MAUDE Adverse Event Report: MENTOR TEXAS MENTOR MEMORYSHAPE BREAST IMPLANT

Catalog Number 3341507

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Seroma (2069); No Code Available (3191); Anaplastic Large Cell Lymphoma (3264); Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA ALCL) (4549)

Event Date 07/21/2017

Event Type  Injury  

Manufacturer Narrative

No device was received for analysis at the time of submission of the initial 3500a.   since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.As such, the investigation will be closed.If the complaint device is received in the future, we will reopen the complaint and perform the investigation as appropriate.The device history record (dhr) of lot number 6871997 was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.(b)(4).

Event Description

It was reported by a physician that a (b)(6) year old female patient was diagnosed with alcl on (b)(6) 2017.This patient¿s medical history includes diagnosis of left breast invasive ductal carcinoma in (b)(6) 2015.She underwent bilateral mastectomy and bilateral tissue expander placement in (b)(6) 2015.The patient had mentor tissue expanders that were implanted from (b)(6) 2015.The patient then had mentor memory shape low high moderate plus profile breast implants (catalog #334-1507, r.Side serial # (b)(4)) implanted in (b)(6) 2015.On (b)(6) 2017, the patient experienced a large right breast effusion that developed over 24-48 hours.The effusion was aspirated and tested using flow cytometry and cd30 ihc and came back positive for bia-alcl on (b)(6) 2017.The time between patient signs/symptoms of peri-implant alcl to definitive diagnosis was 1 week.The patient did not have any complications such as infection, hematoma, or implant rotation during implant course prior to alcl diagnosis.The patient did not experience skin lesions, fevers, night sweats or weight loss.There was no pain, redness, palpable breast mass, or capsular contracture.The lymphoma cells were found in the seroma fluid surrounding the implant.Immunohistochemical and flow cytometry testing showed alk negative and cd30 positive results.This is a pathologically confirmed stage ie primary diagnosis of alcl.Based on histology, there is no capsular involvement.The lymphoma cells were found in the effusion fluid surrounding the implant.The patient underwent bilateral implant removal and capsulectomies with no implant replacement on (b)(6) 2017.The implants were intact and not ruptured upon removal.

Manufacturer Narrative

On july 8, 2020, mentor became aware that following information was inadvertently not reported or incorrectly reported under the previous initial submission on september 6, 2017.The information has been corrected on this form.(b)(4).Reason for device explant and/or reoperation: right side anaplastic large-cell lymphoma manufacturer¿s reference number: (b)(4).

Manufacturer Narrative

After clinical/secondary review of this file performed on (b)(6), 2023, it was decided to add late onset seroma and surgical intervention, to more accurately capture the reported event.Per the legal document provided and review performed, on (b)(6), 2017 the patient had fluid aspirated from her right breast where a seroma had developed.The pathology results were positive for bia-alcl.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: right side anaplastic large-cell lymphoma, late onset seroma, and surgical intervention manufacturer¿s reference number: (b)(4) codes updated added under section h per clinician's review.

Manufacturer Narrative

Additional information received on june 12, 2023.Per the information provided, and reviewed by the clinician, the patient had the implants placed on (b)(6) 2017.In addition, there was also the presence of bia-alcl in the right axillary lymph node.Manufacturer¿s reference number: (b)(4).

Manufacturer Narrative

On november 21, 2023, mentor became aware that incorrect year was mistakenly reported under filed h10 follow up number 3 report.It should have said (b)(6) 2015 not 2017.The year was correct under field d6a.Manufacturer¿s reference number: (b)(4), incorrect year for date under filed h10 follow up number 3 report.

Manufacturer Narrative

Complete udi number has been added to field d4 on this form.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYSHAPE BREAST IMPLANT
• Type of Device: BREAST IMPLANT
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer Contact: joaquin kurz ; 3041 skyway circle north; irving, TX 75038 ; 949789-383
• MDR Report Key: 6847224
• MDR Text Key: 85081442
• Report Number: 1645337-2017-00103
• Device Sequence Number: 1
• Product Code: FTR
• UDI-Device Identifier: 81317004998
• UDI-Public: (01)81317004998(11)141023(17)191022(10)6871997
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/10/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 10/22/2019
• Device Catalogue Number: 3341507
• Device Lot Number: 6871997
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/10/2017
• Initial Date FDA Received: 09/06/2017
• Supplement Dates Manufacturer Received: 07/08/2020; 03/16/2023; 06/12/2023; 11/21/2023; 08/05/2024
• Supplement Dates FDA Received: 07/23/2020; 03/19/2023; 07/06/2023; 11/21/2023; 08/05/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/23/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White