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)
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 manufacturing record evaluation is in progress.Once completed, a supplemental report will be submitted.Reason for device explant and/or reoperation: concomitant products: manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a patient who had a 750cc artoura breast tissue expander experienced left sided deflation post procedure.As a result, device replacement with another 750cc artoura breast tissue expander was performed on (b)(6) 2019.No additional details are available at this time, if additional details are made available in the future, then a supplemental report will be submitted.
Additional Manufacturer Narrative
A manufacturing record evaluation (mre) was performed for the finished device number (b)(6), and no non-conformances related to the reported complaint condition were identified.Manufacturer¿s reference number: (b)(6).

• 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: 9505791
• Report Number: 1645337-2019-26013
• Device Sequence Number: 1305077
• Product Code: LCJ
• UDI-Device Identifier: 00081317024347
• UDI-Public: 00081317024347
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2019

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: 11/18/2022
• Device Model Number: SMXP150RH
• Device Catalogue Number: SMXP150RH
• Device Lot Number: 7650654
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/27/2019
• Supplement Date Received by Manufacturer: 01/22/2020
• Initial Report FDA Received Date: 12/20/2019
• Supplement Report FDA Received Date: 01/23/2020
• 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