MAUDE Adverse Event Report: MENTOR TEXAS CPX4 PLUS SM TE MH 275CC; EXPANDER, SKIN, INFLATABLE

Catalog Number	SCPX107MH
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.Since no lot number was provided, no manufacturing record evaluation review 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: the patient has not undergone explantation or reoperation at this time.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent an unspecified breast surgery with an unspecified mentor breast tissue expander.Post-operatively, the patient experienced a deflation on an undisclosed side, which was confirmed by a medical professional.At the time of this report, mentor has no information regarding explantation or an expected explantation date.Follow-ups are being conducted.If more information becomes available, mentor will submit a supplemental report accordingly.
Additional Manufacturer Narrative
On june 28, 2024, mentor received additional information.The device was identified as a 275cc mentor cpx4 tissue expander.The following information was added to the device identity: brand name: mentor cpx4 plus, smooth, medium height size: 275cc lot: 9813604 catalog: scpx107mh d4: udi: as the serial number for the device involved in the event was not provided, the full udi is currently not available.A manufacturing record evaluation (mre) was performed for the provided lot number 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.The patient underwent removal surgery on an undisclosed date.Reason for device explant and/or reoperation: deflation on july 16, 2024, mentor received the device for evaluation as well as additional information.Date of explant was added as (b)(6) 2024.Patient identifier was added.The analysis of the returned device has begun but is not complete at this time.When the investigational analysis has been completed, a supplemental report will be submitted.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On july 18, 2024, mentor completed a visual inspection, leak test, and microscopic examination of the returned device.Device evaluation summary: visual analysis of the returned sample revealed that no damage or anomalies were observed on the returned device.Leak testing was performed, according to mentor procedure, and it identified a tear measuring approximately 0.1 cm on the anterior aspect.Microscopic examination was performed on the edges of the rupture, and parallel striations were found in the whole area of the tear.Parallel striations are consistent with markings made by a sharp object perforating the tissue expander shell.Based on the information currently available, microscopic examination of the returned product indicates that the device could have been damaged during or subsequent to implantation.The product insert data sheet cautions to not allow cautery devices or sharp instruments, such as scalpels, suture needles, hypodermic needles, hemostats, adson forceps or scissors to contact the device during the implantation or other surgical procedures.Manufacturer¿s reference number: (b)(4).

• Brand Name: CPX4 PLUS SM TE MH 275CC
• 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: 19520867
• Report Number: 1645337-2024-07084
• Device Sequence Number: 14960122
• Product Code: LCJ
• UDI-Device Identifier: 10081317028359
• UDI-Public: (01)10081317028359(11)221111(17)261025(10)9813604
• 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: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,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 Catalogue Number: SCPX107MH
• Device Lot Number: 9813604
• 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: 05/21/2024
• Supplement Date Received by Manufacturer: 06/28/2024; 07/18/2024
• Initial Report FDA Received Date: 06/12/2024
• Supplement Report FDA Received Date: 07/18/2024; 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2022
• 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; Other
• Patient Sex: Female