BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTIS SINGLE INCISION SLING SYSTEM

    MDR report key: 19351940 · Received May 20, 2024

    Report

    Report Number
    2125050-2024-00779
    Event Type
    Malfunction
    Date Received
    May 20, 2024
    Date of Event
    April 25, 2024
    Report Date
    August 22, 2024
    Manufacturer
    COLOPLAST A/S
    Product Code
    PAH
    UDI-DI
    05708932467407
    PMA / PMN Number
    K121562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE LOT NUMBER WAS REVIEWED FOR COMPLAINT TREND, NONCONFORMING REPORT, AND CAPA. NO NCS NOR CAPAS WERE IDENTIFIED IN VEEVA. THERE WERE SEVERAL COMPLAINTS IDENTIFIED AGAINST THIS LOT; HOWEVER, WITH VARIOUS FAILURE MODES. THEREFORE, THIS IS NOT CONSIDERED A TREND. DEVICES MET SPECIFICATION PRIOR TO RELEASE.

    Additional Manufacturer Narrative · 0

    AN ALTIS SLING WAS RECEIVED FOR EVALUATION. EXAMINATION OF THE SLING REVEALED THE STATIC ANCHOR ATTACHED TO THE MESH. MICROSCOPIC EXAMINATION OF THE MESH WHERE THE DYNAMIC SUTURE WAS ATTACHED CONFIRMED THE WELDED AREA OF THE SUTURE. MICROSCOPIC EXAMINATION OF THE MESH ON THE DYNAMIC SIDE REVEALED ROUGH AND IRREGULAR SURFACES, INDICATING STRESS MAY HAVE BEEN EXERTED. THE DYNAMIC ANCHOR AND TENSIONER WERE NOT RECEIVED. BLOOD RESIDUE WAS NOTED ON THE MESH. THE INFORMATION RECEIVED INDICATED THE DYNAMIC SUTURE DETACHED DURING THE PROCEDURE. QUALITY CONFIRMED THE DETACHED DYNAMIC SUTURE. AS THE DYNAMIC ANCHOR AND TENSIONER WERE NOT RECEIVED, IT WAS CONCLUDED THAT THE DETACHMENT OF THE DYNAMIC SUTURE MOST LIKELY OCCURRED DURING THE TENSIONING PART OF THE PROCEDURE. DETAILS WERE NOT PROVIDED IF THERE WERE ANY ISSUES THAT MAY HAVE OCCURRED PRIOR TO THE DETACHMENT. AS THE DETACHMENT ENDS OF THE DYNAMIC SUTURE WERE ROUGH AND IRREGULAR, THIS INDICATED THAT EXCESS STRESS WAS MOST LIKELY EXERTED TO RESULT IN THE SEPARATION NOTED. A REVIEW OF THE DEVICE HISTORY RECORD BY THE CONTRACT MANUFACTURER CONFIRMED THE DEVICES FROM THIS LOT MET ALL SPECIFICATIONS PRIOR TO RELEASE. A REVIEW OF THE COMPLAINT HISTORY DATABASE, NONCONFORMANCES AND CAPAS REVEALED NO TRENDS FOR THIS LOT.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION THE SURGEON WAS IMPLANTING THE DEVICE AND THE SUTURE BROKE AT THE DYNAMIC ANCHOR SPOT. NO ADVERSE PATIENT EVENTS WERE REPORTED.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION THE SURGEON WAS IMPLANTING THE DEVICE AND THE SUTURE BROKE AT THE DYNAMIC ANCHOR SPOT. NO ADVERSE PATIENT EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1672758 ALTIS SINGLE INCISION SLING SYSTEM FEMALE STRESS URINARY INCONTINENCE SURGICAL MESH-SLING, SYNTHETIC POLYMER PAH COLOPLAST A/S 9066455_5196502400 05708932467407

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other