MAUDE Adverse Event Report: MENTOR TEXAS MENTOR MEMORYSHAPE BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	3341402
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	04/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 43-year-old caucasian female patient underwent revision breast augmentation with 620cc mentor memoryshape breast implant on both sides and experienced breast implant rupture on her right side postoperatively; diagnosed per mri and in the office.The patient has consulted with the healthcare professional.On (b)(6) 2024, mentor became aware that the replacement devices used on december 27, 2023 were catalog number 3505504bc; serial number (b)(6) on the left side, and catalog number 3505504bc; serial number (b)(6) on the right side.Per information received on january 8, 2024, and january 18, 2024, mentor became aware that the right device was intact and experienced bilateral capsular contracture; baker grade iv on right, and grade ii/iii on the left side, and underwent bilateral replacement surgery on december 27, 2023.It was reported that the patient was involved in the car accident.It was also reported that the patient developed a seroma in the right breast.At this time, the results of pathology /cytology report have not been provided.Should additional information become available, this case will be re-assessed and notes will be updated.This medwatch report is for the patient¿s left-sided device.
Additional Manufacturer Narrative
Device evaluation summary: mentor conducted a visual inspection of the returned device.During visual evaluation no apparent damage or visual anomalies were observed on the mentor memoryshape¿ mh 620cc breast implant.Mentor concluded that the capsular contracture in the patient´s breast was the result of the body´s individual physiological response to the implantation of a foreign object in soft tissue.Capsular contracture is a known complication associated with these devices and is referenced in our current product insert data sheet.The american society of plastic surgeons recommends and encourages member surgeons to always submit breast implants, capsule, and effusion to pathology for examination.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Since no malfunction was observed during the investigation, no corrective and preventive action (capa) is required now.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.Reason for device explant and/or reoperation: left capsular contracture; baker grade ii/iii.Mentor is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which mentor has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, mentor, or its employees that the report constitutes an admission that the device, mentor, or its employees caused or contributed to the potential event described in this report.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYSHAPE BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer (Section G): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer Contact: kate karberg ; 3041 skyway circle north; irving, TX 75038 ; 3035526892
• MDR Report Key: 18602990
• Report Number: 1645337-2024-01004
• Device Sequence Number: 9127925
• Product Code: FTR
• UDI-Device Identifier: 00081317005247
• UDI-Public: 00081317005247
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P060028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: 02/27/2020
• Device Catalogue Number: 3341402
• Device Lot Number: 6906867
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/08/2024
• Initial Report FDA Received Date: 01/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2015
• 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 Age: 43 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White