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

Model Number	3541907MC
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	04/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 48-year-old caucasian female patient underwent a breast surgery with a 190cc mentor memorygel breast implant and experienced a rupture on the left side post-operatively, which was diagnosed with a mammogram.As a result, the patient underwent explantation on (b)(6) 2022.
Additional Manufacturer Narrative
Since the device has not been returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors can be made.As such, the investigation will be closed.If the complaint device is received in the future, the investigation will be reopened and conducted as appropriate.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: rupture.Explantation date: (b)(6) 2022.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On november 07, 2022, the mentor failure analysis lab has received the device for evaluation.On november 11, 2022, the evaluation for the device was completed.Device evaluation summary: visual analysis of the returned sample revealed that the sx mod classic gel, 190cc breast implant had a tear on the posterior view, measuring approximately 2.1 cm.Additionally an area of siltex cracking was noted on the edge of the tear.The evaluation determined that the cause of the rupture is consistent with normal wear.Siltex cracking is defined as a material separation occurring in the siltex layer and can eventually progress through the shell of siltex devices.Siltex cracking is ultimately a result of high stresses.It should be noted that 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 will be conducted through complaint trending as part of post market surveillance.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On july 20, 2022, mentor received additional information regarding the date of event.The date of event has been updated to (b)(6) 2022 in section b3 of this report.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: 15008452
• Report Number: 1645337-2022-08236
• Device Sequence Number: 15158372
• Product Code: FTR
• UDI-Device Identifier: 00081317004349
• UDI-Public: 00081317004349
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2018
• Device Model Number: 3541907MC
• Device Catalogue Number: 3541907MC
• Device Lot Number: 6786091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/21/2022
• Supplement Date Received by Manufacturer: 07/20/2022; 11/07/2022
• Initial Report FDA Received Date: 07/13/2022
• Supplement Report FDA Received Date: 08/08/2022; 11/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2013
• 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: 48 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White