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

Model Number	SMXP110RUH
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	02/18/2020
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 is in progress.Once completed, a supplemental report will be submitted.Reason for device explant and/or reoperation: deflation.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old african american female patient who underwent a primary breast augmentation with 455cc artoura breast tissue expander experienced right-sided expander deflation postoperatively.The patient experienced a slow leak, and deflation was diagnosed via physical examination.As a result, the patient underwent explantation and replacement with 375cc artoura breast tissue expanders, catalog # smxp120rh, left lot-serial # (b)(4) and right lot-serial # (b)(4) on (b)(6) 2021.
Additional Manufacturer Narrative
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.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
The mentor failure analysis lab has completed the evaluation of the suspect medical device.Device evaluation summary: the product was returned to mentor for evaluation.Mentor conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the artoura ss, t exp, uhp,455cc had a crease/fold on the anterior view.Additionally, a tear was noted within the crease, measuring approximately 0.8 cm.Additionally, the shell looks to be blue.The evaluation determined that the cause of the rupture is consistent with normal wear.Deflation can occur at any time after implantation, but it is more likely to occur the longer the tissue expander is implanted.Creating wrinkles or folds should be avoided during implantation or other procedures as it can result in deflation at a later time.Tissue expander may also simply wear out over time.Regarding the blue color of the shell, multiple attempts have been made to obtain additional details regarding this event.However, no additional information has been made available.It should be noted that as part of mentor¿s quality process all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.A manufacturing record evaluation was performed for the finished device 9390651 number, and no non-conformances were identified.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: 11542263
• Report Number: 1645337-2021-02956
• Device Sequence Number: 3815325
• Product Code: LCJ
• UDI-Device Identifier: 00081317024378
• UDI-Public: 00081317024378
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K161176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/24/2021

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: 11/06/2023
• Device Model Number: SMXP110RUH
• Device Catalogue Number: SMXP110RUH
• Device Lot Number: 9390651
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2021
• Initial Date Received by Manufacturer: 02/24/2021
• Supplement Date Received by Manufacturer: 03/22/2021; 04/30/2021
• Initial Report FDA Received Date: 03/22/2021
• Supplement Report FDA Received Date: 04/06/2021; 05/04/2021
• 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: 45 YR