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

Model Number	SMXP130RH
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the time of this report, mentor has received no information regarding explantation or an expected explantation date.It is unknown at this time if the device will be made available for return.As a result, 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 (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.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) hispanic female patient underwent a breast reconstruction primary with mentor artoura breast tissue expander, 475cc saline breast implants which bilaterally deflated after implantation.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.This report is for the left side.
Additional Manufacturer Narrative
Additional information received on june 24th, 2020 indicates that the left side date of implantation was on (b)(6) 2019, and right side date of implantation was on (b)(6) 2019.On (b)(6) 2020 patient underwent bilateral removal and replacements as follow; left replaced with cat#:smxp130rh, sn#: (b)(6) , right sn#:(b)(6).This report is for the left side.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On june, 26th 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.Correction: date of explantation was on (b)(6) 2020.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Device evaluation completed on (b)(6) 2020: upon visual evaluation of the device, a tear was observed at the union between shell and suture tab at 6 o¿clock position.Additionally, injection dome delamination was noted.Microscopic examination was performed, and the cause of the rupture could not be identified.Each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.All the implants are 100% inspected before leaving the facility.There is no evidence that the issue is related with manufacturing breast implants are not considered lifetime devices and deflation is a known complication associated with these devices and is referenced in our product insert data sheet.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On july 31 2020, mentor reviewed the invoice document and decided to update "date of implantation" to (b)(6) 2019.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Updated device evaluation completed on april 29 , 2022 upon visual evaluation of the device, a tear was observed at the union between shell and suture tab at 6 o¿clock position.Additionally, injection dome delamination was noted.Microscopic examination was performed, and the cause of the rupture could not be identified.As part of our quality process, the manufacturing records of this lot-serial number were reviewed and the manufacturing standards were met prior to the release of this lot.Each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.Tissue expander deflation complaint information is consistently analyzed and monitored by mentor quality assurance to determine when further action is necessary.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
• Manufacturer (Section G): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer Contact: gabriel alfageme ; 3041 skyway circle north; irving, TX 75038 ; 949789-8687
• MDR Report Key: 9954288
• Report Number: 1645337-2020-05589
• Device Sequence Number: 2437472
• Product Code: LCJ
• UDI-Device Identifier: 00081317024316
• UDI-Public: 00081317024316
• 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: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 03/19/2020

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: 07/28/2023
• Device Model Number: SMXP130RH
• Device Catalogue Number: SMXP130RH
• Device Lot Number: 7755092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2020
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 03/19/2020
• Supplement Date Received by Manufacturer: 06/24/2020; 06/26/2020; 07/08/2020; 07/31/2020; 04/29/2022
• Initial Report FDA Received Date: 04/13/2020
• Supplement Report FDA Received Date: 06/30/2020; 07/06/2020; 07/09/2020; 08/04/2020; 05/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic
• Patient Race: White