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

Model Number	3542711
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	10/01/2021
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.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 (b)(6) year-old caucasian female patient underwent a breast augmentation primary with a saline mentor siltex contour profile high 275cc breast implant and experienced deflation on the right side post-operatively.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.
Additional Manufacturer Narrative
On jan 3 2022, additional information was received indicating the explantation surgery has been rescheduled to (b)(6) 2022.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Device evaluation summary: the product was returned to mentor for evaluation.Mentor conducted a visual inspection and microscopic examination of the returned device.Visual analysis of the returned sample revealed that the sal silt contr diap pkg 275cc was found to have a tear on the anterior view near the valve system.A microscopic examination was performed, and the cause of the tear could not be identified.Although no conclusion could be reached on the cause of the reported event, the instructions for use contain the following caution: according to 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 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.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On nov 3 2021, additional information was received indicating the patient is scheduled for explantation on (b)(6) 2021.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).
Additional Manufacturer Narrative
On feb 17 2022, additional information was received indicating the date of implantation was (b)(6) 1998.On mar 8 2022, the mentor failure analysis lab 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).

• Brand Name: MENTOR SILTEX CONTOUR PROFILE HIGH
• 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: gabriel alfageme ; 3041 skyway circle north; irving, TX 75038 ; 9497898687
• MDR Report Key: 12738298
• Report Number: 1645337-2021-12166
• Device Sequence Number: 4550795
• Product Code: FWM
• UDI-Device Identifier: 00081317001904
• UDI-Public: 00081317001904
• 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: 1998
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 10/15/2021

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: 09/30/2005
• Device Model Number: 3542711
• Device Catalogue Number: 3542711
• Device Lot Number: 164995
• 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: 10/15/2021
• Supplement Date Received by Manufacturer: 11/03/2021; 01/03/2022; 02/17/2022; 04/06/2022
• Initial Report FDA Received Date: 11/02/2021
• Supplement Report FDA Received Date: 11/29/2021; 01/24/2022; 03/16/2022; 04/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/1997
• 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: 50 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White