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

Catalog Number	TEXP135RH
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Code Available (3191)
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
On (b)(6) 2018, artoura breast tissue expander 500cc was received by the mentor failure analysis lab with no accompanying information.The device was processed on (b)(6) 2018.The device could not be associated with an existing complaint.In the absence of clarifying information, it cannot be determined why this device was returned to mentor.However, it will be conservatively reported to fda as an event requiring medical device removal from a patient.
Additional Manufacturer Narrative
On (b)(6) 2018, it was reported to mentor that the device history record (dhr) for the lot number 7558810 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 returned without fluid.No foreign material was observed within the device or on the shell surface.Product evaluation team discovered two rents.Rent a was measured approximately 1 cm and rent b measuring approximately 0.9 cm; both located on the anterior aspect.No other anomalies were discovered.Complaint could not be confirmed since there is no event to compare with.At this point, is not possible to determine a root cause of such damage.All the implants are 100% inspected before leaving the facility.There is no evidence that the issue is related with manufacturing.There is no evidence that the issue is related with manufacturing.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: 7759690
• Report Number: 1645337-2018-04784
• Device Sequence Number: 1319882
• Product Code: LCJ
• UDI-Device Identifier: 00081317009481
• UDI-Public: 00081317009481
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/15/2022
• Device Catalogue Number: TEXP135RH
• Device Lot Number: 7558810
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2018
• Initial Date Received by Manufacturer: 07/18/2018
• Supplement Date Received by Manufacturer: 07/18/2018; 07/18/2018
• Initial Report FDA Received Date: 08/07/2018
• Supplement Report FDA Received Date: 08/09/2018; 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: Other; Required Intervention