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

Catalog Number	TRM-345
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/29/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record has been completed.No deviations or non-conformance 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 and "patient¿s concern with the product".This is a known potential adverse event addressed in the product labeling.
Event or Problem Description
Healthcare professional reported "rupture" and "exchange from textured to smooth breast implant due to the patient¿s concern with the product".The device remains implanted.This record is for the left side.
Event or Problem Description
Healthcare professional reported "rupture" and "exchange from textured to smooth breast implant due to the patient¿s concern with the product".The device remains implanted.This record is for the left side.
Additional Manufacturer Narrative
Device evaluation: visual analysis of the returned device identified crease fold, deformation, and cloudiness/bubbles in the gel observed after autoclave disinfection process.Weight measurement of the device identified device weight was within specification.Based on the device analysis the final assessment was no issues found related with the manufacturing process, and no openings/issues related to rupture were observed.
Event or Problem Description
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: 9120764
• Report Number: 9617229-2019-14191
• Device Sequence Number: 2307895
• Product Code: FTR
• UDI-Device Identifier: 10888628002661
• UDI-Public: 10888628002661
• Combination Product (Y/N): N
• Initial Reporter State: NY
• PMA/510(K) Number: P020056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/02/2020

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: 03/13/2021
• Device Catalogue Number: TRM-345
• Device Lot Number: 2900768
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2019
• Initial Date Received by Manufacturer: 08/29/2019
• Supplement Date Received by Manufacturer: 10/09/2019; 12/05/2019
• Initial Report FDA Received Date: 09/25/2019
• Supplement Report FDA Received Date: 11/07/2019; 01/02/2020
• 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: 40 YR