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

Model Number	VIALITY-1400
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sientra complaint #: (b)(4).Patient age defaulted to 99 as no patient information was provided.Sientra was unable to perform an evaluation as the device was discarded by the customer.Sientra will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.H3 other text : device discarded.
Event or Problem Description
Doctor performed a re-construction case using viality and he could not get suction to work to the strength he needed it.They tried to push down the access cap and still were told nothing was helping.Customer ended up using another unit and everything worked fine.
Additional Manufacturer Narrative
Sientra complaint#: (b)(4).Sientra was able to perform investigation on lot/batch retained by the manufacturer and determined by r&d that the a-ring can become twisted when the device was under vacuum or can move during setup/transportation.Loss of vacuum or inability to generate vacuum leads to no risks of patient safety.The gasket design was updated to be an off the shelf round a-ring instead of a custom square gasket.Engineering study (b)(4) was performed and showed improvement in vacuum cycling.New design was implemented on (b)(6) 2023.It is most likely the root cause was the a-ring was out of position or possibly twisted not allowing for the lid to sit flush.This is a known issue and has been addressed.Sientra will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: VIALITY¿ 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; 3333 michelson dr; suite 650; irvine CA 92612
• Manufacturer Contact: denise dajles ; 8055628401
• MDR Report Key: 17272991
• Report Number: 1651189-2023-05085
• Device Sequence Number: 3566932
• Product Code: QKL
• UDI-Device Identifier: 00810076894621
• UDI-Public: 00810076894621
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: BK190433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2023

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
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/15/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2023
• Supplement Date Received by Manufacturer: 01/09/2024
• Initial Report FDA Received Date: 07/06/2023
• Supplement Report FDA Received Date: 02/01/2024
• 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