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

Catalog Number	3549314
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	07/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation summary: according to the information received, the patient experienced a deflation in the tissue expander.The investigation was completed on a photo of the suspect medical device because the physical device has not been received by mentor.Upon visual evaluation of the image provided in the complaint, the tissue expander was observed in a bag but no rent/puncture could be observed.As the product involved in this complaint was not received, 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.It should be noted that as part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Since no malfunction was observed during the investigation, 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.Reason for device explant and/or reoperation: tissue expander deflation.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 female patient underwent a breast augmentation procedure with a mentor cpx 4 breast tissue expander with suture tabs 550cc device that deflated post implantation.Deflation of the patient¿s left breast tissue expander was reported.As a result, the patient underwent explantation on an unknown date.
Additional Manufacturer Narrative
On 06-oct-2023, the mentor failure analysis lab 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.Additionally, mentor received additional information about the event: the patient identifier is (b)(6).The patient dob is (b)(6) 1983.It was previously reported that the patient underwent a breast augmentation procedure with the suspect medical device.New information received states that the patient underwent a breast reconstruction revision procedure with the suspect medical device.The explantation date is (b)(6) 2023.The patient¿s explanted left breast tissue expander was replaced with a mentor cpx 4 breast tissue expander with suture tabs 550cc device.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 08-jan-2024, mentor completed the investigation on the suspect medical device.Device evaluation summary: according to the information received, the patient experienced deflation in the tissue expander.The product was returned to mentor for evaluation.Mentor conducted a visual inspection, leak testing, and microscopic examination of the returned device.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 two tears (a and b) were noted on the anterior aspect measuring approximately 0.2 cm and 0.1 cm respectively.A microscopic examination was performed, and the cause of tear a could not be identified.In addition, a microscopic examination was performed on the edges of the tear b, 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 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.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances related to the issue reported were identified.Based on the information currently available, a microscopic examination of tear b indicates that the tissue expander could have been damaged during or subsequent to 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.According to the manufacturing investigation, the processes, equipment, or tools that could cause the tears in the shell were evaluated and were identified as a non-contributing factor for the tears found.The process controls and data records collected for the deflated tissue expander are within specification.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 will be conducted through complaint trending as part of post-market surveillance.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: 17638549
• Report Number: 1645337-2023-10076
• Device Sequence Number: 5970596
• Product Code: LCJ
• UDI-Device Identifier: 00081317006800
• UDI-Public: 00081317006800
• 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 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

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: 09/06/2025
• Device Catalogue Number: 3549314
• Device Lot Number: 9619946
• 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: Not provided
• Supplement Date Received by Manufacturer: 10/06/2023; 01/08/2024
• Initial Report FDA Received Date: 08/28/2023
• Supplement Report FDA Received Date: 10/20/2023; 01/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2021
• 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 Age: 40 YR
• Patient Sex: Female