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

Model Number	3502700
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	01/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the time of this report, mentor has received no information regarding explantation or an expected explantation date.  it is unknown at this time if the device will be made available for return.  as a result, 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.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.  reason for device explant and/or reoperation: the patient has not undergone explantation or reoperation at this time.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a 43-year-old caucasian female patient underwent a primary breast augmentation surgery with implantation of a 700cc mentor smooth round moderate plus profile saline breast implant prosthesis.Post-operatively, the patient was diagnosed with a deflated left breast implant during a physical exam with a medical professional.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.Follow-ups are being conducted.If more information becomes available, mentor will submit a supplemental report accordingly.
Additional Manufacturer Narrative
On august 24, 2023, the mentor analysis lab received the suspect medical device for evaluation.On august 25, 2023, mentor completed an evaluation on the returned device.Mentor then 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, according with mentor procedure, and it revealed two tears (a and b), both measuring approximately less than 0.1cm on the posterior view.Microscopic examination was performed and the cause of the deflation could not be identified.As the authorization form for examination was not received the product evaluation lab couldn´t identify a conclusion due to the specific nature of this deflation.The evaluation was limited to non-destructive testing.Although no conclusion could be reached on the cause of the reported event, the instructions for use contain the following caution: causes of deflation of saline implants include but are not limited to the following events: crease fold failure, intraoperative or postoperative trauma, excessive stresses or manipulations as may occur during normal, daily routines including customary and purposeful trauma such as that which can occur during vigorous exercise, athletics, etc.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On september 21, 2023, mentor completed a reevaluation of the device as the authorization form for examination was received.Mentor conducted a thickness measurement of the returned device.Microscopic examination was performed and the cause of both tears could not be identified.Therefore a thickness measurement was conducted on the shell at both tears, and the thickness was within manufacturing specifications.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On july 27, 2023, mentor was notified that the patient was scheduled for bilateral removal and replacement on (b)(6) 2023.On august 11, 2023, mentor became aware that the patient underwent bilateral replacement with 700cc mentor smooth round moderate plus profile saline breast implants.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.Reason for device explant and/or reoperation: deflation.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR SMOOTH ROUND MODERATE PLUS 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: 16854202
• Report Number: 1645337-2023-05088
• Device Sequence Number: 20724465
• Product Code: FWM
• UDI-Device Identifier: 00081317001515
• UDI-Public: 00081317001515
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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: 10/14/2019
• Device Model Number: 3502700
• Device Catalogue Number: 3502700
• Device Lot Number: 6984751
• 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: 04/11/2023
• Supplement Date Received by Manufacturer: 07/27/2023; 08/24/2023; 09/21/2023
• Initial Report FDA Received Date: 05/02/2023
• Supplement Report FDA Received Date: 08/11/2023; 08/28/2023; 09/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2015
• 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; Other
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White