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

Model Number	3545480
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Seroma (2069); Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA ALCL) (4549)
Date of Event	11/12/2020
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: bia-alcl, seroma aspiration.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported in the united states that a (b)(6) year-old female patient underwent revision breast augmentation with mentor memorygel breast implants 480cc and was diagnosed with breast implant associated anaplastic large cell lymphoma (bia-alcl) on the left breast.Per received ultrasound report, the patient presented with developed fullness, swelling in the left breast (in superior and inferior regions) and seroma in a diagnostic exam on (b)(6) 2020.On (b)(6) 2020, the patient underwent ultrasound-guided aspiration of the large peri-implant fluid in the left breast (collection about 120cc).Per cytologic evaluation on (b)(6) 2020, the morphological findings and immunohistochemical staining pattern are characteristic for breast implant associated anaplastic large cell lymphoma (bia-alcl), with cd30 expressed in atypical cells and alk not expressed in atypical cells.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.Follow-ups are in progress.If additional information is received, a supplemental report will be submitted.
Additional Manufacturer Narrative
On (b)(6) 2021, additional information was received indicating the patient underwent device removal on (b)(6) 2020.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.Manufacturer¿s reference number: (b)(4).

• 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: 11067257
• Report Number: 1645337-2020-16074
• Device Sequence Number: 2699958
• Product Code: FTR
• UDI-Device Identifier: 00081317007173
• UDI-Public: 00081317007173
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2020

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: 10/04/2017
• Device Model Number: 3545480
• Device Catalogue Number: 3545480
• Device Lot Number: 6639372
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/20/2020
• Supplement Date Received by Manufacturer: 02/23/2021
• Initial Report FDA Received Date: 12/23/2020
• Supplement Report FDA Received Date: 03/17/2021
• 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: Required Intervention
• Patient Age: 41 YR