MAUDE Adverse Event Report: MENTOR TEXAS MENTOR CE MED HEIGHT TE 450CC; EXPANDER, SKIN, INFLATABLE

Catalog Number 3548223

Device Problems Material Rupture (1546); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/07/2021

Event Type  malfunction  

Event Description

A mentor ce med height te 450cc tissue expander was received by the mentor failure analysis lab on december 30, 2021 with information that the device was explanted on (b)(6) 2021.The device could not be associated with an existing complaint.In the absence of clarifying information, it cannot be determined why this device was returned to mentor.However, the return of explanted devices is characteristic of a removal and replacement surgery.As a result, this will be conservatively reported to fda.

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.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: unknown.Manufacturer¿s reference number: (b)(4).

Manufacturer Narrative

On (b)(6) 2022, mentor became aware of the following information and corresponding fields have been updated on this form: - updated patient identifier under field a1 has been updated from "ni" to "s.L." - is product problem" has been selected under field b1 - the procedure type was "breast reconstruction primary" - updated date of event under field b3 to "(b)(6) 2021" - the issue occurred "intra-operatively" - removed date of explant from field d6b since issue was observed during surgery and tissue expander was immediately removed - type of reportable event under section h; field h1 has been updated from "serious injury" to "malfunction" - codes were updated under section h; - removed codes "device explantation", "no information available" and replaced them with "no patient consequence", "no adverse event" per issue was observed during surgery and tissue expander was immediately removed - updated medical device problem code to "material rupture" as deflation was noticed by the surgeon during procedure per information received.Manufacturer¿s reference number: (b)(4).

Manufacturer Narrative

On (b)(6) 2022, mentor became aware that medical device problem code for the user error was mistakenly not added under the previous initial submission.The code has been updated on this form.Manufacturer¿s reference number: (b)(4).H6 medical device problem code.

Manufacturer Narrative

On march 28, 2022, medical device problem code "use of device problem" (a23) has been added to more accurately capture the event.On march 30, 2022, the product investigation was completed.Device investigation summary: the product was returned to mentor for evaluation.Mentor then conducted a visual inspection, leak testing, and microscopic examination of the returned device.Visual analysis of the returned sample determined that the shell of the ce med height te 450cc tissue expander was found to be colored blue.Leak testing was performed, according to the mentor procedure, and it revealed a tear on the anterior view, measuring approximately 0.1 cm.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 tissue expander could have been damaged during the 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.As stated in the product insert data sheet, is contraindicated to place drugs or substances inside the tissue expander other than sterile saline for injection since this could compromise the product integrity.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.

• Brand Name: MENTOR CE MED HEIGHT TE 450CC
• Type of Device: 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: 13151741
• MDR Text Key: 283152069
• Report Number: 1645337-2022-00046
• Device Sequence Number: 1
• Product Code: LCJ
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/29/2022
• Device Catalogue Number: 3548223
• Device Lot Number: 7573606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female