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

Catalog Number	TEXP140RH
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The mentor failure analysis lab received the device for evaluation on (b)(6) 2018.The analysis has begun, but is not complete at this time.When the investigation and analysis have been completed, a supplemental report will be submitted.The device history record (dhr) was reviewed on (b)(6) 2018, and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.(b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old female patient underwent primary breast augmentation with a artoura breast tissue expander 600cc.Deflation on the left breast tissue expander was diagnosed post procedure.As a result, the patient underwent unilateral removal and replacement with a artoura breast tissue expander 600cc on (b)(6) 2018.
Additional Manufacturer Narrative
Device evaluation summary: it was reported that a (b)(6) year-old female patient underwent primary breast augmentation with a artoura breast tissue expander 600cc.Deflation on the left breast tissue expander was diagnosed post procedure.As a result, the patient underwent unilateral removal and replacement with a artoura breast tissue expander 600cc on (b)(6) 2018.The device was received at mentor with clear fluid.No foreign material was observed within the device or on the shell surface.The product evaluation team discovered a rent measuring approximately < 0.1cm on the anterior aspect.No other anomalies were discovered.Because the authorization for return and examination of medical device form was not signed and/or returned to mentor, the product evaluation team was precluded from further evaluating the device.The complaint was confirmed since a rupture was found on the device.However, at this point it is not possible to determine the root cause of such damage.There is no evidence that the issue is related with manufacturing.Breast implants are not considered lifetime devices and deflation is a known complication associated with these devices and is referenced in our product insert data sheet.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: 7478510
• Report Number: 1645337-2018-02579
• Device Sequence Number: 1963804
• Product Code: LCJ
• UDI-Device Identifier: 00081317009498
• UDI-Public: 00081317009498
• 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: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2018

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: 05/18/2019
• Device Catalogue Number: TEXP140RH
• Device Lot Number: 6930938
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2018
• Initial Date Received by Manufacturer: 04/10/2018
• Supplement Date Received by Manufacturer: 04/10/2018
• Initial Report FDA Received Date: 05/01/2018
• Supplement Report FDA Received Date: 06/06/2018
• 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: 39 YR