MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) NATRELLE TE SMOOTH 133S-FX-13-T; EXPANDER, SKIN, INFLATABLE

Model Number	133S-FX-13-T
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances 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: deflation.Device evaluation: analysis of the returned device identified: a thread is observed in one of the tab.Leak test and microscopic analysis was performed which identified: sharp opening.Based on the device analysis the final assessment is: a sharp opening in the insert assessed as an unidentified (tear) opening.
Event or Problem Description
Healthcare professional reported a right side "deflation".The device has been explanted.
Additional Manufacturer Narrative
Further investigation: the review of the documentation associated to the manufacturing process indicates that all devices with work order 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.This event was presented to the capa steering committee and it was decided to open a capa to address the event of openings in insert to shell bond area.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 feb 2019 through jan 2021, it was noted an outlier in oct 2019.However, all the events are being captured in the capa.
Event or Problem Description
Healthcare professional reported a right side "deflation".The device has been explanted.

• Brand Name: NATRELLE TE SMOOTH 133S-FX-13-T
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca; CS
• MDR Report Key: 10730681
• Report Number: 9617229-2020-16870
• Device Sequence Number: 14316961
• Product Code: LCJ
• UDI-Device Identifier: 10888628044036
• UDI-Public: 10888628044036
• Combination Product (Y/N): N
• Initial Reporter State: CA
• PMA/510(K) Number: K182054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2021

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: 01/24/2025
• Device Model Number: 133S-FX-13-T
• Device Catalogue Number: 133S-FX-13-T
• Device Lot Number: 3417853
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2020
• Initial Date Received by Manufacturer: 09/23/2020
• Supplement Date Received by Manufacturer: 03/12/2021
• Initial Report FDA Received Date: 10/23/2020
• Supplement Report FDA Received Date: 04/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention