BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTIVA FLORA TISSUE EXPANDER

    MDR report key: 19149488 · Received April 19, 2024

    Report

    Report Number
    3012883202-2024-04180
    Event Type
    Injury
    Date Received
    April 19, 2024
    Date of Event
    October 2, 2023
    Report Date
    November 13, 2024
    Manufacturer
    MOTIVA USA LLC
    Product Code
    LCJ
    PMA / PMN Number
    K211676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DFU REVISION: THE INSTRUCTIONS FOR USE IN THE DIRECTIONS FOR USE WERE REVIEWED TO DETERMINE 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 ON THE SECTION OF SURGICAL PRECAUTIONS AS FOLLOWS: RUPTURE/DEFLATION. 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 WAS CARRIED OUT, NO DEVIATION WAS FOUND IN THE PROCESS, SO IT IS ESTABLISHED THAT THERE IS NO EVIDENCE OF A RELATIONSHIP BETWEEN THE EVENT AND THE MANUFACTURING PROCESS. - SHELL MANUFACTURING: NO DEVIATION OR ABNORMALITY DETECTED; - GEL MIXING: NO DEVIATION OR ABNORMALITY DETECTED; - PRIMARY PACKAGING: NO DEVIATION OR ABNORMALITY DETECTED; - STERILIZATION: NO DEVIATION OR ABNORMALITY DETECTED; - SECOND STERILIZATION ROUND: NO DEVIATION OR ABNORMALITY DETECTED; - SECONDARY PACKAGING: NO DEVIATION OR ABNORMALITY DETECTED; - LABELING: NO DEVIATION OR ABNORMALITY DETECTED. ADDITIONALLY, RUPTURE IS A COMMON AND KNOWN REASON FOR COMPLAINTS, AND IT IS CLEARLY CHARACTERIZED IN THE PRODUCT DFU INCLUDED WITH THE IMPLANT, AS STATED ABOVE.

    Additional Manufacturer Narrative · 0

    THE REPORTED DEVICE WAS RETURNED FOR EVALUATION. THERE WAS A RELATIONSHIP BETWEEN THE REPORTED RUPTURE (LEAK) AND THE DEVICE. THE INITIAL VISUAL INSPECTION FOUND A DEVICE RUPTURE. MICROSCOPE INSPECTION SHOWED TRACE MARKS IN THE SHELL CONSISTENT WITH THOSE OF A SHARP INSTRUMENT REPRODUCED IN OUR LABORATORY, THIS IS DISTINCT FROM THE PATTERN RESULTING FROM A SPONTANEOUS TEAR IN THE SHELL OF THE IMPLANT. ELONGATION TESTS CONFIRMED THE SHELL COMPLIED WITH THE INTERNATIONAL SPECIFICATION STANDARDS. A COMPLETE REVIEW OF THE DHR FOR LOT: 21120009 WAS CARRIED OUT, NO DEVIATION WAS FOUND IN THE MANUFACTURING PROCESS. REVIEW OF COMPLAINT HISTORY FOR THE REPORTED LOT NUMBER AND STERILIZATION RUN FOUND NO OTHER SIMILAR COMPLAINTS REPORTED IN THE PAST. 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: RUPTURE/DEFLATION - 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. IN CONCLUSION, IT WAS DETERMINED THAT A PROBABLE CAUSE FOR THE RUPTURE REPORTED WAS A CUT RESULTING FROM A SHARP INSTRUMENT USED WHICH COULD HAVE WEAKENED THE SHELL. ESTABLISHMENT LABS WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS/TRENDS.

    Description of Event or Problem · 0

    ON OCTOBER 2ND WE'VE NOTICED THAT THE TISSUE EXPANDER WAS LEAKING (FLATTER THEN THE OTHER SIDE). WE'VE REMOVED IT ON OCTOBER 10TH AND REPLACED IT BY A NEW ONE.

    Description of Event or Problem · 0

    ON (B)(6), WE'VE NOTICED THAT THE TISSUE EXPANDER WAS LEAKING (FLATTER THEN THE OTHER SIDE). WE'VE REMOVED IT ON (B)(6) AND REPLACED IT BY A NEW ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035749 MOTIVA FLORA TISSUE EXPANDER MOTIVA FLORA TISSUE EXPANDER LCJ MOTIVA USA LLC 21120009

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other