MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) NATRELLE TE SMOOTH 133S-MX-16-T; EXPANDER, SKIN, INFLATABLE

Model Number	133S-MX-16-T
Medical Device Problem Codes	Deflation Problem (1149); Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930); Seroma (2069)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.Reason for reoperation: ¿deflation, 4 holes in the lower pole¿.
Event or Problem Description
Healthcare professional reported unknown side tissue expander with "4 holes in the lower pole." device has been explanted.
Event or Problem Description
Healthcare professional reported infection and seroma of left breast.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.Device evaluation:analysis of the returned device identified: opening linear on anterior.Leak test and microscopic analysis was performed which identified: sharp opening on anterior.A dimension measurement in the shell was performed which identify the thickness within specification based on the device analysis the final assessment is:a sharp opening on anterior assessed as an unidentified (tear) opening.Additional, changed, and/or corrected data: b.5, d.1 , d.4, d.6b, d9, g1.G.4 , h.3 , h.4 , h6 the event of "seroma" is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.Reason for reoperation: infection and seroma fi:the review of the documentation associated to the manufacturing process indicates that all devices with work order # 3413910 were released in accordance with allergan procedures, and no anomalies were found in the documents related to the reported event.According to the device analysis performed in the laboratory, it was observed and unidentified opening on the border of the insert to shell bond area which is related to the reported complaint.According to the current risk documents the event of leakage (or opening) in the insert/shell assembly process is a known failure mode and manufacturing process controls and inspections are stablished to reduce the incidence of this failure mode.During the trend review of all complaints with an opening on border of insert to shell bond area for tissue expander for the period of sep 2019 through aug 2021, it was noted an outlier in oct 2019.

• Brand Name: NATRELLE TE SMOOTH 133S-MX-16-T
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• Manufacturer (Section G): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• Manufacturer Contact: chris sprague ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479375615
• MDR Report Key: 11457309
• Report Number: 9617229-2021-02856
• Device Sequence Number: 17043368
• Product Code: LCJ
• UDI-Device Identifier: 10888628044227
• UDI-Public: 10888628044227
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K182054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/14/2025
• Device Model Number: 133S-MX-16-T
• Device Catalogue Number: 133S-MX-16-T
• Device Lot Number: 3413910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2021
• Supplement Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 03/10/2021
• Supplement Report FDA Received Date: 05/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2020
• 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