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

Catalog Number	3548313
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/01/2018
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 device history record review is in progress.Once completed, a supplemental report will be submitted.(b)(6).Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent breast reconstruction with a 450cc mentor cpx 4 breast tissue expander and experienced left sided deflation post procedure.The physician noted a rent at the juncture of the port and the interface.The patient had device replacement as a result.The patient was noted to have recovered physically from the event.
Additional Manufacturer Narrative
A manufacturing record evaluation (mre) was performed for the finished device number 7386476 on (b)(6) 2019, and no non-conformance's related to the reported complaint condition were identified.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
The mentor failure analysis lab received the device for evaluation on 4/22/2019.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.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
The investigation of the returned device was completed by the failure analysis lab on 7/11/2019.Device evaluation summary: according to the information provided, it was reported that the patient experienced a deflation of the mentor expander (cpx4 expander).During evaluation of the sample a tear was observed on the anterior view at the union between patch and shell of the implant.Since the authorization for return and examination of medical device form was not signed and/or returned, the mentor product analysis lab was precluded from further evaluating the device.No additional anomalies were observed.Possible causes of deflation of mentor tissue expanders include, but are not limited to the following events: excessive stresses or manipulations as may occur during normal, daily routines including customary and purposeful trauma to the breast.Mentor tissue expander implants are not considered lifetime devices and deflation is a known complication associated with these devices and is referenced in our product insert data sheet.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).

• Brand Name: MENTOR CPX 4 BREAST TISSUE EXPANDER
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 8376039
• Report Number: 1645337-2019-08913
• Device Sequence Number: 16701517
• Product Code: LCJ
• UDI-Device Identifier: 00081317006602
• UDI-Public: 00081317006602
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/29/2019

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: 10/16/2020
• Device Catalogue Number: 3548313
• Device Lot Number: 7386476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2019
• Initial Date Received by Manufacturer: 01/29/2019
• Supplement Date Received by Manufacturer: 03/02/2019; 04/22/2019; 07/11/2019
• Initial Report FDA Received Date: 02/27/2019
• Supplement Report FDA Received Date: 03/27/2019; 05/14/2019; 07/12/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention