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

Catalog Number	3341209G
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cyst(s) (1800)
Date of Event	11/07/2023
Type of Reportable Event	Serious Injury
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 is in progress.  once completed, a supplemental report will be submitted.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.  if certain information is unknown, not available or does not apply, the section/field of the form is left blank.Reason for device explant and/or reoperation: breast cyst.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent a primary breast augmentation surgery with 350cc mentor memoryshape breast implants.Post-operatively, the patient experienced a rupture of her left prosthesis, which was confirmed via ultrasound and complicated by granuloma formation in the left axilla.Small cysts were observed in the upper outer quadrant of the right breast and the retro areolar region of the left breast.It was also reported that the patient experienced implant site calcification of the left breast.As a result, the patient underwent bilateral removal and replacement with 355cc mentor memorygel boost breast implants on (b)(6) 2024.This report is for the right implant.Refer to manufacturing report number 1645337-2024-04361 for the contralateral event.
Additional Manufacturer Narrative
On april 24, 2024, mentor received the device for evaluation.On april 30, 2024, mentor completed a visual inspection and leak testing of the returned device.Device evaluation summary: visual analysis of the returned sample revealed that the breast implant was found to have some bubbles within the gel.Leak testing was performed, in accordance with mentor procedures, and no areas of gel exposure were detected during the analysis.Bubbles in the gel can be originated with changes in pressure and temperature which can affect volume.The shell wall is permeable to air, therefore trapped air can form bubbles with changes in pressure or temperature.When left by themselves with no changes in temperature or pressure, bubbles usually dissipate over time, unless trapped by cured gel.A breast cyst is a fluid-filled sac within the breast.One breast can have one or more breast cysts.They are often described as round or oval lumps with distinct edges.Breast cysts are usually and typically do not require treatment, but they can be drained using fine needle aspiration if the cyst is large or uncomfortable.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On may 03, 2024, mentor became aware that information was inadvertently omitted from the previous supplemental report.Manufacturer¿s reference number: (b)(4) in the previous report, h10 additional manufacturer narrative should have included the following information: 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.

• 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: 19083837
• Report Number: 1645337-2024-04362
• Device Sequence Number: 8283400
• Product Code: FTR
• UDI-Device Identifier: 00081317005070
• UDI-Public: 00081317005070
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P060028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2024
• 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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/28/2012
• Device Catalogue Number: 3341209G
• Device Lot Number: 5767383
• 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: 04/02/2024
• Supplement Date Received by Manufacturer: 04/24/2024; 05/03/2024
• Initial Report FDA Received Date: 04/10/2024
• Supplement Report FDA Received Date: 05/03/2024; 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2007
• 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: Hispanic