BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALTIS SINGLE INCISION SLING SYSTEM

    MDR report key: 20623003 · Received November 6, 2024

    Report

    Report Number
    2125050-2024-01818
    Event Type
    Malfunction
    Date Received
    November 6, 2024
    Date of Event
    October 21, 2024
    Report Date
    May 28, 2025
    Manufacturer
    COLOPLAST A/S
    Product Code
    PAH
    UDI-DI
    05708932467407
    PMA / PMN Number
    K121562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE LOT NUMBER WAS REVIEWED FOR COMPLAINT TREND, NONCONFORMING REPORT, AND CAPA. NO CAPAS WERE IDENTIFIED. THERE WERE NO NON-CONFORMING REPORTS FOR THIS LOT NUMBER RELATED TO THE FAILURE BEING REPORTED IN THE COMPLAINT. 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. THE DEVICE WAS NOT RETURNED FOR EVALUATION. WITHOUT THE BENEFIT OF ANALYZING THE DEVICE, COLOPLAST CANNOT COMMENT ON THE CONDITION OF THE DEVICE. SHOULD ADDITIONAL INFORMATION PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OR CONCLUSIONS CONTAINED IN THIS REPORT, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    A PARTIAL ALTIS MESH AND DETACHED DYNAMIC SUTURE WERE RECEIVED FOR EVALUATION. EXAMINATION OF THE STATIC SIDE OF THE SLING REVEALED STRAIGHT EDGES IN A ¿V¿ FORMATION, INDICATING THE STATIC END OF THE MESH MOST LIKELY WAS CUT WITH A SHARP INSTRUMENTATION TO REMOVE. EXAMINATION OF THE SLING REVEALED PART OF THE DYNAMIC SUTURE WAS DETACHED FROM THE MESH. MICROSCOPIC EXAMINATION OF THE MESH WHERE THE DYNAMIC SUTURE WAS ATTACHED CONFIRMED THE WELDED AREA OF THE SUTURE. EXAMINATION OF THE DETACHED DYNAMIC SUTURE REVEALED THAT THE DYNAMIC ANCHOR AND TENSIONER WERE MISSING. 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 ANCHOR OCCURRED DURING THE TENSIONING PROCESS 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. IT WAS REPORTED THAT THE SLING WOULD NOT TENSION DOWN APPROPRIATELY. 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 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 DEVICE WOULD NOT TENSION DOWN APPROPRIATELY. A NEW ALTIS SLING WAS USED AND THE IMPLANT WAS SUCCESSFUL.

    Description of Event or Problem · 0

    ACCORDING TO THE AVAILABLE INFORMATION, THE DEVICE WOULD NOT TENSION DOWN APPROPRIATELY. A NEW ALTIS SLING WAS USED AND THE IMPLANT WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1859868 ALTIS SINGLE INCISION SLING SYSTEM FEMALE STRESS URINARY INCONTINENCE SURGICAL MESH-SLING, SYNTHETIC POLYMER PAH COLOPLAST A/S 9112857_5196502400 05708932467407

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female