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

Model Number	SMXP150RH
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/21/2020
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 caucasian female who underwent primary breast reconstruction with a 750cc artoura breast tissue expander experienced right sided deflation post procedure.As a result, replacement with a new 750cc artoura breast tissue expander was performed on (b)(6) 2020.
Additional Manufacturer Narrative
The investigation of the returned device was completed by the failure analysis lab on april 15, 2020.Device evaluation summary: a manufacturing record evaluation was performed for the finished device number 9371285, and no non-conformances were identified.During visual evaluation no apparent damage or visual anomalies were observed on the returned device.Leak testing was performed, according with mentor procedures, and a tear was observed at the union between shell and suture tab, located at 3 o¿clock.Microscopic examination was performed, and the cause of the rupture could not be identified.It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.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: 9842318
• Report Number: 1645337-2020-04342
• Device Sequence Number: 2886753
• Product Code: LCJ
• UDI-Device Identifier: 00081317024347
• UDI-Public: 00081317024347
• 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: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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: 09/25/2023
• Device Model Number: SMXP150RH
• Device Catalogue Number: SMXP150RH
• Device Lot Number: 9371285
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2020
• Initial Date Received by Manufacturer: 02/25/2020
• Supplement Date Received by Manufacturer: 04/15/2020
• Initial Report FDA Received Date: 03/17/2020
• Supplement Report FDA Received Date: 04/16/2020
• 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: 40 YR