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

Model Number	3504302M
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2020
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: n/a.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a 250cc rectangular mentor tissue expander being used in a reconstruction surgery was found to be deflated intra-operatively.There were no reports of procedural delay or patient complications.If additional information is received, a supplemental report will be submitted as applicable.
Additional Manufacturer Narrative
Mentor received additional event information that the patient had experienced the implant deflation postoperatively, and on (b)(6) 2021 the patient required a secondary procedure due to the deflation malfunction.As a result, the patient underwent explantation and replacement with a new unspecified device.Reason for device explant and/or reoperation: deflation.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
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.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
The mentor failure analysis lab has completed the evaluation of the suspect medical device.Device evaluation summary: the product was returned to mentor for evaluation.Mentor then conducted a visual inspection, leak test, and microscopic examination of the returned device.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the exp rect remote, 250cc tissue expander.Leak testing was performed in accordance with mentor procedures, and a tear was noted in the posterior view, measuring approximately 0.1 cm.Additionally, the shell looks blue.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 implant shell.Based on the information currently available, microscopic examination of the returned product indicates that the implant could have been damaged during 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.Regarding the blue shell, multiple attempts have been made to obtain a clarification of the color of the shell.However, no additional information has been provided.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.A manufacturing record evaluation (mre) was performed for the finished device number 9354234, and no non-conformances related to the reported complaint were identified.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 28-feb-2022, it was found that the incorrect procedure was stated in b.5.On the initial report.Manufacturer's reference number: (b)(4) on the initial report, it was stated that the patient underwent a reconstruction surgery.However, the procedure that the patient underwent was a reconstructive skin surgery.

• 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 ; 9497898687
• MDR Report Key: 11564023
• Report Number: 1645337-2021-03106
• Device Sequence Number: 4781691
• Product Code: LCJ
• UDI-Device Identifier: 00081317002383
• UDI-Public: 00081317002383
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K842883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 02/26/2021

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: 09/22/2023
• Device Model Number: 3504302M
• Device Catalogue Number: 3504302M
• Device Lot Number: 9354234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2021
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 02/26/2021
• Supplement Date Received by Manufacturer: 04/01/2021; 05/26/2021; 05/26/2021; 02/28/2022
• Initial Report FDA Received Date: 03/24/2021
• Supplement Report FDA Received Date: 04/26/2021; 05/26/2021; 05/26/2021; 03/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2019
• 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: Unknown