MAUDE Adverse Event Report: MENTOR TEXAS ARTOURA BREAST TISSUE EXPANDER; EXPANDER, SKIN, INFLATABLE

Model Number	TEXP140RUH
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Capsular Contracture (1761); Necrosis (1971); Deformity/ Disfigurement (2360); Post Operative Wound Infection (2446); No Code Available (3191)
Date of Event	03/27/2018
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: acquired deformity nos, soft tissue necrosis, capsular contracture.(b)(4).Note: patient has the following history : athena.Breast cancer- left stage ii( (b)(6) 2015) , right stage in situ ((b)(6) 2015).Tissue expander (b)(6) 2016 mentor artoura ultra high profile.(b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old caucasian female patient who underwent breast reconstruction primary procedure with artoura breast tissue expander 850cc on the left breast implant and experienced the adverse events.She presented with breast tissue atrophy/chest wall deformity, which required flap reconstruction with tissue expander insertion.In addition, she presented with necrosis, which required flap reconstruction with tissue expander insertion.She also presented with breast pain, which required medication.Finally, she presented with baker iii capsular contraction, which required capsulotomy tissue expander removal with device replacement.As a result, the patient had undergone removal on (b)(6) 2018.
Additional Manufacturer Narrative
On 10/19/2020, mentor became aware that the awareness date in section g4 for this complaint was reported incorrectly.The actual awareness date was 7/30/2018.In addition, the date problem observed was reported incorrectly.The actual date problem observed was 3/27/2018.In addition, the sequence of events was erroneously omitted: the actual sequence of events was as following: on (b)(6) 2018, patient presents with breast tissue atrophy/chest wall deformity, requiring flap reconstruction surgery.This part of the event was inadvertently omitted from the initial report, and mentor found the error on 10/19/2020.Surgical intervention patient code was added.On (b)(6) 2018, patient presents with necrosis, requiring another flap reconstruction surgery.This part of the event was inadvertently omitted from the initial report, and mentor found the error on 10/19/2020 on (b)(6) 2018, patient presents with breast pain and swelling, requiring medication.On (b)(6) 2018, patient presents with baker grade iii capsular contracture, requiring medical device removal and replacement with mentor memorygel breast implant 500cc, catalog number: 3505001bc, serial number: (b)(6), lot number: 7604402 on (b)(6) 2019.H6 patient code 3191: surgical intervention.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
After clinical/secondary review of this file performed on 06/15/2021, it was decided to add code wound infection to more accurately capture the reported event.Manufacturer¿s reference number: (b)(4).After clinical/secondary review of this file performed on 06/15/2021, it was decided to add code wound infection to more accurately capture the reported event.

• Brand Name: ARTOURA BREAST TISSUE EXPANDER
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 10686383
• Report Number: 1645337-2020-13093
• Device Sequence Number: 10871968
• Product Code: LCJ
• UDI-Device Identifier: 00081317009573
• UDI-Public: 00081317009573
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/24/2020

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: 01/31/2022
• Device Model Number: TEXP140RUH
• Device Catalogue Number: TEXP140RUH
• Device Lot Number: 7542273
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/24/2020
• Supplement Date Received by Manufacturer: 10/19/2020; 06/15/2021
• Initial Report FDA Received Date: 10/15/2020
• Supplement Report FDA Received Date: 10/23/2020; 06/16/2021
• 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: 58 YR
• Patient Weight: 100