MAUDE Adverse Event Report: MENTOR TEXAS MENTOR SMOOTH ROUND HIGH PROFILE; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Catalog Number	3503210
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	05/23/2023
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: deflation date of explantation: (b)(6) 2023.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a 44-year-old caucasian female patient underwent a primary breast augmentation surgery with implantation of a 210cc mentor smooth round high profile saline breast implant prosthesis.Post-operatively, the patient was diagnosed with a deflated left breast implant during an in-office visit with a medical professional.Mammogram imaging was also conducted.As a result, the patient is scheduled for removal on (b)(6) 2023.
Additional Manufacturer Narrative
On august 21, 2023, mentor completed a manufacturing record evaluation (mre) for lot 5983296.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.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On september 26, 2023, mentor was notified that explantation surgery was rescheduled.The patient underwent bilateral breast implant removal and replacement on (b)(6) 2023.On october 12, 2023, mentor became aware that the patient underwent bilateral replacement with 210cc mentor smooth round high profile saline breast implants.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On october 17, 2023, the mentor analysis lab received the suspect medical device for evaluation.On october 24, 2023, mentor completed an evaluation on the returned device.Mentor conducted a visual inspection, leak testing and microscopic examination of the device.During visual analysis of the returned sample no apparent damage or visual anomalies were observed.Leak testing was performed in accordance with mentor's procedures.Findings revealed a leak from the valve.A microscopic examination was performed, and the cause of the leakage could not be determined.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR SMOOTH ROUND HIGH PROFILE
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• 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: 17572015
• Report Number: 1645337-2023-09222
• Device Sequence Number: 8765302
• Product Code: FWM
• UDI-Device Identifier: 00081317001584
• UDI-Public: 00081317001584
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,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: 04/30/2014
• Device Catalogue Number: 3503210
• Device Lot Number: 5983296
• 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: 07/19/2023
• Supplement Date Received by Manufacturer: 08/21/2023; 09/26/2023; 10/17/2023
• Initial Report FDA Received Date: 08/18/2023
• Supplement Report FDA Received Date: 08/28/2023; 10/12/2023; 10/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2010
• 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: 44 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White