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

Catalog Number	SMXP130RH
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/08/2018
Type of Reportable Event	Serious Injury
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) caucasian female patient underwent primary breast reconstruction with artoura breast tissue expander 475cc breast prosthesis.Deflation of the right expander was visually determined.As a result, the patient underwent removal and replacement with artoura breast tissue expander 475cc breast prosthesis on (b)(6) 2018.The patient experienced no accompanying symptoms.
Additional Manufacturer Narrative
On 6/14/2018, the mentor failure analysis lab has received the device for evaluation.On 7/4/2018, a device history record review was performed for the complaint device.As a result, the manufacturing date and expiration date fields have been updated.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.Device investigation summary: upon receipt by mentor, the device returned without fluid.No foreign material was observed within the device or on the shell surface.Upon initial inspection, the device appears intact.Leak testing was performed in accordance with mentor procedures and no leak sites were detected.No other anomalies were discovered.Complaint was not confirmed.The 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.There is no evidence that the issue is related with manufacturing.Tissue expanders 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).
Additional Manufacturer Narrative
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: 7584734
• Report Number: 1645337-2018-03539
• Device Sequence Number: 2355044
• Product Code: LCJ
• UDI-Device Identifier: 00081317024316
• UDI-Public: 00081317024316
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/18/2018

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: 03/09/2022
• Device Catalogue Number: SMXP130RH
• Device Lot Number: 7556304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2018
• Initial Date Received by Manufacturer: 05/18/2018
• Supplement Date Received by Manufacturer: 05/18/2018; 05/18/2018
• Initial Report FDA Received Date: 06/08/2018
• Supplement Report FDA Received Date: 07/06/2018; 07/06/2018
• 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: Required Intervention
• Patient Age: 32 YR