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

Model Number	3503230
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	05/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section d 6b.Explantation date: june 29, 2023 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: material rupture 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.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a 50-year old asian female patient underwent breast augmentation revision with a 230cc mentor smooth round high profile saline breast prosthesis on the right breast.Post-operatively, the patient was diagnosed with spontaneous right breast implant deflation.As a result, the patient has been scheduled for breast implant removal surgery on (b)(6) 2023.The date of implantation provided was after the expiration of the device.Follow-up is in progress and a supplemental report will be submitted when clarifying information is made available.
Additional Manufacturer Narrative
On july 5, 2023, mentor received additional information indicating that the patient's implants were replaced with the following devices: (right) 325cc mentor memorygel breast implant catalog: 3503254bc lot: 9802002 sn: (b)(6) and (left) 325cc mentor memorygel breast implant catalog: 3503254bc lot: 9802002 sn: (b)(6).
Additional Manufacturer Narrative
On july 10, 2023, mentor received additional information indicating that the correct date of implantation was on (b)(6) 2005.
Additional Manufacturer Narrative
On july 18, 2023, the mentor failure analysis lab received the device for evaluation.On july 19, 2023, the product investigation was completed.Device investigation summary: the product was returned to mentor for evaluation.Mentor then conducted a visual inspection, leak testing, microscopic examination, and thickness measurement of the returned device.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the sm hps dv 230cc implant.Leak testing was performed, in accordance with mentor procedures, and a tear was noted at a junction of the valve system.A microscopic examination was performed and the cause of the deflation could not be identified.Therefore a thickness measurement was conducted on the shell at the tear, and the thickness was within manufacturing specifications.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Although no conclusion could be reached on the cause of the reported event, the instructions for use contain the following caution: the valve system can be damaged by improper use of the fill-tube stylet.Care should be taken that the stylet enters the valve smoothly.Use the thumb and forefinger to stabilize/support the valve seat and gently push the stylet tip into the valve opening.Overstressing the valve material may result in punctures or tears and subsequent deflation may occur.Use only the fill tube style provided with this product.Take care not to puncture the diaphragm valve or the shell with the stylet tip.Care must also be taken when the fill tube style is removed to prevent damage to the valve assembly.A second product was received (lot-258226).No adverse events were reported for this concomitant (contralateral) device, therefore no further analysis is required.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Capa activity was not required.

• 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: 17120165
• Report Number: 1645337-2023-06994
• Device Sequence Number: 6612173
• Product Code: FWM
• UDI-Device Identifier: 00081317001591
• UDI-Public: 00081317001591
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• 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: 03/10/2009
• Device Model Number: 3503230
• Device Catalogue Number: 3503230
• Device Lot Number: 5591476
• 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: 05/22/2023
• Supplement Date Received by Manufacturer: 07/05/2023; 07/10/2023; 07/18/2023
• Initial Report FDA Received Date: 06/13/2023
• Supplement Report FDA Received Date: 07/05/2023; 07/17/2023; 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2005
• 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: 50 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian