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

Model Number	SMXP130RUH
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/07/2020
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.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old female patient who underwent a primary breast reconstruction with a 650cc artoura breast tissue expander (left) and an unspecified tissue expander (right) experienced left-sided deflation and right-sided seroma postoperatively.As a result, the patient underwent bilateral removal and replacement with a 535cc mentor memorygel breast implant (left catalog #: shpx535, left serial #: (b)(4)) and a 490cc mentor memorygel breast implant (right catalog #: shpx490, right serial #: (b)(4)) on (b)(6) 2020.This report is for the left-sided prosthesis.
Additional Manufacturer Narrative
On 26-jun-2020, 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.Mentor received additional information regarding the date of event.The date is (b)(6) 2020.The relevant filed has been updated.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.On 14-jul-2020, mentor received additional information regarding the condition of the suspected medical device.The device was partially colored with blue/purple color due to the medical marking ink used during the implantation surgery.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
On (b)(6) 2020, the investigation on the suspected medical device was completed.Investigation summary : during visual evaluation, no apparent damage or visual anomalies were observed on the returned device.Leak testing was performed, and it revealed a tear at the juncture of the shell in anterior view and patch.In addition, microscopic examination was performed.However, the cause of the rupture could not be identified.As stated in the product insert data sheet, it is contraindicated to place drugs or substances inside the tissue expanders other than sterile saline for injection, since this could compromise the product integrity.Each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.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: 10120759
• Report Number: 1645337-2020-06892
• Device Sequence Number: 11224464
• Product Code: LCJ
• UDI-Device Identifier: 00081317024392
• UDI-Public: 00081317024392
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/14/2020

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 Expiration Date: 07/18/2023
• Device Model Number: SMXP130RUH
• Device Catalogue Number: SMXP130RUH
• Device Lot Number: 7747441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2020
• Initial Date Received by Manufacturer: 05/14/2020
• Supplement Date Received by Manufacturer: 06/26/2020; 07/24/2020
• Initial Report FDA Received Date: 06/04/2020
• Supplement Report FDA Received Date: 07/16/2020; 08/13/2020
• 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: 71 YR