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	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/06/2021
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.
Event or Problem Description
Company representative reported unknown side deflation of a tissue expander.It is not known if the device has been explanted or status of replacement.
Event or Problem Description
Device has been explanted.
Additional Manufacturer Narrative
A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified, a curved opening on the edge of the insert to shell bond area in the anterior 4 location.A microscopic analysis and leak test were performed, which identified that the curved opening has a sharp pattern.A dimension measurement in the shell was performed, which identified the thickness within specification.The measurement of the opening is 1.0 cm.Based on the device analysis, the final assessment is: an opening with a sharp pattern at the edge of the insert to shell bond are assessed, as an unidentified tear opening.
Event or Problem Description
Company representative reported, unknown side deflation of a tissue expander.Device has been explanted.
Additional Manufacturer Narrative
Summary: the review of the documentation associated to the manufacturing process indicates that all devices with work order # (b)(4) 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 capa 348208 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 oct 2019 through sep 2021, it was noted an outlier in oct 2019.However all the events are being captured in capa 348208.
Event or Problem Description
Healthcare professional confirmed right side deflation of a tissue expander.Device has been explanted.

• 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: chris sprague ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479375615
• MDR Report Key: 11948027
• Report Number: 9617229-2021-07319
• Device Sequence Number: 4229345
• Product Code: LCJ
• UDI-Device Identifier: 10888628043893
• UDI-Public: 10888628043893
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K182054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/14/2022

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: 11/13/2024
• Device Model Number: 133S-MV-15-T
• Device Catalogue Number: 133S-MV-15-T
• Device Lot Number: 3396965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2021
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 05/11/2021
• Supplement Date Received by Manufacturer: 05/11/2021; 08/06/2021; 10/11/2021
• Initial Report FDA Received Date: 06/07/2021
• Supplement Report FDA Received Date: 06/30/2021; 09/03/2021; 06/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2019
• 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 Age: 44 YR
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Ethnicity: Hispanic
• Patient Race: White