MAUDE Adverse Event Report: MENTOR TEXAS MENTOR MEMORYGEL BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	3547001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Necrosis (1971); Seroma (2069); No Code Available (3191); Anaplastic Large Cell Lymphoma (3264)
Date of Event	09/25/2019
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: anaplastic large cell lymphoma, late onset seroma, soft tissue necrosis.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 (via fda mw5093336) that a (b)(6) year old female patient who underwent breast reconstruction revision with a 700cc mentor memorygel breast implants on (b)(6) 2015, presented with swelling, pain, and redness to her left reconstructed breast on (b)(6) 2019.The swelling increased in size over three weeks.As a result, the patient underwent an ultrasound guided aspiration of the seroma fluid procedure on (b)(6) 2019.The seroma fluid was tested, and the flow cytometry results showed a hypocellular sample with a population of cd30+ large t-cells.The findings were consistent with anaplastic large cell t-cell lymphoma.After testing of the seroma fluid, capsule, and breast tissue the patient was officially diagnosed with bia-alcl on (b)(6) 2019.As a result, the patient underwent bilateral removal on (b)(6) 2019.Should additional information become available, a supplemental report will be submitted.The implants and complete capsules were removed.The patient was not reconstructed after the treatment of alcl.The implants were not replaced.As of (b)(6) 2020, the patient is alive with no evidence of alcl.This medwatch form is for the left breast prosthesis.

• Brand Name: MENTOR MEMORYGEL BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 10059679
• Report Number: 1645337-2020-06253
• Device Sequence Number: 2849203
• Product Code: FTR
• UDI-Device Identifier: 00081317000952
• UDI-Public: 00081317000952
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date (Section B): 04/17/2020

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: 06/30/2019
• Device Model Number: 3547001
• Device Catalogue Number: 3547001
• Device Lot Number: 6840977
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/17/2020
• Initial Report FDA Received Date: 05/14/2020
• 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: 60 YR