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

Model Number	3549313
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Capsular Contracture (1761)
Date of Event	07/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation summary: upon visual evaluation of the image provided in the complaint no apparent damage or visual anomalies were observed.Mentor concluded that the capsular contracture in the patient´s breast was the result of the body´s individual physiological response to the implantation of a foreign object in soft tissue.Capsular contracture is a known complication associated with these devices and is referenced in our current product insert data sheet.As part of mentor¿s quality process all devices are manufactured, inspected, and released to approved specifications.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: capsular contracture.Manufacturer's reference number: (b)(4).
Event or Problem Description
It was reported that a female patient underwent a breast surgery with a 450cc mentor cpx 4 breast tissue expander with suture tabs prosthesis and experienced postoperative left-sided grade iii capsular contracture.As a result, the patient underwent explanation on (b)(6) 2021.
Additional Manufacturer Narrative
On 23-sept-2021, mentor received additional information regarding the patient¿s information, procedure, diagnosis, revision surgery, suspected medical device.The patient identifier is (b)(6).The patient dob was estimated as (b)(6) 1967 based on available information.The patient underwent a revision breast reconstruction with the suspected medical device.The diagnosis of the capsular contracture was made based on ultrasonography.The patient underwent removal and replacement with a 450cc mentor cpx 4 breast tissue expander with suture tabs prosthesis (left catalog #: 3549313, left serial #: (b)(6)).The suspected medical device was returned for evaluation.On 10-oct-2021, the investigation on the suspected medical device was completed.Investigation summary: mentor conducted a visual inspection of the returned device.During visual evaluation, no apparent damage or visual anomalies were observed on the returned tissue expander.Mentor concluded that the capsular contracture in the patient¿s breast was the result of the body¿s individual physiological response to the implantation of a foreign object in soft tissue.Capsular contracture is a known complication associated with these devices and is referenced in our current product insert data sheet.As part of mentor¿s quality process all devices are manufactured, inspected, and released to approved specifications.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: 12356364
• Report Number: 1645337-2021-09445
• Device Sequence Number: 17137251
• Product Code: LCJ
• UDI-Device Identifier: 00081317006794
• UDI-Public: 00081317006794
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/10/2025
• Device Model Number: 3549313
• Device Catalogue Number: 3549313
• Device Lot Number: 9538177
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2021
• Initial Date Received by Manufacturer: 08/05/2021
• Supplement Date Received by Manufacturer: 09/23/2021
• Initial Report FDA Received Date: 08/23/2021
• Supplement Report FDA Received Date: 10/17/2021
• 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: 54 YR