MAUDE Adverse Event Report: MENTOR TEXAS MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT; EXPANDER, SKIN, INFLATABLE

Catalog Number	SCPX127MH
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Local Reaction (2035); Seroma (2069)
Date of Event	10/01/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported (via medsun (b)(4)) that a patient underwent an ataxia-telangiectasis mutated (atm) mutation surgery for prophylactic bilateral mastectomy with mentor cpx4 plus, smooth, medium height 450cc tissue expanders presented with a large fluid collection on her right chest wall post implantation.Additionally, the patient developed necrosis on the mastectomy flap.As a result, the patient underwent explantation of the right breast tissue expander on an unknown date.On a later date, the patient presented with fluid on her left chest wall and underwent drainage of the fluid.The patient was admitted to the emergency department again and 11.7 cm fluid was detected with ultrasound.The patient underwent drainage of bilateral breast seromas and placement of 19 french drain on an unknown date.After healing, the patient underwent surgery for delayed insertion of a mentor cpx4 plus, smooth, medium height 450cc tissue expander in her right breast on an unknown date.The patient later developed pain and redness in her left breast on an unknown date.As a result of the above, the patient underwent bilateral removal of the tissue expanders on an unknown date.The patient presented at the emergency department again for pain at the jp drain site following explant surgery.A gram stain and anaerobic culture were obtained with no growth reported.This medwatch report is for the patient¿s left tissue expander.
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: seroma, pain and redness on breast.Mentor is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which mentor has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, mentor, or its employees that the report constitutes an admission that the device, mentor, or its employees caused or contributed to the potential event described in this report.If certain information is unknown, not available or does not apply, the section/field of the form is left blank.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Mentor became aware that five additional voluntary medwatch reports (mw5158322, mw5158321, mw5158586, mw5158733, mw5158734) were submitted to the fda regarding this event.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR CPX4 PLUS, SMOOTH, MEDIUM HEIGHT
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer (Section G): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer Contact: kate karberg ; 3041 skyway circle north; irving, TX 75038 ; 3035526892
• MDR Report Key: 20091119
• Report Number: 1645337-2024-10039
• Device Sequence Number: 7810469
• Product Code: LCJ
• UDI-Device Identifier: 10081317028373
• UDI-Public: (01)10081317028373(17)261218(10)9842709
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K182335
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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 Catalogue Number: SCPX127MH
• Device Lot Number: 9842709
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/30/2024
• Supplement Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 76 KG
• Patient Race: White