIMILAR TO PAST OCCURRENCES OF THIS TYPE WHICH HAVE BEEN ATTRIBUTED TO IATROGENIC DAMAGE, WHERE THE SURGEON'S NEEDLE PATH WAS TOO CLOSE TO THE VALVE BODY WHERE THE SEWING RING CONSTRUCTION SUTURE IS LOCATED, CUTTING THE CONSTRUCTION SUTURE, AND ALLOWING IT TO UNRAVEL AS FAR AS 4 STITCHES UP TO THE POINT A THE STOP KNOT. UNRAVELING DOES NOT PROGRESS BEYOND THE STOP KNOT, IT IS CONCLUDED THAT THE VALVE DID NOT MALFUNCTION, IT WAS DAMAGED BY USER ERROR. THE IFU IS CLEAR ON INSTRUCTIONS ABOUT NEEDLE PATH IN THE SEWING RING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83401 ON-X PROSTHETIC HEART VALVES MECHANICAL HEART VALVE, PRODUCT CODE: DYE DYE ON-X LIFE TECHNOLOGIES, INC. ONXACE 00851788001457

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention