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

Catalog Number	3549112
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/26/2019
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.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).
Event or Problem Description
It was reported that a (b)(6) caucasian female who underwent primary breast reconstruction with a 350cc mentor cpx 4 breast tissue expander with suture tabs experienced spontaneous left sided deflation post procedure.The deflation was confirmed by a physician.As a result, bilateral prosthesis replacement with 495cc mentor memoryshape breast implants was performed.
Additional Manufacturer Narrative
The investigation of the returned device was completed by the failure analysis lab on 9/24/2019.Device evaluation summary: according to the reported information, the patient experienced a deflation of the tissue expander.During initial evaluation of the sample it was observed to be intact.Leak testing revealed there was a tear measuring approximately 0.3 cm on the posterior view.Microscopic examination was performed and no evidence of instrument damage was observed.No additional anomalies were observed.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.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: 9082951
• Report Number: 1645337-2019-19602
• Device Sequence Number: 2614782
• Product Code: LCJ
• UDI-Device Identifier: 00081317006664
• UDI-Public: 00081317006664
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2019

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: 04/20/2022
• Device Catalogue Number: 3549112
• Device Lot Number: 7575175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2019
• Initial Date Received by Manufacturer: 08/20/2019
• Supplement Date Received by Manufacturer: 09/24/2019
• Initial Report FDA Received Date: 09/18/2019
• Supplement Report FDA Received Date: 10/17/2019
• 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
• Patient Age: 44 YR