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

Model Number	3549213
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	08/10/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a female who underwent a primary breast reconstruction with mentor cpx 4, breast tissue expander with suture tabs, 450cc experienced left-sided deflation post procedure.As a result, patient underwent replacement with cat#: 3549313, sn#: (b)(4) on (b)(6) 2021.
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.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.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Updated device evaluation completed on (b)(6) 2022: the product was returned to mentor for evaluation.Mentor 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 med height te w/sut tabs 450cc tissue expander.Leak testing was performed, in accordance with mentor procedures, and a tear was noted on the patch on the anterior view.A microscopic examination was performed, and the cause of the tear could not be identified.Although no conclusion could be reached on the cause of the reported event, the instructions for use contain the following caution: according to the product insert data sheet, it is possible to damage the tissue expander during insertion.Ensure that excessive force is not applied to a very small area of the shell during insertion of the device through the incision.Instead, apply force over as large an area of the tissue expander as possible.Avoid pushing the device into place with one or two fingers in a localized area, as this may create an area of weakness on the shell.In addition, an incision should be of appropriate length to accommodate the style, size, and profile of the tissue expander.This will reduce the potential for creating excessive stress to the tissue expander during insertion, and will avoid the risk of damage to the tissue expander.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Devices image evaluation completed on (b)(6) 2022: upon visual evaluation of the image provided in the complaint, no apparent damage or visual anomalies were observed.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
Device evaluation completed on (b)(6) 2022: the product was returned to mentor for evaluation.Mentor conducted a visual inspection and microscopic examination of the returned device.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the med height te w/sut tabs 450cc tissue expander.Leak testing was performed, in accordance with mentor procedures, and a tear was noted on the patch on the anterior view.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 tissue expander shell.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: gabriel alfageme ; 3041 skyway circle north; irving, TX 75038 ; 9497898687
• MDR Report Key: 12910818
• Report Number: 1645337-2021-13295
• Device Sequence Number: 4963105
• Product Code: LCJ
• UDI-Device Identifier: 00081317006732
• UDI-Public: 00081317006732
• 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: 2021
• 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): 11/07/2021

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: 08/06/2024
• Device Model Number: 3549213
• Device Catalogue Number: 3549213
• Device Lot Number: 9488623
• 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: 11/07/2021
• Supplement Date Received by Manufacturer: 12/09/2021; 01/06/2022; 01/17/2022
• Initial Report FDA Received Date: 12/01/2021
• Supplement Report FDA Received Date: 12/16/2021; 01/10/2022; 01/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2020
• 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