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

Model Number	3504307M
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation summary: the product was returned to mentor for evaluation.Mentor conducted a visual inspection and microscopic examination of the returned device.Visual analysis of the returned sample revealed that the tissue expander was found to have a tear at the union between the patch and shell.A microscopic examination was performed and the cause of the tear could not be identified.As the authorization form for examination was not received, the evaluation was limited to non-destructive testing; therefore, the shell thickness was not measured.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.Although no conclusion could be reached on the cause of the reported event, the instructions for use contain the following caution: causes of deflation of tissue expanders include but are not limited to the following events: crease fold failure, intraoperative or postoperative trauma, excessive stresses or manipulations as may occur during normal, daily routines including customary and purposeful trauma such as that which can occur during vigorous exercise, athletics, etc.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Reason for device explant and/or reoperation: deflation.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a female patient who had an unknown mentor tissue expander and a 550cc mentor tissue expander placed experienced bilateral deflation post procedure.As a result, explant was performed on (b)(6) 2022.See 1645337-2022-03645 for contralateral prosthesis report.

• 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 ; 6465917981
• MDR Report Key: 13978426
• Report Number: 1645337-2022-03644
• Device Sequence Number: 5440248
• Product Code: LCJ
• UDI-Device Identifier: 00081317002437
• UDI-Public: 00081317002437
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial

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: 12/15/2023
• Device Model Number: 3504307M
• Device Catalogue Number: 3504307M
• Device Lot Number: 9396935
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/09/2022
• Initial Report FDA Received Date: 04/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/17/2019
• 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
• Patient Sex: Female