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

Model Number	VIALITY-1400
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Sientra complaint #: (b)(4).At this time, the suspect device has not been returned for evaluation.Sientra will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Event or Problem Description
The side of the viality unit cracked horizontally during surgery.
Additional Manufacturer Narrative
Sientra complaint#: (b)(4).Device evaluation: g3, g6, h2, h3, h6, h10.Manufacturer provided investigation result: the device was tested to iso 10079 which specifies that containers must be tested to 95kpa for implosion resistance.It appears that some liposuction machines can go beyond this 95kpa threshold and increase the possibility of device cracks/implosion.The most likely root cause is too much vacuum was applied to the device causing it to crack/implode.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: 19906227
• Report Number: 1651189-2024-07395
• Device Sequence Number: 7136761
• Product Code: QKL
• UDI-Device Identifier: 00810076894621
• UDI-Public: 00810076894621
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2024

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: A47722
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/08/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2024
• Supplement Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 08/05/2024
• Supplement Report FDA Received Date: 04/30/2025
• 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 Age: 54 YR
• Patient Sex: Female