BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOTIVA FLORA TISSUE EXPANDER

    MDR report key: 20297532 · Received September 24, 2024

    Report

    Report Number
    3012883202-2024-00033
    Event Type
    Injury
    Date Received
    September 24, 2024
    Date of Event
    May 28, 2024
    Report Date
    September 24, 2024
    Manufacturer
    MOTIVA USA LLC
    Product Code
    LCJ
    UDI-DI
    07445161017567
    PMA / PMN Number
    K211676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS STATED IN THE LITERATURE ¿THE HUMAN BREAST IS NOT A STERILE ANATOMIC STRUCTURE; IT CONTAINS ENDOGENOUS FLORA, DERIVED FROM THE NIPPLE DUCTS, THAT IS ESSENTIALLY SIMILAR TO THAT FOUND IN NORMAL SKIN. MULTIPLE BREAST DUCTS PROVIDE A PASSAGE FROM THE SKIN SURFACE TO DEEP WITHIN THE BREAST TISSUE¿. (PITTET ET AL, 2005) TO DATE, MOTIVA FLORA TISSUE EXPANDER HAS NOT RECEIVED, THEREFORE AN ANALYSIS OF THE DEVICE COULD NOT BE COMPLETED. ADDITIONAL ATTEMPTS TO GET MORE INFORMATION IS ONGOING AND THE INVESTIGATION IS IN PROCESS. INFECTION IS A KNOWN RISK OF IMPLANTATION WITH TISSUE EXPANDERS AND IT IS DOCUMENTED IN THE MOTIVA FLORA TISSUE EXPANDER DIRECTIONS FOR USE (DOC-037),AS FOLLOWS: "RISK OF A PERIPROSTHETIC INFECTION MAY BE INCREASED AS RESULT OF AN ACTIVE INFECTION. DO NOT EXPOSE THE TISSUE EXPANDER OR INJECTION NEEDLES TO CONTAMINANTS, WHICH INCREASE THE RISK OF INFECTION. PATIENTS WHO PRESENT WOUND DEHISCENCE, TISSUE EROSION, ISCHEMIA OR NECROSIS HAVE AN INCREASED RISK OF PERIPROSTHETIC INFECTION. DURING SURGERY, PROTECTIVE MEASURES MUST BE TAKEN TO AVOID POSSIBLE INFECTION OF THE AREA. INFECTIONS CAN COMPROMISE THE EXPANSION PROCESS, THEREFORE, ANY SYMPTOMS THAT OCCUR, SUCH AS TENDERNESS, FLUID ACCUMULATION, PAIN OR FEVER, MUST BE REPORTED TO THE SURGEON AS SOON AS POSSIBLE TO BE AGGRESSIVELY TREATED AND THUS AVOID SERIOUS COMPLICATIONS. PREMATURE TISSUE EXPANDER REMOVAL MAY BE REQUIRED IF THE INFECTION DOES NOT RESPOND TO TREATMENT, OR IN THE CASE OF A NECROTIZING INFECTION". IN ADDITION, A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED, AND IT WAS CONCLUDED THAT THERE WERE NO DEVIATIONS IN THE MANUFACTURING PROCESS OF THIS DEVICE THAT WOULD HAVE CAUSED OR CONTIBUTED TO THIS INCIDENT. WHEN THE INVESTIGATION PROCESS IS COMPLETED THE APPLICABLE FINDINGS WILL BE INCLUDED IN A SUPPLEMENTAL MEDWATCH.

    Additional Manufacturer Narrative · 0

    QUALITY DEPARTMENT RECEIVED A COMPLAINT FROM A CUSTOMER, NOTIFYING ¿INFECTION¿. THE DEVICE INVOLVED CORRESPONDS TO A MOTIVA FLORA TISSUE EXPANDER, SERIAL NUMBER (B)(6), CATALOG NUMBER XMF-62. DHR REVIEW: A COMPLETE REVIEW OF THE DHR FOR LOT 22100107 WAS CARRIED OUT, AND NO DEVIATION WAS FOUND IN THE MANUFACTURING PROCESS. A REVIEW OF COMPLAINT HISTORY FOR THE REPORTED LOT NUMBER AND STERILIZATION RUN FOUND NO OTHER SIMILAR COMPLAINTS REPORTED IN THE PAST. DFU REVIEW: 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 FOR THE SECTION OF SURGICAL PRECAUTIONS AS FOLLOWS: "RISK OF A PERIPROSTHETIC INFECTION MAY BE INCREASED AS RESULT OF AN ACTIVE INFECTION. DO NOT EXPOSE THE TISSUE EXPANDER OR INJECTION NEEDLES TO CONTAMINANTS, WHICH INCREASE THE RISK OF INFECTION. PATIENTS WHO PRESENT WOUND DEHISCENCE, TISSUE EROSION, ISCHEMIA OR NECROSIS HAVE AN INCREASED RISK OF PERIPROSTHETIC INFECTION. DURING SURGERY, PROTECTIVE MEASURES MUST BE TAKEN TO AVOID POSSIBLE INFECTION OF THE AREA. INFECTIONS CAN COMPROMISE THE EXPANSION PROCESS, THEREFORE, ANY SYMPTOMS THAT OCCUR, SUCH AS TENDERNESS, FLUID ACCUMULATION, PAIN OR FEVER, MUST BE REPORTED TO THE SURGEON AS SOON AS POSSIBLE TO BE AGGRESSIVELY TREATED AND THUS AVOID SERIOUS COMPLICATIONS. PREMATURE TISSUE EXPANDER REMOVAL MAY BE REQUIRED IF THE INFECTION DOES NOT RESPOND TO TREATMENT, OR IN THE CASE OF A NECROTIZING INFECTION". AS STATED IN THE LITERATURE: ¿THE HUMAN BREAST IS NOT A STERILE ANATOMIC STRUCTURE; IT CONTAINS ENDOGENOUS FLORA, DERIVED FROM THE NIPPLE DUCTS, THAT IS ESSENTIALLY SIMILAR TO THAT FOUND IN NORMAL SKIN. MULTIPLE BREAST DUCTS PROVIDE A PASSAGE FROM THE SKIN SURFACE TO DEEP WITHIN THE BREAST TISSUE¿. (PITTET ET AL, 2005). CONCLUSION: INTERNAL INVESTIGATION WAS GENERATED, IT WAS NOT POSSIBLE TO CONFIRMED THE ALLEGED EVENT DUE TO INSUFFICIENT CLINICAL EVIDENCE. INFECTION IS CONSIDERED A POTENTIAL RISK OF THE SURGERY AS INDICATED IN THE PRODUCT DIRECTIONS FOR USE. ESTABLISHMENT LABS WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS/TRENDS. AS PART OF THE POST MARKET SURVEILLANCE PROCESS, MONITORING OF THE PRIMARY ENDPOINTS REPORTED IS PERFORMED TO DETERMINE UNFAVORABLE TRENDS. PER OUR CURRENT COMPLAINT DATA REPORT, NO UNFAVORABLE TRENDS WERE DETECTED ON THIS PRODUCT. NO FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN ACUTE INFECTION WITH SCEDOSPORIUM APIOSPERMUM, REQUIRING REMOVAL 1 MONTH POST IMPLANTATION. THE SPECIFIC PATIENT DEMOGRAPHICS SUCH AS AGE, WEIGH, ETHNICITY, ETC HAS NOT BEEN PROVIDED BY THE REPORTER. ADDITIONAL FOLLOW UPS ARE BEING CONDUCTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2248598 MOTIVA FLORA TISSUE EXPANDER MOTIVA FLORA TISSUE EXPANDER LCJ MOTIVA USA LLC 22100107 07445161017567

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention