MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) NATRELLE TE SMOOTH 133S-MV-12-T; EXPANDER, SKIN, INFLATABLE

Model Number	133S-MV-12-T
Medical Device Problem Codes	Deflation Problem (1149); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	12/07/2020
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.
Event or Problem Description
Healthcare professional reported left side deflation.Device has been explanted.
Additional Manufacturer Narrative
Further investigation results: the review of the documentation associated to the manufacturing process indicated that all devices within the 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, a unidentified opening was observed on the border of the insert to shell bond area which was 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 feb/2019 through jan/2021, an outlier was noted in oct/2019, however all the events are being captured in capa 348208.Device evaluation: visual analysis of the returned device identified one curved opening at the edge of the insert to shell bond area.A leak test and microscopic analysis were performed which identified that the curved opening had a sharp pattern on anterior three.A dimensional measurement in the shell was performed which identified the thickness was within specification.The measurement of the opening was 6mm.Based on the device analysis the final assessment was an opening with a sharp pattern at the edge of the insert to shell bond area assessed as an unidentified (tear) opening.
Event or Problem Description
Healthcare professional reported left side deflation.Device has been explanted.

• Brand Name: NATRELLE TE SMOOTH 133S-MV-12-T
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): ALLERGAN (COSTA RICA); 900 parkway global park; zona franca
• MDR Report Key: 11118096
• Report Number: 9617229-2020-21794
• Device Sequence Number: 3595447
• Product Code: LCJ
• UDI-Device Identifier: 10888628043862
• UDI-Public: 10888628043862
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2021

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: 09/26/2024
• Device Model Number: 133S-MV-12-T
• Device Catalogue Number: 133S-MV-12-T
• Device Lot Number: 3381169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2021
• Initial Date Received by Manufacturer: 12/07/2020
• Supplement Date Received by Manufacturer: 02/17/2021
• Initial Report FDA Received Date: 01/05/2021
• Supplement Report FDA Received Date: 03/17/2021
• 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
• Patient Age: 50 YR