MAUDE Adverse Event Report: MENTOR TEXAS MENTOR TISSUE EXPANDER; EXPANDER, SKIN, INFLATABLE

Model Number	3504311M
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Unspecified Infection (1930); Deformity/ Disfigurement (2360); No Code Available (3191); Insufficient Information (4580)
Date of Event	09/15/2020
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: infection, debris in the expander, deflation.(b)(4).Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old female patient underwent a reconstruction skin surgery with two 700cc mentor tissue expander prostheses and experienced bilateral deflation and wound infection postoperatively.On (b)(6) 2020, the patient was going through an expansion process for the expanders.However, the expansion process was not successful.Due to the failure of the expander expansion, ultrasound was performed by a radiologist, and the result indicated unspecified debris and infection fluid inside of both expanders.As a result, the patient underwent bilateral removal without replacement on (b)(6) 2020.Upon explantation, the devices were found to be damaged, and unspecified infected fluid and debris were again observed inside of both expanders.One of the expanders (side unknown) was found to be damaged at the junction of the base plate, while the other expander was found to be damaged at near the port.If additional information is received in the future, a supplemental report will be submitted.This report is for the right-sided prosthesis.
Additional Manufacturer Narrative
On 17-dec-2020, mentor received additional information regarding the complaint devices.The devices are not available for return.On 6-jan-2021, the analysis was completed based on a photo that was provided.On 7-jan-2021, mentor received additional information regarding the condition of the complaint device.Unspecified debris found inside of the device are broken pieces of the tissue expander.Investigation summary: upon visual evaluation of the image provided in the complaint, the tissue expander was observed to have a tear.As the product involved in this complaint was not received, the device couldn´t be analyzed according to our procedures.Infection, manifested by swelling, tenderness, pain and fever, may appear in the immediate postoperative period or at any time after insertion of the device.In the absence of classic symptoms, subacute or chronic infections may be difficult to diagnose.If infection does not subside promptly with the appropriate treatment, removal of the device is indicated.Infection is a known complication associated with any surgery.Per a database query, this is the only reported complaint of infection against this lot number.The mentor microbiology department has provided information on the sterility lot for the implanted device indicating that it met all sterilization parameters required to provide a 10e-6 sterility assurance level prior to release for distribution.Product evaluation concluded the reported infection occurred from a source other than the device.Infection is a known complication associated with any surgery and is referenced in our current product insert data sheet.Each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
On 1-feb-2021, mentor received additional information regarding the patient's symptoms and condition of the suspected medical device.The patient did not experience infection.In addition to what was reported previously, the patient's surgeon reported that fluid with some tissue was observed inside of the expander due to the deflation.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
On 18-jan-2021, mentor received additional information regarding the condition of the suspected medical device.In addition to broken pieces of the device, the patient's blood and body fluid were observed inside of the device and were reported as debris previously.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
On (b)(6) 2021, the product investigation was updated.The following statements regarding infections were removed from the investigation summary.¿infection, manifested by swelling, tenderness, pain and fever, may appear in the immediate postoperative period or at any time after insertion of the device.In the absence of classic symptoms, subacute or chronic infections may be difficult to diagnose.If infection does not subside promptly with the appropriate treatment, removal of the device is indicated.Infection is a known complication associated with any surgery.Per a database query, this is the only reported complaint of infection against this lot number.The mentor microbiology department has provided information on the sterility lot for the implanted device indicating that it met all sterilization parameters required to provide a 10e-6 sterility assurance level prior to release for distribution.Product evaluation concluded the reported infection occurred from a source other than the device.Infection is a known complication associated with any surgery and is referenced in our current product insert data sheet.¿ manufacturer's reference number (b)(4).
Additional Manufacturer Narrative
On (b)(6) 2021, upon review, it was determined that mentor did not receive specific patient consequence.Since there is no applicable patient consequence code (h.6.Health effect - clinical code), the coding was updated with insufficient information (e2401).The relevant field has been updated.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
On (b)(6) 2022, the product investigation summary was updated: upon visual evaluation of the image provided in the complaint, the tissue expander was observed to have a tear on the union between shell and patch.As the product involved in this complaint was not received, the device couldn´t be analyzed according to our procedures.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.

• Brand Name: MENTOR TISSUE EXPANDER
• 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: 10810134
• Report Number: 1645337-2020-14259
• Device Sequence Number: 19714336
• Product Code: LCJ
• UDI-Device Identifier: 00081317002475
• UDI-Public: 00081317002475
• Combination Product (Y/N): N
• Initial Reporter Country: PK
• PMA/510(K) Number: K842883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 10/12/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/01/2021
• Device Model Number: 3504311M
• Device Catalogue Number: 3504311M
• Device Lot Number: 7473021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 10/12/2020
• Supplement Date Received by Manufacturer: 12/17/2020; 01/18/2021; 02/01/2021; 02/23/2021; 07/28/2021; 10/25/2022
• Initial Report FDA Received Date: 11/09/2020
• Supplement Report FDA Received Date: 01/08/2021; 01/19/2021; 02/22/2021; 02/24/2021; 08/08/2021; 10/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/06/2017
• 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: 29 YR
• Patient Sex: Female