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

Model Number	SRLP-340
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Serious Injury
Event or Problem Description
Healthcare professional reported left side rupture.Device remains 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: rupture.
Event or Problem Description
Device has been explanted.
Additional Manufacturer Narrative
Device evaluation: analysis of the returned device identified: weight to spec, crease fold, wear abrasion, observed split in patch area, it is out of specification per qa 199.04 and white particles in the shell.Air voids in the gel observed after autoclave cycle.The device is no rupture.Base on the device analysis the final assessment is: split in patch area, assessed as a workmanship.
Event or Problem Description
Healthcare professional reported left side rupture.The device has been replaced.
Additional Manufacturer Narrative
Further investigation (fi): the review of the documentation associated to the manufacturing process indicates that all devices with work order #(b)(4) 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 split in patch area, it is out of specification per qa 199.04 which is not related to the reported complaint.A review of the current risk documents was performed and the event of split in patch is a known event, for which manufacturing process controls and inspections are stablished to reduce the incidence of this defect.During the trend review of all split in patch complaints for gel breast implants for the period of may 2020 through apr 2022, was noted an outlier in jun 2020.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 split in patch event, so, no additional actions are deemed required at this time.The issue with split in patch will continue to be monitored and corrective action taken in the future if deemed appropriate.

• 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: 13538664
• Report Number: 9617229-2022-01653
• Device Sequence Number: 5147850
• Product Code: FTR
• UDI-Device Identifier: 10888628006928
• UDI-Public: 10888628006928
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 07/21/2022

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: 06/17/2020
• Device Model Number: SRLP-340
• Device Catalogue Number: SRLP-340
• Device Lot Number: 2776906
• 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: 01/25/2022
• Supplement Date Received by Manufacturer: 05/11/2022; 06/24/2022
• Initial Report FDA Received Date: 02/15/2022
• Supplement Report FDA Received Date: 06/08/2022; 07/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2015
• 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
• Patient Weight: 58 KG