MAUDE Adverse Event Report: MENTOR TEXAS MED HEIGHT TE W/SUT TABS 550CC; EXPANDER, SKIN, INFLATABLE

Model Number	3549214
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	03/10/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a (b)(6) year-old caucasian female who underwent an unspecified breast reconstruction with a mentor cpx 4 breast tissue expander with suture tabs, 550cc breast implant experienced right-sided deflation post procedure.At the time of deflation device was filled up to 180cc.As a result, patient underwent unilateral replacement with cat#: 3549214, sn#:(b)(4) on (b)(6) 2022.
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: deflation manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Suspect device received on april 05, 2022.Device evaluation completed on april 22 , 2022: the product was returned to mentor for evaluation.Mentor then conducted a visual inspection, leak testing, and microscopic examination of the returned device.During the visual analysis of the returned sample med height te w/sut tabs 550cc no apparent damage or visual anomalies were observed.Leak testing was performed, according to the mentor procedure, and it revealed two tears (a and b) on the anterior view, measuring approximately 0.1 cm and 0.2 cm respectively.Microscopic examination was performed on the edges of the ruptures (a and b), and parallel striations were found in the whole area of the tear (a).Parallel striations are consistent with markings made by a sharp object perforating the tissue expander shell.Related to the rupture (b), the cause of the tear (b) could not be identified.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Based on the information currently available, microscopic examination of the rupture (a) indicates that the tissue expander 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.Although no conclusion could be reached on the cause of the rupture (b), the instructions for use contain the following caution: causes of deflation of tissue expanders include but are not limited to the following events: crease fold failure, intraoperative or postoperative trauma, excessive stresses or manipulations as may occur during normal, daily routines including customary and purposeful trauma such as that which can occur during vigorous exercise, athletics, etc.According to the date of implantation and explantation, it was noticed that the device remained implanted for more than 6 months.Per mentor instructions for use (ifu), tissue expanders are not intended for implantation beyond 6 months.Therefore, this device was used in an off-label manner.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.The suspect device lot # updated to 9490041, due to receive of the device with this identity.Manufacturer¿s reference number: (b)(4).

• Brand Name: MED HEIGHT TE W/SUT TABS 550CC
• 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: 13826130
• Report Number: 1645337-2022-02996
• Device Sequence Number: 17259883
• Product Code: LCJ
• UDI-Device Identifier: 00081317006749
• UDI-Public: 00081317006749
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K130813
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,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 Expiration Date: 08/16/2024
• Device Model Number: 3549214
• Device Catalogue Number: 3549214
• Device Lot Number: 9490041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/24/2022
• Supplement Date Received by Manufacturer: 04/05/2022
• Initial Report FDA Received Date: 03/19/2022
• Supplement Report FDA Received Date: 04/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2020
• 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: 58 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White