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

Model Number	VIALITY-1400
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sientra complaint #: (b)(4).Patient age defaulted to "99" as patient information was not provided.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
After using liposuction to collect fat into viality device, the surgeon pulled the drawer to expose fat to sponge and only a scant amount of fluid absorbed into the sponge.The excess fluid would not suction out of the viality machine either.The surgeon then opened a second device and the same exact problem occurred.Surgeon then had to dry fat out on lap sponges in order to dry fat.This surgeon has used viality multiple times and has never experienced this before, patient did not have fibrous fat.This record captures the second viality unit used in the procedure.

• 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.; suite 650; franklin WI 53132
• Manufacturer Contact: denise dajles ; 8055628401
• MDR Report Key: 18503492
• Report Number: 1651189-2024-06208
• Device Sequence Number: 7901775
• Product Code: QKL
• UDI-Device Identifier: 00810076894621
• UDI-Public: 00810076894621
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/12/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 12/18/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2023
• Initial Report FDA Received Date: 01/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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