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	11/29/2021
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.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: deflation.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a female patient underwent a revision breast augmentation with a 275cc mentor siltex contour profile high prosthesis and experienced right-sided deflation postoperatively.The diagnosis was confirmed based on the patient¿s symptoms and unspecified imaging.As a result, the patient underwent removal and replacement with two mentor breast implants (catalog #: 334-1206, left serial #: (b)(4), right serial #: (b)(4)) on (b)(6) 2021.After the revision surgery, the patient was fully recovered.
Additional Manufacturer Narrative
On (b)(6) 2021, the suspected medical device was returned for evaluation.On (b)(6) 2022, the investigation on the suspected medical device was completed.Investigation summary: mentor conducted a visual inspection and leak testing of the returned device.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the breast implant.Leak testing was performed, according to the mentor procedure, and it revealed a tear on the posterior view within the siltex cracking, measuring approximately 0.3 cm.The evaluation determined that the cause of the deflation is consistent with normal wear.Siltex cracking is defined as a material separation occurring in the siltex layer and can eventually progress through the shell of siltex devices.Siltex cracking is ultimately a result of high stresses.As part of mentor¿s quality process all devices are manufactured, inspected, and released to approved specifications.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: 13047501
• Report Number: 1645337-2021-14074
• Device Sequence Number: 13891137
• Product Code: FWM
• UDI-Device Identifier: 00081317001904
• UDI-Public: 00081317001904
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,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: 12/31/2014
• Device Model Number: 3542711
• Device Catalogue Number: 3542711
• Device Lot Number: 6428738
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/30/2021
• Supplement Date Received by Manufacturer: 12/30/2021
• Initial Report FDA Received Date: 12/20/2021
• Supplement Report FDA Received Date: 01/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2010
• 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 Sex: Female
• Patient Weight: 69 KG