MAUDE Adverse Event Report: MENTOR TEXAS MENTOR MEMORYSHAPE¿ TH 485CC; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Model Number	3341254
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wrinkling (2613); Breast Discomfort/Pain (4504); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2021
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: as of now there is no information regarding the explant or reoperation.Na.(b)(4).Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a caucasian female who underwent an unspecified breast reconstruction surgery with mentor memoryshape breast, 485cc silicone prosthesis, experienced bilateral procedural dissatisfactions postoperative.As a result, patient underwent bilateral mastopexies on (b)(6) 2020.The report indicated that the outcome resolved.This report relates to the right prosthesis.
Additional Manufacturer Narrative
According to the information retrieved from imedidata on november 30, 2021, procedure type was updated to ¿breast reconstruction revision¿.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Additional information received on november 15, 2022 indicated that the customer reported dissatisfaction, therefore added patient code "no signs, symptoms or patient involvement" since there's no clinical symptom nor sign reported for this event and the patient is not experiencing any harms related to the issue.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
[adverse event review clinical note and patient coding verification]: coding was reviewed by a clinician on sep-19-2024 per 100553403 and 100553401 with the available information about the reportable event.Added pc - patient dissatisfaction with procedure outcome to both ips per the information provided in imedidata.Adverse event #3 right/ left side, implant serial number: (b)(6).During the 5 year follow-up visit on (b)(6) 2024 the patient again reported dissatisfaction with procedure outcome.At this time, mentor has received very limited information regarding this event, based on the information provided in edc (imedidata) the patient suffered breast rippling (wrinkling) and breast pain.H6 health effect - clinical code e2402: patient dissatisfaction.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Additional information received on september 10, 2024, indicated that patient experienced bilateral implant wrinkling and that is the reason patient is unsatisfied with the implants.Patient has difficulty sleeping because of discomfort in breast area, therefore removed patient code patient dissatisfaction with procedure outcome from (b)(4).Added patient codes breast pain and cutaneous contour deformity on (b)(4).Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYSHAPE¿ TH 485CC
• 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: 12050048
• Report Number: 1645337-2021-07104
• Device Sequence Number: 19708765
• Product Code: FTR
• UDI-Device Identifier: 00081317024231
• UDI-Public: 00081317024231
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 05/31/2021

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: 04/17/2023
• Device Model Number: 3341254
• Device Catalogue Number: 3341254
• Device Lot Number: 7568877
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/31/2021
• Supplement Date Received by Manufacturer: 11/30/2021; 11/15/2022; 09/20/2023; 10/04/2023; 09/10/2024; 09/19/2024
• Initial Report FDA Received Date: 06/23/2021
• Supplement Report FDA Received Date: 12/08/2021; 11/28/2022; 09/27/2023; 10/10/2023; 09/19/2024; 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/19/2018
• 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
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White