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

Model Number	SMXP120RUH
Medical Device Problem Codes	Off-Label Use (1494); Migration (4003)
Health Effect - Clinical Codes	Capsular Contracture (1761); No Code Available (3191)
Date of Event	03/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complaint device has been discarded.As a result, no product failure analysis can be conducted, and device malfunction cannot be confirmed.A manufacturing record evaluation is in progress.Once completed, a supplemental report will be submitted.Reason for device explant and/or reoperation: device migration, capsular contracture manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year old hispanic female patient who underwent primary breast reconstruction with two 535cc artoura breast tissue expanders, initially suffered left breast implant displacement when sutures dissolved or came loose on (b)(6) 2019, which was repaired and re-sutured.The patient also then developed bilateral capsular contracture; baker grade unknown.As a result, the patient underwent bilateral removal and replacement on (b)(6) 2019 with the following devices: (left) 490cc mentor memorygel breast implant catalog: shpx490 lot: 7676022 sn: (b)(4) and (right) 535cc mentor memorygel breast implant catalog: shpx560 lot: 7709731 sn: (b)(4).This medwatch form is for the left breast prosthesis.
Additional Manufacturer Narrative
After clinical/secondary review of this file performed on may 20, 2020, it was decided to remove device code 1494 (off-label use), to more accurately capture the reported event.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On (b)(6)2020, mentor became aware that device code 1494 (off-label use) was erroneously omitted from the initial report sent on (b)(6) 2020.The appropriate code has been filled.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
A manufacturing record evaluation (mre) was performed for the complaint device.The manufacturing record evaluation (mre) was reviewed, 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.Manufacturer¿s reference number: (b)(4).

• 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: 9931519
• Report Number: 1645337-2020-05373
• Device Sequence Number: 2808402
• Product Code: LCJ
• UDI-Device Identifier: 00081317024385
• UDI-Public: 00081317024385
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/19/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/24/2022
• Device Model Number: SMXP120RUH
• Device Catalogue Number: SMXP120RUH
• Device Lot Number: 7638962
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/19/2020
• Supplement Date Received by Manufacturer: 04/07/2020; 05/17/2020; 05/20/2020
• Initial Report FDA Received Date: 04/06/2020
• Supplement Report FDA Received Date: 04/08/2020; 05/18/2020; 05/21/2020
• 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: 70 YR