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

Catalog Number	TCF-335
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	08/29/2018
Type of Reportable Event	Serious Injury
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.Information contained in this report was previously submitted through psr on 01/22/2019.A review of the device history record has been completed.No deviations or non-conformances noted.The event of capsular contracture is a physiological complication and analysis of the device generally does not assist allergan in determining a probable cause for this event.Device evaluation:visual analysis of the returned device identified: curved opening, yellow encapsulation, flat creases, around 0-25% of the shell is missing and a weight test of the explanted material was verified and it was overweight.Microscopic analysis of the return device identified: nicks with striations assessed as surgical tool scratch like, broken shell with striated edge on anterior side assessed as surgical damage and two curved striated opening on anterior side assessed as surgical damage, besides, observed a wear with striated pattern on anterior side.Based on the device analysis the final assessment is: broken shell with striated edge assessed as surgical damage.Missing shell that is assessed as inconclusive.Curved striated openings assessed as surgical damage.Visual analysis and microscopic analysis reported: flat creases and nicks with striations assessed as surgical tool scratch like.Reason for reoperation was due to.This is a known potential adverse event addressed in the product labeling.
Event or Problem Description
Healthcare professional reported a right side capsular contracture, baker grade iii and "exchange from textured to smooth breast implants due to the patient¿s concern with the product." device has been explanted.

• Brand Name: INSPIRA TEXTURE COHESIVE 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: 9497142
• Report Number: 9617229-2019-16655
• Device Sequence Number: 11148588
• Product Code: FTR
• UDI-Device Identifier: 10888628031081
• UDI-Public: 10888628031081
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/19/2019

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: 10/21/2021
• Device Catalogue Number: TCF-335
• Device Lot Number: 2991086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2019
• Initial Report FDA Received Date: 12/19/2019
• 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: 35 YR