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

Catalog Number	3549316
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The mentor failure analysis lab has received the device for evaluation.The analysis has begun, but is not complete at this time.When the investigational analysis has been completed, a supplemental report will be submitted.The device history record (dhr) was reviewed, 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 mentor cpx 4 breast tissue expander with suture tabs 750cc had a hole when the box was opened.The hole was discovered pre-operation so there was no patient contact.
Additional Manufacturer Narrative
It was reported that a mentor cpx 4 breast tissue expander with suture tabs 750cc had a hole when the box was opened.The hole was discovered pre-operation so there was no patient contact.The device was returned to mentor without fluid inside.No foreign material was observed within the device or on the shell surface.The mentor product analysis lab discovered a rent measuring approximately 2.4 cm on the posterior aspect.Microscopic examination of the edges of the rent revealed parallel striations.No other anomalies were discovered.The complaint was confirmed since a rupture was found in the device.Microscopic examination revealed parallel striations.This type of striations is more conclusive to sharp instrument damage rather than shell failure due to wear.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.(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: 8028892
• Report Number: 1645337-2018-06562
• Device Sequence Number: 1093553
• Product Code: LCJ
• UDI-Device Identifier: 00081317006824
• UDI-Public: 00081317006824
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/23/2022
• Device Catalogue Number: 3549316
• Device Lot Number: 7565808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2018
• Initial Date Received by Manufacturer: 10/04/2018
• Supplement Date Received by Manufacturer: 11/05/2018
• Initial Report FDA Received Date: 11/01/2018
• Supplement Report FDA Received Date: 11/26/2018
• Patient Sequence Number: 1