MAUDE Adverse Event Report: MENTOR TEXAS ARTOURA UHP BREAST TE 535CC; EXPANDER, SKIN, INFLATABLE

Catalog Number	TEXP120RUH
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/01/2018
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.The device history record (dhr) was reviewed, 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.Concomitant products: left side : an artoura breast tissue expander 535cc , catalog number texp120ruh , serial number (b)(4), lot number 7546208.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old female patient underwent a breast augmentation with an artoura breast tissue expander 535cc and experienced right expander deflation.As a result, the patient had undergone removal without replacement on (b)(6) 2018.
Additional Manufacturer Narrative
On (b)(6) 2019, device evaluation and investigation have been completed.The device was received with clear.During evaluation the device appeared intact.Leak testing of the device, in accordance with mentor procedures, revealed a rent on the anterior aspect, measuring approximately 0.1 cm.Microscopic examination of the edges of the rent gave no indications of instrument damage.No other anomalies were observed.Complaint was confirmed.The complaint was confirmed since a rupture was found on the device.Nonetheless, a microscopic examination of the edges of the rent was performed and it did not provide conclusive evidence of what could be the root cause.The severity level for this complaint code was determined to be which is defined as: necessitates intrusive medical or surgical intervention.Because mentor product analysis lab 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 UHP BREAST TE 535CC
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 8219349
• Report Number: 1645337-2019-07775
• Device Sequence Number: 19246624
• Product Code: LCJ
• UDI-Device Identifier: 00081317009542
• UDI-Public: 00081317009542
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 12/17/2018

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: 02/07/2022
• Device Catalogue Number: TEXP120RUH
• Device Lot Number: 7546208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2018
• Initial Date Received by Manufacturer: 12/17/2018
• Supplement Date Received by Manufacturer: 02/08/2019
• Initial Report FDA Received Date: 01/04/2019
• Supplement Report FDA Received Date: 02/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR