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

Catalog Number	3501697
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	12/29/2023
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.Since no lot number was provided, no manufacturing record evaluation could be performed.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.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent primary breast augmentation with two unspecified mentor smooth saline breast prostheses.Post-operatively, the patient suffered left breast implant deflation.As a result, the patient underwent breast implant removal surgery on (b)(6) 2024.
Additional Manufacturer Narrative
On march 6, 2024, the mentor failure analysis lab received the device for evaluation.On march 12, 2024, the product investigation was completed.Device investigation summary: the product was returned to mentor for evaluation.Mentor then conducted a visual inspection and microscopic examination of the returned device.Visual analysis of the returned sample revealed that the sal smooth rnd diap 700cc was found to have a tear at the union between the shell and the vulcanization dot.Additionally, an area of missing material was observed on the anterior view, measuring approximately 0.8 x 0.9 cm.Microscopic examination was performed on the edges of the tear and the missing material, and parallel striations were found in an area of the missing material, measuring approximately 0.1 cm.Parallel striations are consistent with markings made by a sharp object perforating the implant shell.The cause in the remaining area of the missing material could not be identified.Parallel striations are consistent with markings made by a sharp object perforating the implant shell.Additionally, the tear did not show striations and the cause of the tear could not be identified.As the authorization form for examination was not received the evaluation was limited to non-destructive testing, therefore, thickness measurement could not be performed.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Although no conclusion could be reach on the cause of the tear, the instructions for use contain the following caution: according with the product insert data sheet, 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 stylet 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 stylet is removed to prevent damage to the valve assembly.A second product was received lot 5908469.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.No corrective and preventive action (capa) is required now.
Additional Manufacturer Narrative
On february 22, 2024, mentor received additional information indicating that the suspect medical device was a 700cc mentor smooth round moderate profile saline (catalog: 3501697 lot: 5908469).A manufacturing record evaluation is in progress.Once completed, a supplemental report will be submitted.

• Brand Name: MENTOR SMOOTH ROUND MODERATE 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: 18736561
• Report Number: 1645337-2024-01982
• Device Sequence Number: 12361206
• Product Code: FWM
• UDI-Device Identifier: 00081317001331
• UDI-Public: 00081317001331
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• 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: Consumer
• 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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/11/2013
• Device Catalogue Number: 3501697
• Device Lot Number: 5908469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/26/2024
• Supplement Date Received by Manufacturer: 02/22/2024; 03/06/2024
• Initial Report FDA Received Date: 02/20/2024
• Supplement Report FDA Received Date: 02/27/2024; 03/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2009
• 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: 35 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White