MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) NATRELLE TE SMOOTH 133S-MV-14-T; EXPANDER, SKIN, INFLATABLE

Model Number	133S-MV-14-T
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/14/2022
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
Healthcare professional reported unknown side "the seam around the differing plastic parts of the expander had what appeared to be a hole in it.The fluid squirted out of this hole when the expander was squeezed¿.The device has been explanted.
Event or Problem Description
Healthcare professional reported unknown side "the seam around the differing plastic parts of the expander had what appeared to be a hole in it.The fluid squirted out of this hole when the expander was squeezed¿.The device has been explanted.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified: wear abrasion and an opening on anterior.Leak test and microscopic analysis was performed which identified: a sharp opening on insert to shell bond edge and five striated openings on suture tabs.A dimension measurement in the shell was performed which identified the thickness within specification.Based on the device analysis the final assessment is: an opening with a sharp pattern at the edge of the insert to shell bond area assessed as an unidentified (tear) opening.Five striated openings on suture tabs assessed as surgical damage.
Event or Problem Description
Healthcare professional reported unknown side "the seam around the differing plastic parts of the expander had what appeared to be a hole in it.The fluid squirted out of this hole when the expander was squeezed¿.The device has been explanted.
Additional Manufacturer Narrative
Further investigation summary: 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 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 an 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.Review of all complaints for the period of jul 2020 through jun 2022 related to mfg date has been performed and found one month out of control limit (sep 20) with respect to the reported event.Only the pr#(b)(6) was involved in sep 2020.An additional analysis is not required because only one complaint was involved in this month.However all the events are being captured in capa 348208.

• Brand Name: NATRELLE TE SMOOTH 133S-MV-14-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: 14109036
• Report Number: 9617229-2022-05859
• Device Sequence Number: 20027842
• Product Code: LCJ
• UDI-Device Identifier: 10888628043886
• UDI-Public: 10888628043886
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K182054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/21/2022

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: 01/21/2024
• Device Model Number: 133S-MV-14-T
• Device Catalogue Number: 133S-MV-14-T
• Device Lot Number: 3309725
• 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: 03/15/2022
• Supplement Date Received by Manufacturer: 05/11/2022; 08/30/2022
• Initial Report FDA Received Date: 04/13/2022
• Supplement Report FDA Received Date: 06/07/2022; 09/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2019
• 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: 61 YR
• Patient Sex: Female
• Patient Weight: 64 KG