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

Model Number	3504311M
Medical Device Problem Codes	Peeled/Delaminated (1454); Material Rupture (1546)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/14/2023
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: currently unknown.E1 initial reporter phone: (b)(6).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).
Event or Problem Description
It was reported that a patient underwent an unspecified surgery with a mentor tissue expander 700cc device that deflated post implantation.It was reported that there was a tear and that the base was completely separated from one of the sides.
Additional Manufacturer Narrative
On 01-aug-2023, mentor received additional information about the event: the patient underwent a body tissue expansion procedure to treat a burn with the suspect medical device.An updated date of event (14-jun-2023) was reported.The implantation date is (b)(6) 2023.The explantation date is (b)(6) 2023.The complaint device has been discarded.As a result, no product failure analysis can be conducted, and device malfunction cannot be confirmed.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 26-sep-2023, mentor completed the investigation on the suspect medical device.The investigation was completed on a photo of the suspect medical device because the physical device has not been received by mentor.Device evaluation summary: according to the information received, the patient experienced a deflation in the tissue expander.It was reported that there was a tear and that the base was completely separated from one of the sides.Upon visual evaluation of the image provided in the complaint, the expander was observed delaminated from the base.As the product involved in this complaint was discarded, the device couldn't be analyzed according to our procedures.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.According to manufacturing investigation in conclusion, with consideration to the process controls, the initial evaluation performed by the complaint handling team, data records reviewed for the complaint devices and the lack of the physical evaluation of the device due to it was not received, the delamination reported on is not able to be confirmed as manufacturing defect and the cause of the delamination could not be confirmed.As part of mentor¿s quality process all devices are manufactured, inspected, and released to approved specifications.Capa activity was not required.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post market surveillance.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: kate karberg ; 3041 skyway circle north; irving, TX 75038 ; 3035526892
• MDR Report Key: 17283665
• Report Number: 1645337-2023-08059
• Device Sequence Number: 14998938
• Product Code: LCJ
• UDI-Device Identifier: 00081317002475
• UDI-Public: 00081317002475
• Combination Product (Y/N): N
• Initial Reporter Country: JO
• PMA/510(K) Number: K842883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,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 Model Number: 3504311M
• Device Catalogue Number: 3504311M
• Device Lot Number: 9832494
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/22/2023
• Supplement Date Received by Manufacturer: 08/01/2023; 09/26/2023
• Initial Report FDA Received Date: 07/07/2023
• Supplement Report FDA Received Date: 08/18/2023; 09/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2023
• 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: Unknown