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

Catalog Number	TEXP140RH
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Since the device has not been returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors can be made.As such, the investigation will be closed.If the complaint device is received in the future, the investigation will be reopened and conducted as appropriate.The device history record (dhr) was reviewed on 6/5/2018, 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.(b)(4).
Event or Problem Description
It was reported that a (b)(6) female patient underwent breast reconstruction with a artoura breast tissue expander 600cc.While implanting then inflating, the physician noted the tissue expander was leaking.As a result, the tissue expander was replaced intra-operatively with an artoura breast tissue expander 600cc.No patient consequence nor procedural delay was reported.
Additional Manufacturer Narrative
On 6/28/2018, mentor received additional information: explantation date: (b)(6) 2018.Implantation date: (b)(6) 2018.The mentor failure analysis lab received the device for evaluation on 6/22/2018.Device evaluation summary: the device was received at mentor without fluid.No foreign material was observed within the device or on the shell surface.Upon initial inspection, the device appeared intact.Leak testing of the device, in accordance with mentor procedures, revealed no leakage sites.No anomalies were observed.The complaint was not confirmed.Mentor performs 100% inspection and testing of all devices prior to release.A possible cause of the failure could not be determined.The device history record (dhr) for the lot number 7571477 has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.Breast implants are not considered lifetime devices and deflation is a known complication associated with these devices and is referenced in our product insert data sheet.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: 7589197
• Report Number: 1645337-2018-03615
• Device Sequence Number: 16499922
• Product Code: LCJ
• UDI-Device Identifier: 00081317009498
• UDI-Public: 00081317009498
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/16/2022
• Device Catalogue Number: TEXP140RH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2018
• Initial Date Received by Manufacturer: 05/24/2018
• Supplement Date Received by Manufacturer: 05/24/2018
• Initial Report FDA Received Date: 06/11/2018
• Supplement Report FDA Received Date: 07/13/2018
• 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
• Patient Age: 41 YR