BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTIVA FLORA TISSUE EXPANDER CORSÉ MEDIUM HEIGHT 300 S

    MDR report key: 19137797 · Received April 18, 2024

    Report

    Report Number
    3012883202-2024-04176
    Event Type
    Injury
    Date Received
    April 18, 2024
    Date of Event
    March 14, 2024
    Report Date
    August 22, 2024
    Manufacturer
    MOTIVA USA LLC
    Product Code
    LCJ
    UDI-DI
    07445161017604
    PMA / PMN Number
    K211676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED DEVICE WAS RETURNED FOR EVALUATION, AND IT WAS CONFIRMED THAT THERE IS A RELATIONSHIP BETWEEN THE REPORTED EVENT AND THE DEVICE. UPON INITIAL VISUAL INSPECTION, A RUPTURE IN THE DEVICE WAS IDENTIFIED. A MORE DETAILED INSPECTION UNDER A MICROSCOPE REVEALED TRACE MARKS ON THE SHELL CONSISTENT WITH THOSE CAUSED BY A SHARP INSTRUMENT. THESE FINDINGS WERE REPLICATED IN OUR LABORATORY, DISTINGUISHING THEM FROM THE PATTERN TYPICALLY SEEN WITH SPONTANEOUS TEARS IN THE IMPLANT SHELL. ADDITIONALLY, ELONGATION TESTS CONFIRMED THAT THE SHELL MET INTERNATIONAL SPECIFICATION STANDARDS. A THOROUGH REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR LOT 22051365 WAS CONDUCTED, AND NO DEVIATIONS WERE FOUND IN THE MANUFACTURING PROCESS. THE COMPLAINT HISTORY FOR THE REPORTED LOT NUMBER AND STERILIZATION RUN WAS ALSO REVIEWED, WITH NO SIMILAR COMPLAINTS REPORTED IN THE PAST. THE DIRECTIONS FOR USE WERE REVIEWED TO DETERMINE IF THE INSTRUCTIONS PROVIDED ADEQUATE GUIDANCE FOR THE PREVENTION AND PROPER HANDLING OF THE PRODUCT. THE INFORMATION IN THE SURGICAL PRECAUTIONS SECTION IS CONSIDERED SUITABLE FOR ADDRESSING THIS EVENT. SPECIFICALLY, THE FOLLOWING INFORMATION IS PROVIDED REGARDING RUPTURE: RUPTURE: BREAST IMPLANTS CAN RUPTURE WHEN THE SHELL DEVELOPS A TEAR OR HOLE, WHICH MAY OCCUR AT ANY TIME AFTER IMPLANTATION, THOUGH THE LIKELIHOOD INCREASES OVER TIME. POTENTIAL CAUSES OF RUPTURE INCLUDE DAMAGE BY SURGICAL INSTRUMENTS, STRESS AND WEAKENING DURING IMPLANTATION, IMPLANT AGE AND DESIGN, SUBMUSCULAR RATHER THAN SUBGLANDULAR PLACEMENT, POST-OPERATIVE HEMATOMAS OR SEROMAS, FOLDING OR WRINKLING OF THE IMPLANT SHELL, EXCESSIVE FORCE TO THE CHEST, TRAUMA, COMPRESSION DURING MAMMOGRAPHIC IMAGING, AND SEVERE CAPSULAR CONTRACTURE. SILENT RUPTURES, WHERE NEITHER THE PATIENT NOR THE DOCTOR CAN DETECT A TEAR IN THE SHELL THROUGH PHYSICAL EXAMINATION, ARE COMMON WITH SILICONE GEL-FILLED IMPLANTS. HIGH-RESOLUTION ULTRASOUND (HRUS) IS A WIDELY ACCEPTED METHOD FOR DIAGNOSING RUPTURES, AND THE USFDA RECOMMENDS MRI SURVEILLANCE STARTING THREE YEARS POSTOPERATIVELY, WITH SUBSEQUENT MRIS EVERY TWO YEARS. THESE RECOMMENDATIONS MAY VARY BY COUNTRY, SO PATIENTS SHOULD BE PROVIDED WITH GUIDANCE BASED ON THEIR LOCAL STANDARDS OF CARE. ESTABLISHMENT LABS DOES NOT RECOMMEND CLOSED CAPSULOTOMY FOR TREATING CAPSULAR CONTRACTURE DUE TO THE RISK OF IMPLANT RUPTURE. SYMPTOMS SUCH AS LUMPS AROUND THE IMPLANT OR IN THE AXILLA, CHANGES IN BREAST OR IMPLANT SIZE OR SHAPE, PAIN, TINGLING, SWELLING, NUMBNESS, BURNING, OR HARDENING OF THE BREAST MAY INDICATE RUPTURE BUT CAN ALSO BE ASSOCIATED WITH CAPSULAR CONTRACTURE. IN SOME CASES, SILICONE IMPLANT LEAKAGE HAS BEEN LINKED TO EOSINOPHILIA AND SHOULD BE CONSIDERED IN THE DIFFERENTIAL DIAGNOSIS. GENERAL CONCLUSION: THE MOST LIKELY CAUSE OF THE REPORTED EVENT IS A CUT CAUSED BY A SHARP INSTRUMENT, WHICH COULD HAVE WEAKENED THE SHELL. ESTABLISHMENT LABS WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS AND TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT'S MEDICAL DEVICE WAS DETECTED TO HAVE DEFLATED.. ON (B)(6) 2024, SHE UNDERWENT A TISSUE EXPANDER REPLACEMENT SURGERY TO CONTINUE WITH THE EXPANSION PHASE OF HER TREATMENT. DURING A SUBSEQUENT INSPECTION, A NEEDLE PUNCTURE WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2258385 MOTIVA FLORA TISSUE EXPANDER CORSÉ MEDIUM HEIGHT 300 S MOTIVA FLORA TISSUE EXPANDER LCJ MOTIVA USA LLC 22051365 07445161017604

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other