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

Catalog Number	SMXP135RH
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/03/2018
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 device history record review is in progress.Once completed, a supplemental report will be submitted.(b)(4).
Event or Problem Description
It was reported that a (b)(6)-year-old caucasian female patient underwent a breast reconstruction primary with an artoura breast tissue expander 500cc and experienced deflation on the right tissue expander.As a result, the patient had undergone removal and replacement with a artoura breast tissue expander 500cc on (b)(6) 2018.
Additional Manufacturer Narrative
On (b)(6) 2018, it was reported to mentor that the device history record (dhr) for the lot number 7546207 has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.(b)(4).
Additional Manufacturer Narrative
On 08/21/18, it was reported to mentor that the device evaluation and investigation have been completed.Upon receipt by mentor, the device contained clear fluid.The device appeared clean and intact upon initial examination.Leak testing, per mentor procedures, revealed no leakage sites in the device which may have contributed to the reported complaint.No anomalies were discovered.Complaint was not confirmed.Mentor performs 100% inspection and testing of all devices prior to release.A root cause failure analysis will not be conducted since the investigation of the reported failure could not confirm that an actual failure of the device to conform to expected performance had occurred.Because product evaluation team was unable to confirm any unusual failure mode, no corrective action will be taken at this time.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: 7733525
• Report Number: 1645337-2018-04614
• Device Sequence Number: 11398374
• Product Code: LCJ
• UDI-Device Identifier: 00081317024323
• UDI-Public: 00081317024323
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/12/2018

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: 02/25/2022
• Device Catalogue Number: SMXP135RH
• Device Lot Number: 7546207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2018
• Initial Date Received by Manufacturer: 07/12/2018
• Supplement Date Received by Manufacturer: 07/12/2018; 07/12/2018
• Initial Report FDA Received Date: 07/30/2018
• Supplement Report FDA Received Date: 08/02/2018; 08/22/2018
• 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: 51 YR