MAUDE Adverse Event Report: INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	TSF-345
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Granuloma (1876); Swollen Lymph Nodes/Glands (4432)
Date of Event	01/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device visual evaluation: visual analysis of the photographs identified: opening.Device analysis performed through photographs, due to the impossibility to perform microscopic analysis it is not possible to determine the most likely failure mode the event of granuloma is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.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 left side rupture, free silicone, and small foreign body granulomas.The device has been explanted.
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformances noted.
Event or Problem Description
Healthcare professional reported left side rupture, free silicone, and small foreign body granulomas.The device has been explanted.
Additional Manufacturer Narrative
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: ¿firm mobile lump¿ was confirmed to be ¿a silicone replaced lymph node¿.
Event or Problem Description
Treatment - device explant along with capsulectomy and mastopexy.Healthcare professional reported "histopathology specimen of left capsule show fibrous capsules containing globules of extruded silicone, some with adjacent small foreign body granulomas".¿firm mobile lump¿ was confirmed to be ¿a silicone replaced lymph node¿.

• Brand Name: INSPIRA TEXTURED SILICONE GEL FILLED BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• MDR Report Key: 11658361
• Report Number: 9617229-2021-06117
• Device Sequence Number: 3617370
• Product Code: FTR
• UDI-Device Identifier: 10888628034136
• UDI-Public: 10888628034136
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/29/2021

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: 11/09/2015
• Device Model Number: TSF-345
• Device Catalogue Number: N-TSF345
• Device Lot Number: 2040210
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/16/2021
• Supplement Date Received by Manufacturer: 09/01/2021; 10/07/2021
• Initial Report FDA Received Date: 04/13/2021
• Supplement Report FDA Received Date: 10/01/2021; 10/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2010
• 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: 60 YR