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

Model Number	3542512
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Seroma (2069); Swollen Lymph Nodes/Glands (4432); Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA ALCL) (4549)
Date of Event	09/15/2020
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: unknown.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported via french health authority ansm that a (b)(6) year-old female patient underwent a breast reconstruction procedure with a 350cc mentor siltex contour profile spectrum saline breast prosthesis on (b)(6) 1997.On (b)(6) 2016, the patient underwent a total capsulectomy and replacement with an unspecified sebbin group implant (catalog # lsa sl 280, lot # fh00436), which is still implanted at the time of this report.The explanted mentor device was found intact and it is currently unknown why the patient had the device explanted.On or around (b)(6) 2020, the patient experienced a thickened right axillary node which measured 9mm and a right periprosthetic lymphocele.The patient underwent a lymph node biopsy and was cd30+/alk-, suspicious for anaplastic large-cell lymphoma.The cytology results for the right-sided periprosthetic lymphocele fluid showed suspicious atypical cd30+/ema+ cells.The patient is scheduled for explantation around (b)(6) 2021.At the time of diagnosis, the patient had not had a mentor device implanted for over four years.However, this event is being reported out of an abundance of caution.Should more information be made available, a supplemental report will be submitted.This case is classified as a suspected, mixed history bia-alcl case, reported by the french health authority.Another manufacturer's implant (sebbin group) was implanted at the time of diagnosis for 4.5 years.Given the patient's implant history involving textured devices from multiple manufacturers, the disease cannot be attributed to any one manufacturer.

• Brand Name: MENTOR SILTEX CONTOUR PROFILE SPECTRUM
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 11634992
• Report Number: 1645337-2021-03772
• Device Sequence Number: 16993474
• Product Code: FWM
• UDI-Device Identifier: 00081317002147
• UDI-Public: 00081317002147
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1997
• Device Explanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/11/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2002
• Device Model Number: 3542512
• Device Catalogue Number: 3542512
• Device Lot Number: 157082
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 04/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 69 YR