MAUDE Adverse Event Report: MENTOR TEXAS MED HEIGHT TE W/SUT TABS 350CC; EXPANDER, SKIN, INFLATABLE

Model Number	3549212
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	12/01/2021
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: deflation.Devices' image evaluation completed on (b)(6) 2022: upon visual evaluation of the image provided in the complaint, only one leak site was observed on the tissue expander.As the product involved in this complaint was not received, the device couldn´t be analyzed according to our procedures.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a female who underwent an unspecified breast augmentation with mentor cpx 4 breast tissue expander with suture tabs, 350cc.Implant experienced unknown-sided deflation post procedure.The report indicated that the leaking was happened, due to two torn parts between 'expander buffer zone' and 'edge of the shell.' it was observed 2 months (approximately) after the first implantation.The physical examination diagnosed the issue.As a result, on (b)(6) 2022, the existing artificial breast implant was removed, and a new product was inserted.Successfully completed the reoperation.
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.Devices' image evaluation completed on january 11 , 2022: upon visual evaluation of the image provided in the complaint, only one leak site was observed on the tissue expander.As the product involved in this complaint was not received, the device couldn´t be analyzed according to our procedures.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a female who underwent an unspecified breast augmentation with mentor cpx 4 breast tissue expander with suture tabs, 350cc.Implant experienced unknown-sided deflation post procedure.The report indicated that the leaking was happened, due to two torn parts between 'expander buffer zone' and 'edge of the shell.' it was observed 2 months (approximately) after the first implantation.The physical examination diagnosed the issue.As a result, on (b)(6) 2022, the existing artificial breast implant was removed, and a new product was inserted.Successfully completed the reoperation.
Additional Manufacturer Narrative
Additional information received on february 7, 2022 indicated that date of implantation was on (b)(6) 2021.Patients' left side was affected.The procedure status was reconstruction revision.The device was replaced with cat#: 3507320mc, sn#: (b)(6).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.Date of event updated to (b)(6) 2021.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Updated devices' photo evaluation completed on feb 28 , 2022: upon visual evaluation of the image provided in the complaint, only one leak site was observed on the tissue expander.As the product involved in this complaint was not received, the device couldn´t be analyzed according to our procedures.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Surveillance.,according to the information received, the patient experienced deflation in the med height te w/sut tabs 350cc tissue expander.Device evaluation completed on march 16 , 2022: the product was returned to mentor for evaluation.Mentor 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 med height te w/sut tabs 350cc tissue expander.Leak testing was performed, in accordance with mentor procedures, and a tear was noted on the union between shell and patch on the anterior view.Microscopic examination was performed, and the cause of the tear could not be identified.Although no conclusion could be reach on the cause of the reported event, the instructions for use contain the following caution: causes of deflation of tissue expander 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.As part of mentor¿s quality process all devices are manufactured, inspected, and released to approved specifications.Manufacturer¿s reference number: (b)(4).

• Brand Name: MED HEIGHT TE W/SUT TABS 350CC
• 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: 13419128
• Report Number: 1645337-2022-01082
• Device Sequence Number: 4690811
• Product Code: LCJ
• UDI-Device Identifier: 00081317006725
• UDI-Public: 00081317006725
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,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 Expiration Date: 08/09/2024
• Device Model Number: 3549212
• Device Catalogue Number: 3549212
• Device Lot Number: 9488639
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/10/2022
• Supplement Date Received by Manufacturer: 02/07/2022; 02/17/2022; 02/28/2022
• Initial Report FDA Received Date: 02/01/2022
• Supplement Report FDA Received Date: 02/14/2022; 02/24/2022; 03/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2020
• 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 Sex: Female