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

Model Number	SMXP155RH
Medical Device Problem Codes	Material Rupture (1546); Defective Component (2292)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/16/2019
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 (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: deflation, defective valve.Concomitant medical products: mentor artoura breast tissue expander 850cc saline device, cat#: smxp155rh sn#: (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 mentor artoura breast tissue expander 850cc saline device which the left side deflated 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
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.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Device evaluation summary: during visual inspection of the device it was observed with no apparent damage.Leak testing revealed there was a tear in the third suture tab.Valve was observed with no leaks.Microscopic examination was performed to the rupture 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 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.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
Updated device evaluation completed on november11, 2020: during visual inspection of the device it was observed with no apparent damage.Leak testing revealed there was a tear in the third suture tab.Microscopic examination was performed to the rupture and no evidence of instrument damage was observed.No additional anomalies were observed.Asymmetry may be attributed to one or more of the following: contracture of the fibrous capsule, seroma or hematoma, development of postoperative breast dysplasia, unilateral discrepancy in muscle development, deflation of the implant, incorrect choice of implant shape or size, and surgical technique.Asymmetry is a known complication associated with these devices and is referenced in our current product insert data sheet.It should be noted that as part of our quality process, each device is visually inspected 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.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
¿after clinical/secondary review of this file performed on (b)(6) 2020, it was decided to remove defective valve, and add broken suture tab to more accurately capture the reported event.¿ updated device summary evaluation completed on (b)(6) 2020.During visual inspection of the device it was observed with no apparent damage.Leak testing revealed there was a tear in the third suture tab.Microscopic examination was performed to the rupture 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 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.All the implants are 100% inspected before leaving the facility.There is no evidence that the issue is related with manufacturing manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On july 30 2020, mentor received additional information indicating that post-op follow up on (b)(6) 2019 demonstrated deflating right breast expander.Immediate new fluid collection was noted of the right breast.Superficial aspiration removed 60 cc.This is confirming a leak of the expander.On (b)(6) 2019 bilateral breast replacement of tissue expander with permanent silicone implants 3508004bc performed.This report is for the left side.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On august 6 2020 mentor became aware that mistakenly missed reporting some information in manufacturer report number 1645337-2019-23494 as follow, b2, d7 and h6 were not selected.This report contains the missed information.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: 9305954
• Report Number: 1645337-2019-23494
• Device Sequence Number: 11270245
• 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,Followup
• Report Date (Section B): 10/21/2019

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 Model Number: SMXP155RH
• 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: 10/21/2019
• Supplement Date Received by Manufacturer: 11/21/2019; 12/16/2019; 01/13/2020; 08/06/2020; 08/06/2020; 11/12/2020
• Initial Report FDA Received Date: 11/11/2019
• Supplement Report FDA Received Date: 12/10/2019; 12/17/2019; 01/22/2020; 08/06/2020; 08/06/2020; 11/13/2020
• 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: 42 YR