MAUDE Adverse Event Report: MENTOR TEXAS MENTOR CPX4 WITH SUTURE TABS, MED HEIGHT, SMOOTH; CPX4 BREAST TISSUE EXPANDER WITH SMOOTH SURFACE

Catalog Number	3509214
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/18/2019
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) female patient underwent an unspecified procedure with a 550cc mentor cpx4 with suture tabs, med height, smooth breast tissue expander and experienced postoperative left-sided deflation.The diagnosis was confirmed by a physician.As a result, the patient underwent removal and replacement with a 550cc mentor cpx4 with suture tabs, med height, smooth ( catalog #:3509214, serial #:(b)(4)) on (b)(6) 2019.
Additional Manufacturer Narrative
On 9/18/19, the suspected medical device was returned for evaluation.On 10/04/19.The investigation on the suspected medical device was completed.Investigation summary : according to the reported information, the patient experienced a deflation in a tissue expander.The analysis results showed that the device appeared intact.Leak testing revealed there was a tear in one of the the suture tabs.Microscopic examination was performed for the reported deflation, and no evidence of device damage was observed.No other anomalies were observed.The manufacturing records were reviewed, and the manufacturing criteria were met prior to the release of this lot.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 the product investigation, no corrective action will be taken at this time.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.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR CPX4 WITH SUTURE TABS, MED HEIGHT, SMOOTH
• Common Device Name: CPX4 BREAST TISSUE EXPANDER WITH SMOOTH SURFACE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 8936982
• Report Number: 1645337-2019-17930
• Device Sequence Number: 19010967
• Product Code: LCJ
• UDI-Device Identifier: 00081317026679
• UDI-Public: 00081317026679
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K182335
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2019

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: 02/24/2023
• Device Catalogue Number: 3509214
• Device Lot Number: 7690032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2019
• Initial Date Received by Manufacturer: 08/13/2019
• Supplement Date Received by Manufacturer: 09/18/2019
• Initial Report FDA Received Date: 08/27/2019
• Supplement Report FDA Received Date: 10/11/2019
• 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: 43 YR