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

Model Number	SCPX132TH
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
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.Since no lot number was provided, no manufacturing record evaluation could be performed.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.Reason for device explant and/or reoperation: deflation.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that female patient underwent an unspecified breast implantation with unspecified mentor tissue expanders and experienced deflation (side unknown) post-operatively.Information received indicates the patient underwent removal of the device, but the exact date of explantation is unknown.
Additional Manufacturer Narrative
On sep 23, 2022, additional information was received indicating the device lot number is 9698862, catalog number scpx132th.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.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On oct 5, 2022, the mentor failure analysis lab 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.Additional information was received with the device indicating the date of explantation was (b)(6) 2022.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Device evaluation summary: during the visual evaluation of the tissue expander, the tear was not identified.As a result, leak testing was performed in accordance with mentor procedures, and a tear was identified at the 3 o¿clock position.When evaluated under a microscope the tear pattern did not reveal parallel striations consistent with markings made by a sharp instrument.As the authorization form for examination was not received the evaluation was limited to non-destructive testing.Based on the current information, a product issue was identified during the investigation of the sample received.This product issue will be addressed through mentor¿s quality system.Manufacturing investigation was performed, and the process controls and data records collected are within specification.For the suspect tear in the expander for the lot number reported, this complaint is not able to be confirmed as a manufacturing defect.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR CPX4 PLUS, SMOOTH, TALL 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: michelleann garcia ; 3041 skyway circle north; irving, TX 75038 ; 646591-7981
• MDR Report Key: 15381255
• Report Number: 1645337-2022-10540
• Device Sequence Number: 5796952
• Product Code: LCJ
• UDI-Device Identifier: 10081317028441
• UDI-Public: 10081317028441
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K182335
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2026
• Device Model Number: SCPX132TH
• Device Catalogue Number: SCPX132TH
• Device Lot Number: 9698862
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/10/2022
• Supplement Date Received by Manufacturer: 09/23/2022; 10/05/2022; 02/14/2023
• Initial Report FDA Received Date: 09/08/2022
• Supplement Report FDA Received Date: 10/04/2022; 10/28/2022; 02/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2022
• 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 Sex: Female