MAUDE Adverse Event Report: MENTOR TEXAS MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS; EXPANDER, SKIN, INFLATABLE

Catalog Number	3549212
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2023
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.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.Reason for device explant and/or reoperation: n/a.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a 350cc mentor cpx 4 breast tissue expander with suture tabs was observed to have a material puncture during a breast reconstruction surgery prior to being implanted into the patient.No adverse events or patient consequences were reported.No further information was provided.The date of event was not provided to mentor.Follow-ups are being conducted.If more information becomes available, mentor will submit a supplemental report accordingly.
Additional Manufacturer Narrative
On january 16, 2024, the mentor analysis lab received the suspect medical device for evaluation.On january 24, 2024, mentor completed an evaluation on the returned device.Mentor conducted a visual inspection, leak testing, and microscopic examination of the tissue expander.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the tissue expander.In addition, the tissue looks blue.Leak testing was performed, in accordance with mentor procedures, and a tear was noted on the anterior aspect measuring approximately 0.4 cm.Microscopic examination was performed on the edges of the rupture, and parallel striations were found in the whole area of the tear.Parallel striations are consistent with markings made by a sharp object perforating the implant shell.Based on the information currently available, a microscopic examination of the returned product indicates that the tissue expander could have been damaged during implantation.The product insert data sheet cautions to not 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 or other surgical procedures.As per additional information received, the customer added sterile dimethylene blue to the sterile solution.As stated in the product insert data sheet, is contraindicated to place drugs or substances inside the tissue expanders other than sterile saline for injection since this could compromise the product integrity.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On september 18, 2023, mentor was provided with the following additional information.The date of event was august 18, 2023.Additionally, the surgery was completed using another tissue expander.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR CPX 4 BREAST TISSUE EXPANDER WITH SUTURE TABS
• 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: 17731507
• Report Number: 1645337-2023-10736
• Device Sequence Number: 6440453
• Product Code: LCJ
• UDI-Device Identifier: 00081317006725
• UDI-Public: 00081317006725
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K130813
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 3549212
• Device Lot Number: 9816783
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2023
• Supplement Date Received by Manufacturer: 09/18/2023; 01/16/2024
• Initial Report FDA Received Date: 09/12/2023
• Supplement Report FDA Received Date: 10/05/2023; 01/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2022
• 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