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

Model Number	3504310M
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Deformity/ Disfigurement (2360); Insufficient Information (4580)
Date of Event	05/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a female who underwent an unknown breast surgery with an unknown mentor tissue expander breast implant, experienced unknown sided deflation postoperative.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.
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.Since no lot number was provided, no manufacturing record evaluation review could be performed.Reason for device explant and/or reoperation: na.Mentor is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which mentor has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, mentor, or its employees that the report constitutes an admission that the device, mentor, or its employees caused or contributed to the potential event described in this report.If certain information is unknown, not available or does not apply, the section/field of the form is left blank.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Per additional event information received on june 27, 2022: the following fields were populated/modified.Event date as may 15, 2022.Tx lot/serial number (b)(6).Date of implant as mar 30, 2022.Date of explant as june 9, 2022.Associated products as no replacement.Updated patient codes from no information available and insufficient information to anisomastia and medical device removal.A manufacturing record evaluation is in progress.Once completed, a supplemental report will be submitted.Manufacturer¿s reference number: (b)(4).
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 (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.Manufacturer¿s reference number: pc-(b)(4).
Additional Manufacturer Narrative
Device evaluation completed on october 25 , 2022: the product was returned to mentor for evaluation.Mentor then conducted a visual inspection, microscopic examination, and thickness measurement of the returned device.Visual analysis of the returned sample revealed that the exp rect remote 550cc tissue expander was found to have a tear on the union between shell and patch.A microscopic examination was performed and the cause of the deflation could not be identified.Therefore a thickness measurement was conducted on the shell at the tear, and the thickness was within manufacturing specifications.Based on the information currently available, a product issue was identified during the investigation of the sample received.This product issue was addressed through mentor¿s quality system.Manufacturer¿s reference number: (b)(4).

• 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: michelleann garcia ; 3041 skyway circle north; irving, TX 75038 ; 646591-7981
• MDR Report Key: 14704060
• Report Number: 1645337-2022-07041
• Device Sequence Number: 19383671
• Product Code: LCJ
• UDI-Device Identifier: 00081317002468
• UDI-Public: 00081317002468
• Combination Product (Y/N): N
• PMA/510(K) Number: K842883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup

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: 04/16/2024
• Device Model Number: 3504310M
• Device Catalogue Number: 3504310M
• Device Lot Number: 9430302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/23/2022
• Supplement Date Received by Manufacturer: 06/27/2022; 07/22/2022; 10/25/2022
• Initial Report FDA Received Date: 06/15/2022
• Supplement Report FDA Received Date: 07/07/2022; 07/28/2022; 10/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2020
• 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: Other; Required Intervention
• Patient Sex: Female