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

Model Number	3501490
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	05/31/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a 68-year-old caucasian female patient underwent a breast augmentation revision surgery with implantation of a 575cc mentor smooth round spectrum saline breast implant prosthesis.Post-operatively, the patient was diagnosed with a deflated right 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
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.  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: the patient has not undergone explantation or reoperation at this time.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On june 28, 2023, mentor was notified that the patient will have the removal surgery in (b)(6), 2023.However, an exact date was not provided.If more information is received, a follow-up report will be submitted.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 date of explantation: (b)(6) 2023.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On december 06, 2023, mentor was notified that the patient's explantation date was rescheduled for (b)(6) 2024.Date of explantation: (b)(6) 2024.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On january 19, 2024, 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.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On march 06, 2024, mentor completed an evaluation on the returned device.The product was returned to mentor for evaluation with approximately 27 cm of tubing attached to the implant, the connector and injection dome were returned.Mentor conducted visual inspection leak testing, and microscopic examination of the device.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the breast implant.The tube was examined, and it was noted that the plug valve was separate from the tube inside the implant and was not sited on the valve, therefore the valve and implant were still in an open position allowing the solution to flow out of the device.Leak testing was performed, in accordance with mentor procedures, and it identified two tears on the anterior view (tear a and tear b), both measuring approximately less than 0.1 cm.Then the tubing was removed from the valve and the plug valve was manually seated, and the product worked as expected.An additional leak test was performed, and no additional leak sites were detected.Microscopic examination was performed on the edges of both tears (tear a and tear b) and the tubing, and parallel striations were found in the whole area of the tears.Parallel striations are consistent with markings made by a sharp object perforating the implant shell.However, the cause of the separation between the tubing and the plug valve could not be determined.The product insert data sheet states that when removing the injection dome and fill tube, the tube needs to be grasped beyond the connector and the tube needs to be removed before taking the injection dome out.Do not pull on the connector while removing the tube as it may disconnect, and subsequent deflation could occur.Use slow and steady traction to remove the fill tube and thus prevent damage to the prosthesis or its self-sealing valve.Continue to pull firmly on the fill tube until the entire length of the tube is withdrawn, which will be evidenced by a notch in the end of the tube.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR SMOOTH ROUND SPECTRUM
• 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: 17199001
• Report Number: 1645337-2023-07519
• Device Sequence Number: 15138837
• Product Code: FWM
• UDI-Device Identifier: 00081317002048
• UDI-Public: 00081317002048
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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,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: 09/09/2022
• Device Model Number: 3501490
• Device Catalogue Number: 3501490
• Device Lot Number: 7615717
• 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: 06/05/2023
• Supplement Date Received by Manufacturer: 06/28/2023; 12/06/2023; 01/19/2024; 03/06/2024
• Initial Report FDA Received Date: 06/26/2023
• Supplement Report FDA Received Date: 07/12/2023; 12/28/2023; 02/15/2024; 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2018
• 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: Other; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White