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	11/12/2018
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.Manufacturer¿s reference number: (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 filled to 800cc and experienced deflation on the left side.Deflation was confirmed by physician during exam.As a result, the patient underwent removal and replacement with an artoura breast tissue expander 500cc, catalog number: smxp135rh, serial number: (b)(4), lot number: 7607879 on (b)(6) 2018.
Additional Manufacturer Narrative
Device evaluation summary: upon receipt by mentor, the device contained clear fluid.During initial evaluation the device appeared intact.Leak testing revealed a rent in length at the shell/doubler junction.A microscopic examination of the edges of the rent at the shell/doubler junction in the tissue expander revealed no indication as to its cause.No other anomalies were observed.Complaint was confirmed.Mentor products are 100% visually inspected prior to release in addition to thorough in-process testing during several stages of the manufacturing process.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.Because the risk of device deflation cannot be eliminated, mentor addresses this risk in the pids by stating that these devices should not be considered lifetime devices.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: 8130159
• Report Number: 1645337-2018-07199
• Device Sequence Number: 16587080
• Product Code: LCJ
• UDI-Device Identifier: 00081317024323
• UDI-Public: 00081317024323
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 11/13/2018

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: 09/28/2021
• Device Catalogue Number: SMXP135RH
• Device Lot Number: 7510868
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2018
• Initial Date Received by Manufacturer: 11/13/2018
• Supplement Date Received by Manufacturer: 12/12/2018
• Initial Report FDA Received Date: 12/04/2018
• Supplement Report FDA Received Date: 01/02/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR