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

Model Number	3549214
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	02/24/2023
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.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: deflation.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a female patient underwent a breast augmentation surgery with implantation of a 550cc mentor cpx 4 breast tissue expander with suture tabs.Post-operatively, the patient was diagnosed with a deflated left breast tissue expander by a medical professional.As a result, the patient underwent removal on an undisclosed date.The date of implantation was not provided to mentor.Several follow-ups have been conducted, and no additional information has been received.If more information becomes available, mentor will submit a supplemental report accordingly.
Additional Manufacturer Narrative
On september 13, 2023, mentor completed an evaluation on the returned device.The 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.Leak testing was performed, in accordance with mentor procedures, and a tear at the union between the shell and posterior patch.A microscopic examination was performed, and the cause of the tear could not be identified.Based on the current information, a product issue was identified during the investigation of the sample received.This product issue will be addressed through mentor¿s quality system.According to the manufacturing investigation, during the final inspection of the device, the lot was inspected for identifying any potential rupture/tear from the base to shell assembly, and no issues were found during the inspection, with consideration to the process controls, the evaluation performed by the analyst, and data records reviewed for the complaint device, the tear/rupture reported on the base to shell assembly is not able to be confirmed as a manufacturing defect.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On april 11, 2023, mentor completed an evaluation on an image that was provided of the suspect medical device.Upon visual evaluation of the image provided in the complaint, the device was observed deflated.However, the exact location of the rupture could not be observed in the image provided.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On june 02, 2023, 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.Paperwork received with the device provided the following information: a patient identifier was provided and the appropriate field has been populated.The complaint device was implanted during a breast reconstruction revision surgery.Date of implantation: (b)(6) 2022.Date of explantation: (b)(6) 2023.The patient underwent unilateral removal and replacement with a left-sided 550cc mentor cpx 4 breast tissue expander with suture tabs.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: 16695521
• Report Number: 1645337-2023-04083
• Device Sequence Number: 5616990
• Product Code: LCJ
• UDI-Device Identifier: 00081317006749
• UDI-Public: 00081317006749
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K130813
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• 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: 12/27/2025
• Device Model Number: 3549214
• Device Catalogue Number: 3549214
• Device Lot Number: 9673041
• 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: 03/16/2023
• Supplement Date Received by Manufacturer: 04/11/2023; 06/02/2023; 09/13/2023
• Initial Report FDA Received Date: 04/06/2023
• Supplement Report FDA Received Date: 04/12/2023; 06/15/2023; 09/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2021
• 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