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

Catalog Number	3549214
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the time of this report, mentor has received no information regarding explantation or an expected explantation date.It is unknown at this time if the device will be made available for return.As a result, 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.Since no lot number was provided, no manufacturing record evaluation review could be performed.Reason for device explant and/or reoperation: n/a.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a female patient who underwent breast reconstruction revision with a 650cc mentor cpx 4 breast tissue expander with suture tabs experienced deflation of a tissue expander post procedure.As a result, the patient had to have the device removed and replaced with the permanent device prior to the date originally planned.
Additional Manufacturer Narrative
The investigation of the returned device was completed by the failure analysis lab on 12/13/2019.Device evaluation summary: according to the reported information, the patient experienced a deflation.A manufacturing record evaluation (mre) was performed for the finished device number 7603212, and no non-conformances related to the reported complaint condition were identified.During visual analysis of the device a rupture measuring approximately 0.1 cm was noted on the anterior view.During the microscope examination striations were detected on the edges of the rupture.No other anomalies were observed.The striations are consistent with markings made by a sharp instrument perforating silicone material.As stated in the product insert data sheet, do 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 this can result in rupture.It should be noted that as part of our quality process, each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.Based on the information reported and/or the product investigation, there is no evidence that the issue is related with the manufacturing process.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
The mentor failure analysis lab received the device for evaluation on 10/22/2019.The analysis has begun but is not complete at this time.When the investigation and analysis have been completed, a supplemental report will be submitted.The identity of the impacted product was updated based on the device received.Model number has been updated.The impacted product was a 550cc mentor cpx 4 breast tissue expander with suture tabs.On (b)(4) 2019 mentor became aware that the explant date was erroneously omitted from the initial report submitted on 10/22/2019.The explant date was (b)(6) 2019.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
• MDR Report Key: 9218412
• Report Number: 1645337-2019-22266
• Device Sequence Number: 2801981
• Product Code: LCJ
• UDI-Device Identifier: 00081317006817
• UDI-Public: 00081317006817
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/23/2019

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: 07/20/2022
• Device Catalogue Number: 3549214
• Device Lot Number: 7603212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2019
• Initial Date Received by Manufacturer: 09/23/2019
• Supplement Date Received by Manufacturer: 10/22/2019; 12/13/2019
• Initial Report FDA Received Date: 10/22/2019
• Supplement Report FDA Received Date: 11/19/2019; 12/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention