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

Model Number	3341152
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Local Reaction (2035); Seroma (2069); Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA ALCL) (4549)
Date of Event	09/08/2021
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: suspected alcl, late onset seroma.Date of explantation: (b)(6) 2022.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) female patient underwent a primary breast reconstruction with a 345cc mentor memoryshape breast implant and experienced right-sided late onset seroma, surgical intervention, and suspected anaplastic large-cell lymphoma (alcl) postoperatively.On (b)(6) 2021, the patient started to experience symptoms of intermittent swelling and redness in her right breast.The breast would occasionally become red and swollen and spontaneously resolve.Magnetic resonance imaging (mri) was performed to evaluate the breast implants for 5-year screening.Based on the findings of the mri, it was recommended that ultrasound-guided aspiration be performed of the area in question.Ultrasound-guided fine needle aspiration of the right peri-implant fluid took place on (b)(6) 2021.A total of 5ml of clear, straw-colored yellow fluid was aspirated.Post-aspiration ultrasound showed the amount of peri-implant fluid to be decreased.There were no complications.The fluid was sent to cytology for analysis for cd30 and to rule out bia-alcl.The cytology report of the right breast fluid indicated that the cytological evaluation and cell block show rare large lymphocyte, in background of small lymphocytes, neutrophils, and macrophages.No clusters of marked atypical endothelial cells are identified.Rare cells are positive for cd30.Immunostains for cd3 and pax5 stains mixture of t and b lymphocytes.Cd68 stains the macrophages.Overall, in this limited specimen, these findings are atypical.If there is a concern for involvement by a neoplastic process, additional sampling/biopsy may be helpful if clinically indicated.Clinical and radiological correlation is recommended.In addition, a biopsy was performed on (b)(6) 2021 due to an enlarged right axillary lymph node.The biopsy result showed core fragments of lymph node, and no malignancy was seen.Based on all the findings, it was recommended for the patient to undergo complete removal of the capsules and implants.The explant/capsulectomy has been tentatively scheduled for (b)(6) 2022.It is not known whether the patient intends to get replacement implants in the future.Bia-alcl cannot be confirmed since the cytopathology is lacking and therefore inconclusive.Therefore, this case would be considered ¿suspected¿ bia-alcl.This case will be reassessed once the pathology report is provided.
Additional Manufacturer Narrative
On 2-dec-2021, mentor received additional information regarding the explantation date.Initially, the date of explantation was reported as (b)(6) 2022.However, additional information revealed that the patient is scheduled to undergo explantation on (b)(6) 2021.The relevant field has been updated.On 16-dec-2021, mentor received additional information regarding the patient¿s symptoms.Initially, alcl and late onset seroma were suspected.However, additional information (a pathology report was received) revealed that the patient experienced local reaction.The relevant field has been updated.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
On 5-jan-2022, the suspected medical device was returned for evaluation.On 24-jan-2022, the investigation on the suspected medical device was completed.On 24-jan-2022, it was found that updated reason for device explant and/or reoperation was omitted from the previous report.Investigation summary: mentor conducted a visual inspection of the returned device.During visual evaluation, no apparent damage or visual anomalies were observed on the returned device.Swelling is a temporary normal post-operative condition.Depending on presentation, delayed swelling may require additional work-up by the surgeon.Swelling is a known complication associated with these devices and is referenced in our current product insert data sheet.As part of mentor¿s quality process all devices are manufactured, inspected, and released to approved specifications.Manufacturer's reference number: (b)(4).Updated reason for device explant and/or reoperation: suspected alcl, suspected late onset seroma.

• Brand Name: MENTOR MEMORYSHAPE BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• 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: 12901385
• Report Number: 1645337-2021-13136
• Device Sequence Number: 4918615
• Product Code: FTR
• UDI-Device Identifier: 00081317005193
• UDI-Public: 00081317005193
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P060028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/04/2021

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: 06/26/2020
• Device Model Number: 3341152
• Device Catalogue Number: 3341152
• Device Lot Number: 6945584
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/04/2021
• Supplement Date Received by Manufacturer: 12/02/2021; 01/05/2022
• Initial Report FDA Received Date: 11/30/2021
• Supplement Report FDA Received Date: 12/23/2021; 01/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2015
• 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; Life Threatening
• Patient Age: 46 YR
• Patient Sex: Female