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

Model Number	3504305M
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2020
Type of Reportable Event	Malfunction
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: n/a.(b)(4).
Event or Problem Description
It was reported that a mentor tissue expander 400cc device deflated during an unspecified breast surgery procedure.It was observed that the expander was punctured and there was saline solution leakage.The device was not implanted in a patient and there was no reported patient consequence.
Additional Manufacturer Narrative
On 24-oct-2024, the mentor failure analysis lab received the device for evaluation.On 28-oct-2024, mentor completed the investigation on the suspect medical device.Device evaluation summary: according to the information received, leakage of the saline solution was observed when attempting to implant the expander.The product was returned to mentor for evaluation.Mentor then conducted a visual inspection, leak testing, and microscopic examination of the returned device.Visual analysis of the returned sample determined that the tissue expander was painted blue.Additionally, the injection dome was received separately.Leak testing was performed, according to the mentor procedure, and two (2) tears (a & b) were found on the anterior view, measuring approximately 0.1 cm each.No other leak sites were found during the analysis.Microscopic examination was performed on the edges of the ruptures (a & b), and parallel striations were found in the whole area of both tears.Parallel striations are consistent with markings made by a sharp object perforating the tissue expander shell.Based on the information currently available, the microscopic examination of the returned product indicates that the expander could have been damaged during the implantation.The product insert data sheet cautions not to allow cautery devices or sharp instruments, such as scalpels, suture needles, hypodermic needles, hemostats, adson forceps, or scissors to contact the device during the implantation.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.No corrective and preventive action (capa) is required now.Additional complaint information monitoring for potential safety signals is 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: gabriel alfageme ; 3041 skyway circle north; irving, TX 75038 ; 9497898687
• MDR Report Key: 11118565
• Report Number: 1645337-2021-00071
• Device Sequence Number: 3698314
• Product Code: LCJ
• UDI-Device Identifier: 00081317002413
• UDI-Public: (01)00081317002413(17)240817(10)9481559
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K842883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/17/2024
• Device Model Number: 3504305M
• Device Catalogue Number: 3504305M
• Device Lot Number: 9481559
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/16/2020
• Supplement Date Received by Manufacturer: 10/24/2024
• Initial Report FDA Received Date: 01/05/2021
• Supplement Report FDA Received Date: 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2020
• 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
• Patient Sex: Unknown