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

Model Number	3549317
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Seroma (2069); No Code Available (3191)
Date of Event	01/01/2017
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: right seroma (b)(4).Manufacturer¿s reference number: (b)(4).
Event or Problem Description
This event is associated with the athena clinical trial.It was reported that a (b)(6) year-old female patient who underwent breast reconstruction primary surgery with mentor athena study gel devices on (b)(6) 2017.Adverse event number 1.(b)(4) implant palpability/visibility, (right side, implant serial number: (b)(4).Date of implant: (b)(6) 2017, date of explant: (b)(6) 2017).On 05/15/2017, she presented with implant palpability/visibility, which required incision/drainage/aspiration and skin adjustment.The principal investigator assessed this event as severe in severity, non-serious, probably related to the device, and possibly related to the procedure.Adverse event number 2.(b)(4) seroma, (right side, implant serial number: (b)(4).Date of implant: (b)(6) 2017, date of explant: (b)(6) 2017).On (b)(6) 2017, she presented with seroma, which required unknown intervention.The principal investigator assessed this event as moderate in severity, non-serious, possibly related to the device, and possibly related to the procedure.Adverse event number 3.(b)(4) cellulitis, (right side, implant serial number: (b)(4).Date of implant: (b)(6) 2017, date of explant: (b)(6) 2017).On (b)(6) 2017, she presented with cellulitis, which required requires inpatient hospitalization with administration of unknown medication.The principal investigator assessed this event as severe in severity, serious, probably related to the device, and possibly related to the procedure.Adverse event number 4.(b)(4) delayed wound healing, (right side, implant serial number: (b)(4).Date of explant: (b)(6) 2017, doe: (b)(6) 2017).On (b)(6) 2017, she presented with delayed wound healing, which required skin adjustment on (b)(6) 2017 and (b)(6) 2017.The principal investigator assessed this event as moderate in severity, non-serious, not related to the device, and possibly related to the procedure.Adverse event number 5.(b)(4) implant palpability/visibility, (right side, implant serial number: (b)(4).(b)(4) date of implant: (b)(6) 2017, date of explant: (b)(6) 2017).On (b)(6) 2017, she presented with implant palpability/visibility, which required skin adjustment and device removal without replacement.The principal investigator assessed this event as moderate in severity, non-serious, possibly related to the device, and possibly related to the procedure.On (b)(6) 2017 she underwent flap reconstruction, capsulectomy and tissue expander insertion on right side.Brand and type of te is unknown.Adverse event number 6.(b)(4) early onset seroma on (b)(6) 2017 and (b)(6) 2017,(right side, tissue expander serial number: (b)(4).Date of implant: (b)(6) 2017, date of explant: (b)(6) 2017).On (b)(6) 2017, she presented with seroma, which required aspiration on (b)(6) 2017 and (b)(6) 2017.The principal investigator assessed this event as moderate in severity, non-serious, not related to the device, and not related to the procedure.Should more information become available, this note will be updated and case reassessed.This report is for adverse event #6 with the tissue expander.
Additional Manufacturer Narrative
On april 22, 2022, mentor became aware that the patient also experienced the following adverse event on the right side: adverse event # 7.Sepsis in 2019 right side, implant serial number: (b)(6) date of implant: (b)(6) 2017) in 2019, she presented with sepsis.No information was provided regarding treatment, medical or surgical procedure.The principal investigator assessed this event as severe in severity, serious, not related to the device, and not related to the procedure.Should more information become available, this note will be updated and case reassessed.This supplemental report is for adverse event #6 with the tissue expander.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
• Manufacturer (Section G): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• Manufacturer Contact: gabriel alfageme ; 3041 skyway circle north; irving, TX 75038 ; 949789-8687
• MDR Report Key: 10687481
• Report Number: 1645337-2020-13043
• Device Sequence Number: 2954948
• Product Code: LCJ
• UDI-Device Identifier: 00081317006831
• UDI-Public: 00081317006831
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K161176
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2020

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: 06/19/2020
• Device Model Number: 3549317
• Device Catalogue Number: 3549317
• Device Lot Number: 7341445
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/16/2020
• Supplement Date Received by Manufacturer: 04/22/2022
• Initial Report FDA Received Date: 10/15/2020
• Supplement Report FDA Received Date: 05/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/21/2016
• 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: 52 YR
• Patient Sex: Female
• Patient Weight: 109 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White