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

Model Number	3546001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Local Reaction (2035); Deformity/ Disfigurement (2360); Breast Mass (2439); Swollen Lymph Nodes/Glands (4432)
Date of Event	07/26/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a (b)(6)-year-old african american female who had 600cc mentor memorygel breast implants placed experienced bilateral impaired wound healing and left sided rupture post procedure.In (b)(6) of 2022 the patient underwent mastopexy and breast augmentation without replacement.The left sided device was replaced with a new 600cc mentor memorygel breast implant due to rupture in (b)(6) 2020.Bilateral ptosis, bilateral local reaction, bilateral lymphadenopathy, right sided capsular contracture, right sided rupture, and left sided breast mass was noted with the new set of breast implants.The right sided rupture and bilateral local reaction was detected through magnetic resonance imaging.The presence of peri implant effusion was noted.The lymphadenopathy was noted through ultrasound which detected prominent lymph nodes.The ultrasound also detected a benign breast mass on the left side.As a result, replacement with 525cc mentor memorygel breast implants was performed on (b)(6) 2022.The right sided implanted was reported initially under 1645337-2021-12569 on (b)(6) 2021.The left sided device explanted on (b)(6) 2020, was reported under 1645337-2021-12568 on (b)(6) 2021.On april 14, 2022, mentor received additional information and initial awareness of issues with the left sided device implanted on (b)(6) 2020.This report relates to the left sided device implanted on (b)(6) 2020.
Additional Manufacturer Narrative
The mentor failure analysis lab has received the device for evaluation.The analysis has begun but is not complete at this time.When the investigational analysis has been completed, a supplemental report will be submitted.A manufacturing record evaluation (mre) was performed, and no anomalies were found related to this complaint.In addition, the mre verifies that the device was manufactured in accordance with documented specification and procedures.Reason for device explant and/or reoperation: ptosis, lymphadenopathy, local reaction, breast mass.If certain information is unknown, not available or does not apply, the section/field of the form is left blank.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
The investigation of the returned device was completed by the failure analysis lab on july 19, 2022.Device evaluation summary: the product was returned to mentor for evaluation.Mentor conducted a visual inspection and leak testing of the returned device.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the breast implant.Leak testing was performed in accordance with mentor procedures, and no leak sites were detected during the analysis.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYGEL 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: michelleann garcia ; 3041 skyway circle north; irving, TX 75038 ; 646591-7981
• MDR Report Key: 14319289
• Report Number: 1645337-2022-05238
• Device Sequence Number: 14751929
• Product Code: FTR
• UDI-Device Identifier: 00081317000945
• UDI-Public: 00081317000945
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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: 01/09/2021
• Device Model Number: 3546001
• Device Catalogue Number: 3546001
• Device Lot Number: 7280443
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/14/2022
• Supplement Date Received by Manufacturer: 07/19/2022
• Initial Report FDA Received Date: 05/07/2022
• Supplement Report FDA Received Date: 08/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2016
• 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: 42 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American