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 Consequences Or Impact To Patient (2199)
Date of Event	01/22/2018
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.A device history record review is in progress.Once completed, a supplemental report will be submitted.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) patient was being prepared for a primary breast augmentation procedure with a artoura breast tissue expander 500cc that deflated during surgery.Deflation was discovered prior to implantation and the device never came into contact with the patient.User facility had a backup device and the procedure was completed with no delay.The deflated device will be returned to mentor for analysis.
Additional Manufacturer Narrative
On 04/10/2018, 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.On 04/16/2018, mentor received additional information about the initial reporter.On 04/24/2018, the mentor failure analysis lab 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.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 04/24/2018, mentor received additional information about the event.It was originally reported that the deflation of the suspect medical device artoura breast tissue expander 500cc was discovered prior to implantation and the device never came into contact with the patient.New information states that a leak was discovered by the doctor during implantation surgery on (b)(6) 2018.Device was explanted on (b)(6) 2018.Deflated device did not leak into the patient.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 07/20/2018, mentor completed the investigation on the suspect medical device.Upon receipt by mentor, the device was received with clear fluid.Brown and white material was observed within the device.The device appeared intact.Because the authorization for return and examination of medical device form was not signed and/or returned to mentor, the product evaluation (pe) team was precluded from further evaluating the device.No anomalies were observed.Complaint was not confirmed.Mentor performs 100% inspection and testing of all devices prior to release.A root cause of the failure could not be determined.At this time is not possible to determine the origin of the brown and white material observed.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: 7287938
• Report Number: 1645337-2018-01017
• Device Sequence Number: 19161761
• Product Code: LCJ
• UDI-Device Identifier: 00081317024323
• UDI-Public: 00081317024323
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup,Followup
• Report Date (Section B): 01/24/2018

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: 10/01/2021
• Device Catalogue Number: SMXP135RH
• Device Lot Number: 7509627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2018
• Initial Date Received by Manufacturer: 01/24/2018
• Supplement Date Received by Manufacturer: 01/24/2018; 01/24/2018; 01/24/2018
• Initial Report FDA Received Date: 02/21/2018
• Supplement Report FDA Received Date: 05/03/2018; 05/13/2018; 07/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR