MAUDE Adverse Event Report: SIENTRA INC LIPOASPIRATE WASH SYSTEM; FAT TRANSFER

Model Number	VIALITY-1400
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare provider informed sientra that there was no mesh on one side of the viality unit's internal basket.It was completely missing.Once it was realized, that part of the mesh basket was missing, everything was harvested into a cannister and aborted the viality.
Additional Manufacturer Narrative
Sientra complaint #:(b)(4).Patient age defaulted to "(b)(6)" as patient information was not provided.Sientra will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Additional Manufacturer Narrative
Sientra complaint#: (b)(4).Device evaluation: g3, g6, h2, h3, h6, h10.Sientra received the suspected device from the customer and performed a failure analysis.The device was not returned for investigation; however, two pictures were sent of the missing mesh.The pictures of the mesh basket clearly substantiate the customer¿s reported issue.There is missing mesh on one side of the chamber assembly.The edhr was reviewed and the operator who assembled the mesh basket was identified.This operator is not available to speak to as they are not employed at tam.The process to assemble the mesh basket was reviewed as well.During this review it was discovered that the process step 26 for the mesh securement with an inspection.The root cause was found to be the operator error during the manufacturing of the chamber assembly.The mesh basket is built during the chamber assembly process, and the operator did not notice the mesh was missing.Sientra will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: LIPOASPIRATE WASH SYSTEM
• Common Device Name: FAT TRANSFER
• Manufacturer (Section D): SIENTRA INC; 3333 michelson dr; suite 650; irvine CA 92612
• Manufacturer (Section G): SIENTRA INC; 9646 s. 54th st.; franklin WI 53132
• Manufacturer Contact: denise dajles ; 8055628401
• MDR Report Key: 20028504
• Report Number: 1651189-2024-07458
• Device Sequence Number: 12903160
• Product Code: QKL
• UDI-Device Identifier: 00810076894621
• UDI-Public: 00810076894621
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P070004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2024

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 Model Number: VIALITY-1400
• Device Catalogue Number: VIALITY-1400
• Device Lot Number: A50476
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/18/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2024
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown