BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTIS SINGLE INCISION SLING SYSTEM

    MDR report key: 20836325 · Received December 3, 2024

    Report

    Report Number
    2125050-2024-02005
    Event Type
    Malfunction
    Date Received
    December 3, 2024
    Date of Event
    November 18, 2024
    Report Date
    February 25, 2025
    Manufacturer
    COLOPLAST A/S
    Product Code
    PAH
    UDI-DI
    05701780274807
    PMA / PMN Number
    K121562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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 WERE IDENTIFIED IN VEEVA. THERE WERE SEVERAL COMPLAINTS IDENTIFIED AGAINST THIS LOT: HOWEVER, WITH VARIOUS FAILURE MODES. THEREFORE, THIS IS NOT CONSIDERED A TREND. A PREVENTATIVE CAPA (CAPA-000303) HAS BEEN HISTORICALLY OPENED FOR THE ALTIS PRODUCT LINE TO INVESTIGATE INCREASED RATES OF MESH TO SUTURE OR ANCHOR TO SUTURE BOND FAILURES WHICH IS BEING REPORTED IN THIS COMPLAINT. DEVICES MET SPECIFICATION PRIOR TO RELEASE.

    Additional Manufacturer Narrative · 0

    AN ALTIS MESH AND DYNAMIC SUTURE WERE RECEIVED FOR EVALUATION. EXAMINATION OF THE MESH REVEALED THAT THE STATIC ANCHOR AND SUTURE WERE DETACHED AND NOT RETURNED. EXAMINATION OF THE STATIC END OF THE MESH REVEALED THE MESH TO HAVE CURLED WITH MONOFILAMENT EXTRUDING, INDICATING THE MESH MAY HAVE BEEN PULLED, MOST LIKELY DURING REMOVAL. EXAMINATION OF THE DYNAMIC SIDE OF THE MESH REVEALED THE DYNAMIC SUTURE WAS DETACHED. EXAMINATION OF THE DETACHED DYNAMIC SUTURE & ANCHOR REVEALED THAT THE DYNAMIC ANCHOR AND TENSIONER WERE NEAR THE DYNAMIC SUTURE CLOSE TO THE MESH. MICROSCOPIC EXAMINATION OF THE DYNAMIC ANCHOR REVEALED THE TINES TO BE BENT OUTWARD WITH TISSUE NOTED IN THE ANCHOR. BLOOD RESIDUE WAS NOTED ON THE MESH AND DYNAMIC ANCHOR. BASED ON THE INFORMATION RECEIVED, AND EXAMINATION OF THE RETURNED PRODUCT, A DETACHMENT OF THE DYNAMIC SUTURE FROM THE MESH OCCURRED. IT WAS NOTED THAT THE DYNAMIC ANCHOR AND TENSIONER WERE NEAR THE MESH WHEN RECEIVED. IT WAS CONCLUDED THAT DURING THE TENSIONING PROCESS THE DYNAMIC ANCHOR SHOULD BE NEARER THE MESH AREA THAN THE SUTURE LOOP AREA. THEREFORE, QUALITY CONCLUDED THAT THE DYNAMIC ANCHOR MAY NOT HAVE BEEN PLACED IN THE CORRECT LOCATION DURING IMPLANT, WHICH RESULTED IN THE ANCHOR COMING OUT OF THE TISSUE. 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 STRAP OF THE DEVICE IS TORN. NO ADDITIONAL PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION, THE STRAP OF THE DEVICE IS TORN. NO ADDITIONAL PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1543406 ALTIS SINGLE INCISION SLING SYSTEM FEMALE STRESS URINARY INCONTINENCE SURGICAL MESH-SLING, SYNTHETIC POLYMER PAH COLOPLAST A/S 9303735_5196504022 05701780274807

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other