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

Model Number	3549313
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	04/13/2021
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: deflation.Devices image evaluation completed on (b)(6) 2021: upon visual evaluation of the image provided in the complaint, the implant was observed within a plastic bag and no apparent damage could be observed.As the product involved in this complaint was not received, the device couldn´t be analyzed according to our procedures.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a female who underwent an unspecified breast surgery with a mentor cpx 4 breast tissue expander with suture tabs, 450cc implant experienced left-sided deflation post procedure.The issue was discovered through ultrasound examination.As a result, patient underwent replacement with cat#: 3549213 on (b)(6) 2021.
Additional Manufacturer Narrative
Devices image evaluation completed on december 23 , 2021:.Upon visual evaluation of the image provided in the complaint, the implant was observed within a plastic bag and no apparent damage 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.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Devices evaluation completed on december 28 , 2021:.The product was returned to mentor for evaluation.Mentor then conducted a visual inspection, leak test and microscopic examination of the returned device.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the tall height te wsut tabs 450cc tissue expander.Leak testing was performed in accordance with mentor procedures and a leak was identified in the anterior view of the tissue expander measuring approximately 0.1 cm in length.Microscopic examination was performed on the edges of the rupture, and parallel striations were found in the whole area of the leak site.Based on the information currently available, microscopic examination of the returned product indicates that the tissue expander could have been damaged during or subsequent to 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 implantation or other surgical procedures.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
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.Additional information received with the device indicated that the suspect device serial number is (b)(6), and replacement device is (b)(6).Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On october 26, 2021 mentor became aware that mistakenly missed reporting procedure type in initial report.Manufacturer¿s reference number: (b)(4).Breast augmentation revision.

• 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: gabriel alfageme ; 3041 skyway circle north; irving, TX 75038 ; 9497898687
• MDR Report Key: 12658892
• Report Number: 1645337-2021-11632
• Device Sequence Number: 4647740
• Product Code: LCJ
• UDI-Device Identifier: 00081317006794
• UDI-Public: 00081317006794
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2021
• 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
• Report Date (Section B): 09/27/2021

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: 01/28/2024
• Device Model Number: 3549313
• Device Catalogue Number: 3549313
• Device Lot Number: 9414362
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/27/2021
• Supplement Date Received by Manufacturer: 10/26/2021; 12/09/2021; 12/23/2021
• Initial Report FDA Received Date: 10/19/2021
• Supplement Report FDA Received Date: 11/19/2021; 12/16/2021; 12/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female