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

Model Number	SMXP140RUH
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Crushing Injury (1797)
Date of Event	02/24/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The mentor failure analysis lab has received the device for evaluation.The analysis has begun but is not complete at this time.When the investigational analysis has been completed, a supplemental report will be submitted.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: material rupture.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year old caucasian female patient, who's undergone primary breast reconstruction with a 850cc artoura breast tissue expander on the left side, suffered breast implant deflation, post-procedure.The patient had surgery the week prior where she was placed face down on her stomach, and reportedly based on the patient's weight, they think this might have caused the deflation.The implant had a hole and the patient also noticed that it was not the same size.As a result, the patient underwent bilateral removal and then bilateral replacement on (b)(6) 2021 with the following devices: (right) 800cc mentor memorygel breast implant catalog: 3508001bc lot: 9494509 sn: (b)(4) and (left) 800cc mentor memorygel breast implant catalog: 3508001bc lot: 9410625 sn: (b)(4).
Additional Manufacturer Narrative
On (b)(6) 2021, the device investigation summary was updated as follows: the statement, "rupture can occur at any time after implantation, but it is more likely to occur the longer the implant is implanted," was updated to "deflation can occur at any time after implantation, but it is more likely to occur the longer the implant is implanted." manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On (b)(6) 2021, the product investigation was completed.Device investigation summary: the product was returned to mentor for evaluation.Mentor conducted a visual inspection and leak testing of the returned device.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the artoura ss, t exp, uhp 850cc breast implant.Leak testing was performed, in accordance with mentor procedures, and a tear was noted on the anterior view, measuring approximately 0.1 cm.The evaluation determined that the cause of the rupture is the trauma experienced.Rupture can occur at any time after implantation, but it is more likely to occur the longer the implant is implanted.Trauma is a known inherent risk of gel-filled mammary prosthesis.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.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: 11564035
• Report Number: 1645337-2021-03103
• Device Sequence Number: 4781692
• Product Code: LCJ
• UDI-Device Identifier: 00081317024415
• UDI-Public: 00081317024415
• 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: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/01/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/20/2024
• Device Model Number: SMXP140RUH
• Device Catalogue Number: SMXP140RUH
• Device Lot Number: 9454269
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2021
• Initial Date Received by Manufacturer: 03/01/2021
• Supplement Date Received by Manufacturer: 04/03/2021; 04/14/2021
• Initial Report FDA Received Date: 03/24/2021
• Supplement Report FDA Received Date: 04/05/2021; 04/15/2021
• 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: 46 YR