MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) NATRELLE TE SMOOTH 133S-MV-15-T; EXPANDER, SKIN, INFLATABLE

Model Number	133S-MV-15-T
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformance's noted.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: broken device.
Event or Problem Description
Health care professional reported one of the tabs of the tissue expander was free floating in the pocket.Device was not implanted.
Additional Manufacturer Narrative
Device evaluation: based on the device analysis grid, the assessments of the complaint are: broken device: observed, two broken on suture tab (#12 and #4) assessed as surgical damage.A piece of suture tab is missing assessed as inconclusive.Partial delamination of suture tabs assessed as adhesive failure.Additional observations: an opening on anterior side assessed as surgical damage.More than 3 openings on suture tabs (#12, #4, #6 and #10) assessed as surgical damage.Crease flat is observed.A further investigation will be requested to analyze this case.Fi summary: based on the device analysis performed, the event of broken device (¿one of the tabs of the natrelle te smooth 133s-mv-15-t was free floating in the pocket¿) was observed, two broken on suture tabs (#12 and #4) were assessed as surgical damage.Additionally, per the review of the risk documents, the event of suture tabs delamination is a known event for which manufacturing process controls, inspections, and specific control measures are established to reduce the incidence of this defect.This event is categorized as monitor in the residual risk region.Furthermore, a review of all suture tabs delamination complaints for tissue expanders that have been manufactured in the last 2 years (from oct 2020 through sep 2022) was performed and no additional complaints for this event are observed, therefore, it is concluded that this is an isolated event and no additional products/lots are currently involved.Considering that there is not an adverse trend for this type of event, and, no er/ ncr(s) were identified during the investigation associated with this lot and the complaint, no additional actions are deemed required at this time.However, suture tabs delamination events will continue to be monitored and corrective action taken in the future if deemed appropriate.
Event or Problem Description
Health care professional reported one of the tabs of the tissue expander was free floating in the pocket.Device was not implanted.

• Brand Name: NATRELLE TE SMOOTH 133S-MV-15-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: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 15498521
• Report Number: 9617229-2022-16488
• Device Sequence Number: 5242769
• Product Code: LCJ
• UDI-Device Identifier: 10888628043893
• UDI-Public: 10888628043893
• Combination Product (Y/N): N
• Initial Reporter State: FL
• PMA/510(K) Number: K182054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2022

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: 09/02/2025
• Device Model Number: 133S-MV-15-T
• Device Catalogue Number: 133S-MV-15-T
• Device Lot Number: 3465816
• 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: 09/01/2022
• Supplement Date Received by Manufacturer: 10/24/2022
• Initial Report FDA Received Date: 09/28/2022
• Supplement Report FDA Received Date: 11/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2020
• 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: Female