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

Model Number	TRM-310
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Failure of Implant (1924); Swollen Lymph Nodes (2093)
Date of Event	03/04/2020
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: rupture.
Event or Problem Description
Healthcare professional reported a right side rupture.Device has been explanted.
Additional Manufacturer Narrative
Allergan did not submit this mdr within 30 days of becoming aware.Recent stimulated reporting related to 2011068-7/2/19-001-r has increased complaint and mdr volume.Allergan is implementing a plan to address the increased volumes.Device evaluation: visual analysis identified biological tissue, an apparent opening, and labeled as right side.Supplemental visual analysis identified a broken device, could not confirm if device is complete, and could not confirm if it had particles on the shell.The event of "lymphadenopathy" is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.Reason for reoperation: rupture and lymphadenopathy.
Event or Problem Description
Healthcare professional reported right side rupture.Additionally, healthcare professional reported "palpable lymph node in the right axilla, diagnosis: benign reactive lymphadenopathy with interfollicular hyperplasia." device has been explanted.

• Brand Name: INSPIRA TEXTURED 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; CS
• MDR Report Key: 10175448
• Report Number: 9617229-2020-09100
• Device Sequence Number: 14048266
• Product Code: FTR
• UDI-Device Identifier: 10888628008083
• UDI-Public: 10888628008083
• Combination Product (Y/N): N
• Initial Reporter State: OK
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2020

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: 08/29/2021
• Device Model Number: TRM-310
• Device Catalogue Number: TRM-310
• Device Lot Number: 2966963
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/22/2020
• Supplement Date Received by Manufacturer: 07/01/2020
• Initial Report FDA Received Date: 06/19/2020
• Supplement Report FDA Received Date: 10/12/2020
• 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: 39 YR