MAUDE Adverse Event Report: ESTABLISHMENT LABS S.A. FLORA TISSUE EXPANDER SMOOTHSILK

Catalog Number	M-12-375
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The alleged event is a risk associated with breast surgery, and there is no evidence to suggest a link between this particular implant and/or its manufacturing process and a higher risk of occurrence.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 on surgical precautions as follows: patients should be advised that tissue expanders may deflate and require replacement surgery.Tissue-expander deflation occurs when saline solution leaks through a break or damaged shell or injection port.Rupture/deflation can occur at any time after implantation, but the likelihood increases the more prolonged the breast-tissue expander is in place.Deflation occurs immediately or progressively and is noted by the loss of size/shape of the device.Establishment labs requested the motiva flora ® te in order to test the unit to determine the most assignable cause, including but not limited to: revision and characterization of the failure, testing according to approved standards, etc.).A complete review of the dhr for lot involved was carried out, no deviation was found in the manufacturing process.Additionally, there were no indications of abnormalities in raw materials or manufacturing processes which may have affected this particular batch.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.
Event or Problem Description
Usa.Allegedly, a leak was found in a tissue explander on the 3rd post op visit to the clinic.In that follow-up visit, her left reconstructed breast was found to have less volume than the right, and the patient reported increased drainage output on the ipsilateral side.No patient demographics, such as weight, or ethnicity, were provided by the reporter.Efforts to gather additional information are ongoing, and the investigation remains in progress.

• Brand Name: FLORA TISSUE EXPANDER SMOOTHSILK
• Common Device Name: FLORA TISSUE EXPANDER SMOOTHSILK
• Manufacturer (Section D): ESTABLISHMENT LABS S.A.; building b-25, coyol free zone; alajuela,alajuela
• Manufacturer (Section G): ESTABLISHMENT LABS S.A.; building b-25, coyol free zone; alajuela,alajuela
• Manufacturer Contact: susana hidalgo ; building b-25, coyol free zone; alajuela,alajuela ; 8003554164
• MDR Report Key: 23660323
• Report Number: 3012883202-2025-01518
• Device Sequence Number: 10123722
• Product Code: LCJ
• UDI-Device Identifier: 07445161020895
• UDI-Public: (01)07445161020895(11)240311(17)260311
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/11/2026
• Device Catalogue Number: M-12-375
• Device Lot Number: 24030346
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/11/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female