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

Catalog Number	SRF-770
Medical Device Problem Codes	Material Rupture (1546); Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported possible rupture.Device has been explanted and replaced.This record relates to the left side.
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.A review of the device history record has been completed.No deviations or non-conformances noted.Reason for reoperation: rupture.
Additional Manufacturer Narrative
Device evaluation: based on the device analysis grid, the assessments of the complaint are: lump/nodule: unable to observe as it is not related to the device.Calcification: unable to observe as it is not related to the device.Silicone migration: unable to observe as it is not related to the device.Inflammation/irritation: unable to observe as it is not related to the device.Additional observations: deformation observed.No further actions are required as no manufacturing issues are observed.
Event or Problem Description
Healthcare professional reported possible rupture.Histology report later showed ¿left breast: intact implant." additionally, histology report showed "chest wall ¿ silicone?,¿ ¿lumped under areola¿, ¿underlying hard nodule (possibly silicone),¿ ¿calcification¿, ¿calcification under nipple/areola¿, ¿calcified¿ and ¿fibrous capsular tissue with abundant implant material and associated giant cell reaction.¿ device has been explanted and replaced.This record relates to the left side.
Additional Manufacturer Narrative
A review of the device history record has been initiated.If any new, changed or corrected information is noted, a supplemental medwatch will be submitted.
Event or Problem Description
Healthcare professional reported possible rupture.Histology report later showed ¿left breast: intact implant." additionally, histology report showed "chest wall ¿ silicone?,¿ ¿lumped under areola¿, ¿underlying hard nodule (possibly silicone),¿ ¿calcification¿, ¿calcification under nipple/areola¿, ¿calcified¿ and ¿fibrous capsular tissue with abundant implant material and associated giant cell reaction.¿ device has been explanted and replaced.This record relates to the left side.
Event or Problem Description
Histology report later showed ¿left breast: intact implant." additionally, histology report showed "chest wall ¿ silicone?,¿ ¿lumped under areola¿, ¿underlying hard nodule (possibly silicone),¿ ¿calcification¿, ¿calcification under nipple/areola¿, ¿calcified¿ and ¿fibrous capsular tissue with abundant implant material and associated giant cell reaction.¿.

• 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: 17259747
• Report Number: 9617229-2023-10967
• Device Sequence Number: 14896427
• Product Code: FTR
• UDI-Device Identifier: 10888628007420
• UDI-Public: 10888628007420
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/26/2024
• 2 Devices were Involved in the Event: 1 2

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: 07/29/2024
• Device Catalogue Number: SRF-770
• Device Lot Number: 3367061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/13/2023
• Supplement Date Received by Manufacturer: 12/20/2023; 02/02/2024; 02/07/2024
• Initial Report FDA Received Date: 07/05/2023
• Supplement Report FDA Received Date: 01/26/2024; 02/05/2024; 02/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2019
• 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 Sex: Female