MAUDE Adverse Event Report: MENTOR TEXAS CPX4 PLUS SMOOTH MEDIUM HEIGHT 800CC; EXPANDER, SKIN, INFLATABLE

Model Number	SCPX156MH
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the time of this report, mentor has received no information regarding explantation or an expected explantation date.It is unknown at this time if the device will be made available for return.As a result, 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: n/a.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a female patient underwent a breast surgery with a 800cc cpx4 plus smooth medium heigh tissue expander and experienced postoperative right-sided deflation.The patient had a consultation with a healthcare professional.At the time of this report, mentor has received no information regarding an expected explantation date.
Additional Manufacturer Narrative
On (b)(6) 2021, it was found that the product return fields in section d were omitted on the previous report.On (b)(6) 2021, the investigation on the suspected medical device was completed.Investigation summary : mentor conducted a visual inspection and leak testing of the returned device.Visual analysis of the returned device revealed no damage or anomalies on the returned tissue expander.Leak testing was performed in accordance with mentor procedures, and no leak sites were detected during the analysis.The event described could not be confirmed as the tissue expander was returned without detectable damage.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Manufacturer's reference number: (b)(4) the relevant fields have been updated in section d.
Additional Manufacturer Narrative
On 20-apr-2021, mentor received addtional information regarding the suspected medical device and explantation date.The mentor failure analysis lab has 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.The explantation date was estimated as (b)(6) 2021 based on available information.Updated reason for device explant and/or reoperation: deflation.Manufacturer's reference number: (b)(4).

• Brand Name: CPX4 PLUS SMOOTH MEDIUM HEIGHT 800CC
• Common Device Name: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 11499011
• Report Number: 1645337-2021-02779
• Device Sequence Number: 2869332
• Product Code: LCJ
• UDI-Device Identifier: 10081317028403
• UDI-Public: 10081317028403
• 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 Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/19/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/19/2024
• Device Model Number: SCPX156MH
• Device Catalogue Number: SCPX156MH
• Device Lot Number: 9518641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• Initial Date Received by Manufacturer: 02/19/2021
• Supplement Date Received by Manufacturer: 04/20/2021; 05/16/2021
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 05/13/2021; 05/23/2021
• 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: Other; Required Intervention