BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MOTIVA FLORA TISSUE EXPANDER

    MDR report key: 19957351 · Received August 10, 2024

    Report

    Report Number
    3012883202-2024-00029
    Event Type
    Malfunction
    Date Received
    August 10, 2024
    Date of Event
    March 31, 2022
    Report Date
    August 10, 2024
    Manufacturer
    MOTIVA USA LLC
    Product Code
    LCJ
    PMA / PMN Number
    K211676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RUPTURE IS A COMMON AND KNOWN REASON FOR COMPLAINTS, AND IT IS CLEARLY CHARACTERIZED IN THE PRODUCT DFU INCLUDED WITH THE DEVICE, AS STATED ABOVE. THE INSTRUCTIONS FOR USE IN THE DIRECTIONS FOR USE WERE REVIEWED, TO DETERMINATE IF THERE ARE INDICATIONS THAT ENSURE THE PREVENTION AND GOOD HANDLING OF THE PRODUCT. FOR THIS EVENT, IT IS CONSIDERED THAT THE INFORMATION IS SUITABLE FOR THE SECTION OF SURGICAL PRECAUTIONS AS FOLLOWS: TISSUE EXPANDER RUPTURE/DEFLATION OCCURS WHEN THE SHELL DEVELOPS A TEAR OR A HOLE. RUPTURE/DEFLATION CAN OCCUR AT ANY TIME AFTER IMPLANTATION BUT INCREASES IN LIKELIHOOD THE LONGER THE BREAST TISSUE EXPANDER IS IN PLACE. THE FOLLOWING MAY CAUSE EXPANDERS TO RUPTURE/DEFLATE: DAMAGE BY SURGICAL INSTRUMENTS, DEVICE STRESS AND WEAKENING DURING IMPLANTATION, AGE AND DESIGN OF THE DEVICE, PLACEMENT, OCCURRENCE OF POST-OPERATORY HEMATOMAS OR SEROMAS, FOLDING OR WRINKLING OF THE EXPANDER'S SHELL, TRAUMA AND SEVERE CAPSULAR CONTRACTURE. EXPANDER DEFLATION MAY OCCUR IF THERE IS LEAKAGE OF SALINE SOLUTION WHEN INSERTING THE NEEDLE OUT OF THE INJECTION AREA DURING FILLING; ANOTHER POSSIBLE CAUSE IS A DAMAGED BREAST TISSUE EXPANDER ENVELOPE. ALSO, A COMPLETE REVIEW OF THE DHR COULD NOT BE CARRIED OUT SINCE NO DEVICE TRACEABILITY INFORMATION WAS PROVIDED. AT ESTABLISHMENT LABS, WE ARE COMMITTED TO PATIENT SAFETY AND CONTINUALLY EVALUATE THE PERFORMANCE OF OUR DEVICES THROUGH POSTMARKET SURVEILLANCE OF REPORTED COMPLAINTS & ADVERSE EVENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED IN THE SOCIAL SCIENCE RESEARCH NETWORK JOURNAL PUBLICATION "SMOOTH OPERATOR: NANOTEXTURED MRI-COMPATIBLE BREAST TISSUE EXPANDERS ARE ASSOCIATED WITH LOWER RATES OF CAPSULAR CONTRACTURE" THAT THREE PATIENTS EXPERIENCED A RUPTURE AFTER A BREAST RECONSTRUCTION USING FLORA TISSUE EXPANDER®. IT IS NOT REPORTED IF MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED TO SOLVE THE EVENT. ADDITIONAL FOLLOW UPS ARE BEING CONDUCTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2514034 MOTIVA FLORA TISSUE EXPANDER MOTIVA FLORA TISSUE EXPANDER LCJ MOTIVA USA LLC NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other