MAUDE Adverse Event Report: MENTOR TEXAS ARTOURA PLUS SMOOTH HIGH PROFILE 475CC; EXPANDER, SKIN, INFLATABLE

Model Number	SDC130H
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	04/06/2022
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.If certain information is unknown, not available or does not apply, the section/field of the form is left blank.Reason for device explant and/or reoperation: deflation.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a female patient underwent an unspecified breast implantation procedure with an artoura plus smooth high profile 475cc and experienced deflation (side unknown) post-operatively.As a result, the patient underwent removal on (b)(6) 2021.The device serial number was reported as (b)(4); however, this serial number is not associated with any current mentor products.
Additional Manufacturer Narrative
A photo of the device was returned for evaluation.Photo evaluation summary: upon visual evaluation of the image provided in the complaint, the device was observed deflated.As the product involved in this complaint was discarded, the device couldn´t be analyzed according to our procedures.As part of mentor¿s quality process all devices are manufactured, inspected, and released to approved specifications.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On apr 29, 2022, additional information was received.The date of event was identified as apr 6, 2022.The procedure was identified as a reconstruction primary.Patient's age was identified as 63 years old.The patient's race is caucasian.The device serial number was identified as (b)(6).The deflation was found to have occurred on the left side.The date of implantation was identified as (b)(6) 2021.On may 4, 2022, the explantation date was identified as (b)(6) 2022.Manufacturer¿s reference number: (b)(4).

• Brand Name: ARTOURA PLUS SMOOTH HIGH PROFILE 475CC
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• 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: michelleann garcia ; 3041 skyway circle north; irving, TX 75038 ; 6465917981
• MDR Report Key: 14227395
• Report Number: 1645337-2022-04799
• Device Sequence Number: 17191943
• Product Code: LCJ
• UDI-Device Identifier: 10081317028243
• UDI-Public: 10081317028243
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K161176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup

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: 10/19/2025
• Device Model Number: SDC130H
• Device Catalogue Number: SDC130H
• Device Lot Number: 9643685
• 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: 04/06/2022
• Supplement Date Received by Manufacturer: 04/29/2022; 05/30/2022
• Initial Report FDA Received Date: 04/27/2022
• Supplement Report FDA Received Date: 05/20/2022; 06/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/20/2021
• 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 Age: 63 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White