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

Catalog Number	SMXP155RH
Medical Device Problem Codes	Material Rupture (1546); Defective Component (2292); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/08/2019
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: deflation, defective valve.Concomitant medical products: left side; 850cc artoura breast tissue expander; catalog number: smxp155rh; serial number: (b)(4).Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) caucasian female patient underwent a primary breast augmentation with 850cc artoura breast tissue expander and was presented with right side deflation after implantation.Expander had a leak from where the valve expands itself.The issue was confirmed by the physician.As a result patient had the device removed and replaced with another device on (b)(6) 2019.
Additional Manufacturer Narrative
On 12/4/2019, a manufacturing record evaluation (mre) was performed, and no anomalies were found related to this complaint.In addition, the mre verifies that the device was manufactured in accordance with documented specification and procedures.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 (b)(6) 2020, device evaluation was completed.Device evaluation summary: during visual inspection of the device it was observed with no apparent damage.Leak testing was performed in accordance with mentor procedures and no leak sites were detected.The valve was found in good conditions.No anomalies were observed.During visual inspection of the device it was observed with no apparent damage.Leak testing was performed in accordance with mentor procedures and no leak sites were detected.The valve was found in good conditions.No anomalies were observed.Based on the information reported and/or the product investigation, there is no evidence that the issue is related with the manufacturing process.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 1/13/2020, device re-evaluation was performed.During visual inspection of the device it was observed with no apparent damage.Leak testing was performed and it revealed a rupture at the union between shell and patch.Microscopic examination was performed and no evidence of instrument damage was observed.No additional anomalies were observed.It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.Although the manufacturing criteria was met during manufacturing, there is an open investigation to address with the defects of the suture tabs on the tissue expander as seen by the customer.On 1/14/2020, mentor became aware that the device was received on 11/21/2019, not 12/4/2019 as reported under previous follow up 1 report.The device received date has been updated on this form.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: 9392664
• Report Number: 1645337-2019-24760
• Device Sequence Number: 16737166
• Product Code: LCJ
• UDI-Device Identifier: 00081317024354
• UDI-Public: 00081317024354
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/12/2019

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: 06/02/2023
• Device Catalogue Number: SMXP155RH
• Device Lot Number: 7727827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2019
• Initial Date Received by Manufacturer: 11/12/2019
• Supplement Date Received by Manufacturer: 12/04/2019; 01/10/2020; 01/13/2020
• Initial Report FDA Received Date: 12/01/2019
• Supplement Report FDA Received Date: 01/01/2020; 01/10/2020; 01/14/2020
• 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
• Patient Age: 42 YR