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

Catalog Number	H-13-145
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
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.).However, for this specific case, we do not have concrete information regarding whether the units will be returned.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.It has been alleged that some patients implanted with motiva flora tissue expander lot number 25031568 are experiencing leaks.At this time, it is unknown which serial number corresponds to each patient or the specific outcome of the issue.Efforts to obtain additional information are ongoing, and the investigation remains in progress.
Additional Manufacturer Narrative
The serial number is being included since it was captured after the initial report was sent.
Additional Manufacturer Narrative
Laboratory testing could not be performed as the device was not returned for evaluation.In the absence of the physical product, it was not possible to apply the defined test methods or conduct any material or functional analysis in accordance with standard procedures.Based on the investigation performed, the event could not be confirmed, and no definitive root cause could be identified.The event has been evaluated as part of ongoing trend analysis activities within the pms program.Per the current complaint data report: no adverse or unexpected trends related to the alleged event have been identified.No further corrective or preventive actions are required at this time.Establishment labs will continue to monitor for similar events as part of routine pms surveillance.

• 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: 23666270
• Report Number: 3012883202-2025-01523
• Device Sequence Number: 8910723
• Product Code: LCJ
• UDI-Device Identifier: 07445161020956
• UDI-Public: (01)07445161020956(11)250320(17)270320
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K211676
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/27/2025

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 Catalogue Number: H-13-145
• Device Lot Number: 25031568
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 11/27/2025
• Supplement Report FDA Received Date: 01/29/2026; 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/20/2025
• 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: Required Intervention
• Patient Sex: Unknown