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

Catalog Number	3549114
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/07/2018
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.The device history record ( dhr) of lot number 6769865 reviewed on (b)(6) 2018 and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.(b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old female patient underwent primary breast reconstruction with a mentor cpx 4 breast tissue expander with suture tabs 220cc.Deflation on the left tissue expander was diagnosed post procedure.As a result, the patient underwent unilateral removal and replacement with a mentor memoryshape breast implant 480cc gel prosthesis on (b)(6) 2018.
Additional Manufacturer Narrative
The mentor failure analysis lab received the device for evaluation on 5/15/2018.Device evaluation summary: it was reported that a (b)(6) year-old female patient underwent primary breast reconstruction with a mentor cpx 4 breast tissue expander with suture tabs 220cc.Deflation on the left tissue expander was diagnosed post procedure.As a result, the patient underwent unilateral removal and replacement with a mentor memoryshape breast implant 480cc gel prosthesis on (b)(6) 2018.The device was received at mentor without fluid.No foreign material was observed within the device.No foreign material was observed on the shell surface.During examination, the product evaluation team observed a rent measuring approximately 0.5 cm on the posterior aspect.Microscopic examination of the edges of the rent gave no indications as to cause. no other anomalies were discovered. the complaint was confirmed since a rupture was found on the device.  breast 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.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: 7474698
• Report Number: 1645337-2018-02431
• Device Sequence Number: 18860449
• Product Code: LCJ
• UDI-Device Identifier: 00081317006688
• UDI-Public: 00081317006688
• 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: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2018

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: 10/31/2017
• Device Catalogue Number: 3549114
• Device Lot Number: 6769865
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2018
• Initial Date Received by Manufacturer: 04/04/2018
• Supplement Date Received by Manufacturer: 04/04/2018
• Initial Report FDA Received Date: 04/30/2018
• Supplement Report FDA Received Date: 05/30/2018
• 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: 39 YR