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

Model Number	3504304M
Medical Device Problem Codes	Off-Label Use (1494); Material Rupture (1546); Use of Device Problem (1670)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/24/2018
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.Since no lot number was provided, no device history record (dhr) review could be performed.(b)(6).(b)(4).
Event or Problem Description
It was reported that a (b)(6)-year-old female patient who underwent a primary breast reconstruction procedure with a mentor tissue expander 700cc device on 09/28/2016 noticed sudden loss of volume in her right breast.The patient denies that there was any trauma or other intercurrences.During a physical examination, it was observed that there was a loss of volume in the tissue expander.As a result, the patient underwent explantation and replacement with a mentor tissue expander 700cc device on (b)(6) 2018.During explantation surgery, it was verified there was a fissure in the suspect medical device.
Additional Manufacturer Narrative
On (b)(6) 2018, the mentor product 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) 2019, mentor completed the investigation on the suspect medical device.Upon receipt by mentor, the device returned without fluid.No foreign material was observed within the device or on the shell surface.Mentor product analysis lab discovered a rent at the patch junction.Microscopic examination of the edges of the rent gave no indications as to cause.No other anomalies were discovered.The complaint was confirmed since a rupture was found on the device.However, at this point it is not possible to determine the root cause of such damage.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; however, deflation trends for mentor saline-filled devices will continue to be monitored by quality assurance.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
After additional review of this event by mentor's clinical safety and regulatory teams on 22-jul-2022, it has determined that the device was not used off-label.As a result, medical device problem code off-label use no longer applies.The device was implanted longer than six months, which is not in accordance with our instructions for use.Therefore h6 medical device problem code a23/use of device problem has been added.Manufacturer's reference number: (b)(6) h6 medical device problem code off-label use was replaced with a23/use of device problem.

• Brand Name: MENTOR 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: 8048784
• Report Number: 1645337-2018-06692
• Device Sequence Number: 11131140
• Product Code: LCJ
• UDI-Device Identifier: 00081317002406
• UDI-Public: 00081317002406
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K842883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/17/2018

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 Model Number: 3504304M
• Device Catalogue Number: 3504304M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2018
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 10/17/2018
• Supplement Date Received by Manufacturer: 11/09/2018; 01/13/2019; 07/22/2022
• Initial Report FDA Received Date: 11/07/2018
• Supplement Report FDA Received Date: 11/28/2018; 01/14/2019; 08/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female