MAUDE Adverse Event Report: MENTOR TEXAS ARTOURA PLUS SMOOTH HIGH PROFILE; EXPANDER, SKIN, INFLATABLE

Model Number	SDC130H
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Fall (1848); Hematoma (1884)
Date of Event	04/11/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The mentor failure analysis lab has 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.A manufacturing record evaluation is in progress.Once completed, a supplemental report will be submitted.Reason for device explant and/or reoperation: deflation, hematoma.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old african american female patient who underwent primary breast reconstruction surgery with a 475cc artoura plus smooth high profile tissue expander experienced deflation and seroma post procedure.On an unspecified date, patient¿s cat jumped on her chest causing the deflation.As a result, patient underwent removal and replacement with a like device on (b)(6) 2021.
Additional Manufacturer Narrative
On may 10, 2021, mentor became aware that d4 lot number was erroneously omitted in initial report.Refer to corrected data section for corrections.Manufacturer¿s reference number: (b)(4).D4.Lot relevant field was added.A manufacturing record evaluation was performed for the finished device (b)(4) number, and no non-conformances were identified.
Additional Manufacturer Narrative
On (b)(6) 2021, the mentor failure analysis lab has 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.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.Patient had an explantation on (b)(6) 2021.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
The investigation of the returned device was completed by the failure analysis lab on june 10, 2021.Device evaluation summary: according to with the information received, the patient experienced deflation in the artoura plus smooth high profile 475cc tissue expander and developed a hematoma due to a chest injury, since the cat jumped on her breast.The product was returned to mentor for evaluation.Mentor conducted a visual inspection and leak testing of the returned device.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the artoura plus smooth high profile 475cc tissue expander.Leak testing was performed, in accordance with mentor procedures, and no leak sites were detected during the analysis.The event described could not be confirmed as the tissue expander was returned without detectable damage.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.Manufacturer¿s reference number: (b)(4).

• Brand Name: ARTOURA PLUS SMOOTH HIGH PROFILE
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 11803376
• Report Number: 1645337-2021-05170
• Device Sequence Number: 14327606
• Product Code: LCJ
• UDI-Device Identifier: 10081317028243
• UDI-Public: 10081317028243
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K161176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/12/2021

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: 10/18/2024
• Device Model Number: SDC130H
• Device Catalogue Number: SDC130H
• Device Lot Number: 9507605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2021
• Initial Date Received by Manufacturer: 05/10/2021
• Supplement Date Received by Manufacturer: 05/10/2021; 05/06/2021; 06/10/2021
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 05/10/2021; 06/03/2021; 06/11/2021
• 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: Required Intervention
• Patient Age: 30 YR