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

Model Number	SMXP130RH
Medical Device Problem Codes	Material Rupture (1546); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complaint device has been discarded.As a result, no product failure analysis can be conducted, and device malfunction cannot be confirmed.A manufacturing record evaluation is in progress.Once completed, a supplemental report will be submitted.Reason for device explant and/or reoperation: na.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old caucasian female who underwent primary breast reconstruction with artoura breast tissue expander 475cc saline prosthesis experienced left sided procedure delay intraoperatively.The report indicated that the surgeon had to operate and replace an expander.The surgeon attempted to fill the expander and the butterfly when through the buffer zone and not the port and the expander deflated.The surgeon did not save the explanted expander but had to replace it, and this delayed the procedure by 30 minutes.The procedure completed by using a new mentor artoura smooth hp 475cc expander.No signs or patient symptoms reported.
Additional Manufacturer Narrative
On march 4, 2021 mentor became aware that unintentionally miss coded the initial report with manufacturer report number:1645337-2021-00370, and error on h6.Manufacturer¿s reference number: (b)(4).6.Medical device problem code: the correct code is material rupture which happened intraoperatively.H6.Type of investigation: device discarded.
Additional Manufacturer Narrative
On (b)(6) 2021, a search of the lot number was done and an mre could not be located if additional information becomes available a supplemental will be submitted 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: 11167392
• Report Number: 1645337-2021-00370
• Device Sequence Number: 3659070
• Product Code: LCJ
• UDI-Device Identifier: 00081317024316
• UDI-Public: 00081317024316
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/21/2020

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 Model Number: SMXP130RH
• Device Catalogue Number: SMXP130RH
• Device Lot Number: 949474
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/21/2020
• Supplement Date Received by Manufacturer: 02/17/2021; 03/04/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 02/18/2021; 03/08/2021
• 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: 58 YR