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

Catalog Number	133S-MV-13-T
Medical Device Problem Codes	Fluid/Blood Leak (1250); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/28/2023
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: ¿leak at junction of shell to expander port¿, of ¿as no replacement available - used cyanoacrylate glue and then re expanded the expander to 270cc and it seemed to hold¿.
Event or Problem Description
Healthcare professional reported a right side "leak at the junction of the shell with the port" and "as no replacement available - used cyanoacrylate glue".Device remains implanted.
Additional Manufacturer Narrative
Device evaluation: based on the device analysis grid, the assessments of the complaint are: ¿ deflation-port leak and/or damage: observed opening on insert/shell bond edge assesses unidentified (tear) opening.Shell thickness within specification.¿ use error: unable to observe since it is not related to the device.Additional observations: ¿ missing pieces of suture tabs assessed as inconclusive.¿ observed broken suture tabs assessed surgical damage.
Event or Problem Description
Healthcare professional reported a right side "leak at the junction of the shell with the port" and "as no replacement available - used cyanoacrylate glue".Healthcare professional later also reported "hole, non-specific and at junction of expander port meets expander - derma bond on it.Leak at 4:00 position - slowly deflating did not hold volume".Device has been explanted.
Event or Problem Description
Healthcare professional later, also reported, "hole non-specific.And at junction of expander port meets expander, derma bond on it.Leak at 4:00 position.Slowly, deflating did not hold volume".Device has been explanted.

• Brand Name: NATRELLE TE SMOOTH 133S-MV-13-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: 17787996
• Report Number: 9617229-2023-15526
• Device Sequence Number: 15016010
• Product Code: LCJ
• UDI-Device Identifier: 10888628043879
• UDI-Public: 10888628043879
• 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 Implanted Year: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/19/2023

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: 09/11/2026
• Device Catalogue Number: 133S-MV-13-T
• Device Lot Number: 3556479
• 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: 08/29/2023
• Supplement Date Received by Manufacturer: 10/11/2023; 12/05/2023
• Initial Report FDA Received Date: 09/21/2023
• Supplement Report FDA Received Date: 10/31/2023; 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2021
• 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: 56 YR
• Patient Sex: Female
• Patient Weight: 61 KG