MAUDE Adverse Event Report: ALLERGAN (COSTA RICA) INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	SSF-265
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported "defective packaging for an implant" and "the seal containing the implant inside the box would not come off and the surgeon didn¿t feel comfortable using it." da lab received the device and reported the event of "thermoform delamination." device was not implanted.
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: device not implanted.Device evaluation: based on the device analysis grid, the assessments of the complaint are: visual analysis of the photographs identified: tyvek or thermoform sticking: observed delamination of thermoform.No additional observations are performed.A further investigation is requested for the event of thermoform delamination.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: d4, h6 further investigation: the review of the documentation associated to the manufacturing process indicates that all devices with lot number 3641754 were released in accordance with abbvie¿s procedures and were no defects/problems/issues found in the documents or in the personnel training related to the reported event.Additionally, no er/ ncr(s) were identified during the investigation associated with this lot and the complaint.According to the device analysis performed in the laboratory, a delamination of the lid was observed, and this further investigation was requested to review the event.A review of the current risk documents afmea-bi family rev.5.0 and dfmea-bi pkg and lblg rev.4.0 was performed, and the event of difficult to open packaging (lid delamination) is a known event, for which current process controls and inspections are established to reduce the incidence of this defect.During the trend review of all lid delamination complaints for gel breast implants for the period of (b)(6) 2021 through (b)(6) 2023, was noted 1 outlier in (b)(6) 2023.The additional analysis performed shows all that results met the acceptance criteria and no issues, deviations or non-conformances were found which could be associated to the lid delamination event, so, no additional actions are deemed required at this time.The issue with lid delamination will continue to be monitored and corrective action taken in the future if deemed appropriate.
Event or Problem Description
Healthcare professional reported "defective packaging for an implant" and "the seal containing the implant inside the box would not come off and the surgeon didn¿t feel comfortable using it." da lab received the device and reported the event of "thermoform delamination." device was not implanted.

• Brand Name: INSPIRA SMOOTH SILICONE GEL FILLED BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• 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: 18098857
• Report Number: 9617229-2023-19321
• Device Sequence Number: 7710294
• Product Code: FTR
• UDI-Device Identifier: 10888628033092
• UDI-Public: 10888628033092
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2023

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: SSF-265
• Device Lot Number: 3641754
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/17/2023
• Supplement Date Received by Manufacturer: 11/30/2023
• Initial Report FDA Received Date: 11/09/2023
• Supplement Report FDA Received Date: 12/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2022
• 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: Other
• Patient Sex: Female