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

Model Number	133S-MV-13-T
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Codes	Abscess (1690); Failure of Implant (1924)
Date of Event	07/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported unknown side tissue expander had "leaked".Device was explanted.
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
Healthcare professional reported unknown side tissue expander had "leaked".Device was explanted.
Additional Manufacturer Narrative
Device evaluation: analysis of the returned device identified: opening curved on anterior.Leak test and microscopic analysis was performed which identified: sharp opening on anterior (insert/shell bond edge).Based on the device analysis the final assessment is: a sharp opening on anterior (insert/shell bond edge) assessed as an unidentified (tear) opening.
Event or Problem Description
Healthcare professional reported left-side tissue expander had leaked when he opened the breast pocket.Later, healthcare professional reported, "abscess @ the left breast".The device has been explanted.
Additional Manufacturer Narrative
Device evaluation: the review of the documentation associated to the manufacturing process indicates that all devices with work order # (b)(6) were released in accordance with abbvie's procedures, and no anomalies were found in the documents or in the personnel training related to the reported event.According to the device analysis performed in the laboratory, it was observed an unidentified (tear) opening on the border of the insert to shell bond area.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 opening 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 (b)(6)2020 through (b)(6) 2022, it was noted an outlier in sep 2020, and it corresponds only to pr#(b)(4).However these events were addressed in capa 348208.The event of "abscess" is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.

• 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: 15117034
• Report Number: 9617229-2022-13228
• Device Sequence Number: 14802346
• Product Code: LCJ
• UDI-Device Identifier: 10888628043879
• UDI-Public: 10888628043879
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K182054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/27/2022

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: 07/12/2025
• Device Model Number: 133S-MV-13-T
• Device Catalogue Number: 133S-MV-13-T
• Device Lot Number: 3456069
• 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: 07/05/2022
• Supplement Date Received by Manufacturer: 07/28/2022; 08/31/2022
• Initial Report FDA Received Date: 07/27/2022
• Supplement Report FDA Received Date: 08/24/2022; 09/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2020
• 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 Age: 55 YR
• Patient Sex: Female