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

Catalog Number	3549215
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/01/2019
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.Since no lot number was provided, no manufacturing record evaluation could be performed.Reason for device explant and/or reoperation: material rupture.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a female patient underwent primary breast reconstruction with a mentor cpx 4 breast tissue expander with suture tabs 650cc tissue expander and experienced deflation post procedure.The expander would not fill.As a result, the device was replaced with another tissue expander on (b)(6) 2019.
Additional Manufacturer Narrative
The mentor failure analysis lab received the device for evaluation on 7/12/2019.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 device returned had the lot number engraved.Lot number 7623513 has been added.D4 has been updated.A manufacturing record evaluation was performed for the finished device (b)(4) number, and no non-conformances related to the reported complaint condition were identified.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
The investigation of the returned device was completed by the failure analysis lab on 8/8/2019.Device evaluation summary: according to the reported information, the patient experienced a deflation of the tissue expander.The analysis results showed that the device appeared intact.Leak test revealed a tear on the anterior view measuring approximately 0.1 cm.No other anomalies were observed.Since the authorization for return and examination of medical device form was not signed and/or returned, mentor product analysis lab was precluded from further evaluating the device.Possible causes of deflation of tissue expander implants 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.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 WITH SUTURE TABS
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 8537089
• Report Number: 1645337-2019-10431
• Device Sequence Number: 19268427
• Product Code: LCJ
• UDI-Device Identifier: 00081317006756
• UDI-Public: 00081317006756
• 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,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/26/2019

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: 09/06/2022
• Device Catalogue Number: 3549215
• Device Lot Number: 7623513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2019
• Initial Date Received by Manufacturer: 03/26/2019
• Supplement Date Received by Manufacturer: 07/12/2019; 08/08/2019
• Initial Report FDA Received Date: 04/22/2019
• Supplement Report FDA Received Date: 08/06/2019; 08/09/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention