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

Model Number	3504305M
Medical Device Problem Codes	Off-Label Use (1494); Material Rupture (1546); Use of Device Problem (1670)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report contains supplemental information for mentor asr reference number (b)(4).Device evaluation summary: upon receipt by mentor, the device contained no fluid and could not be weighed.Brown and white material was observed within the device.White material was observed on the shell surface.During visual examination, pe observed a rent measuring 1.2 cm at patch.A microscopic examination of the edges of the rent revealed parallel striations which are similar to markings made by a sharp instrument perforating silicone material.No other anomalies were observed.Mentor performs 100% inspection and testing of all devices prior to release, pe concluded that the rent occurred sometime subsequent to the removal of the device from its protective packaging.According to the information provided, it was reported by the patient that after completing chemotherapy and radiotherapy, she perceived loss of volume of the left breast implant.During visual examination, pe observed a rent measuring 1.2 cm at patch.A microscopic examination of the edges of the rent revealed parallel striations.No other anomalies were observed.The complaint was confirmed.Because mentor performs 100% inspection and testing of all devices prior to release, pe concluded that the rent occurred sometime subsequent to the removal of the device from its protective packaging.Because the risk of device deflation cannot be eliminated, mentor addresses this risk in the pids by stating that these devices should not be considered lifetime devices.A manufacturing record evaluation is in progress.Once completed, a supplemental report will be submitted.Reason for device explant and/or reoperation: deflation.(b)(4).
Event or Problem Description
This report contains supplemental information for mentor asr reference number (b)(4).It was reported that a (b)(6) year-old female underwent primary breast reconstruction with 400cc mentor tissue expanders and experienced deflation on the left side after chemotherapy and radiotherapy postoperatively.As a result, the patient underwent device removal on (b)(6) 2017.
Additional Manufacturer Narrative
On (b)(6) 2020, the product investigation was updated.Updated device investigation summary: upon receipt by mentor, the device contained no fluid and could not be weighed.Brown and white material was observed within the device.White material was observed on the shell surface.During visual examination, pe observed a rent measuring 1.2 cm at patch.A microscopic examination of the edges of the rent revealed parallel striations which are similar to markings made by a sharp instrument perforating silicone material.No other anomalies were observed.Mentor performs 100% inspection and testing of all devices prior to release, pe concluded that the rent occurred sometime subsequent to the removal of the device from its protective packaging.Based on the dates of implantation and explantation provided, it was noticed that the device was inside the patient for more than six months.Per mentor ifu, tissue expanders are intended for temporary subcutaneous or submuscular implantation and are not intended for use beyond six months.A root cause of the failure could not be determined.Because pe was unable to confirm any unusual failure mode, no corrective action will be taken at this time.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.According to the information provided, it was reported by the patient that after completing chemotherapy and radiotherapy, she perceived loss of volume of the left breast implant.During visual examination, pe observed a rent measuring 1.2 cm at patch.A microscopic examination of the edges of the rent revealed parallel striations.No other anomalies were observed.The complaint was confirmed.Because mentor performs 100% inspection and testing of all devices prior to release, pe concluded that the rent occurred sometime subsequent to the removal of the device from its protective packaging.Because the risk of device deflation cannot be eliminated, mentor addresses this risk in the pids by stating that these devices should not be considered lifetime devices.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
After additional review of this event by mentor's clinical safety and regulatory teams on (b)(6) 2022, it has determined that the device was not used off-label.As a result, medical device problem code off-label use no longer applies.The device was implanted longer than six months, which is not in accordance with our instructions for use.Therefore h6 medical device problem code a23/use of device problem has been added.Manufacturer's reference numberp (b)(4).Removed h6 medical device problem code off-label use, and added a23/use of device problem.

• 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: 10721872
• Report Number: 1645337-2020-13515
• Device Sequence Number: 16955427
• Product Code: LCJ
• UDI-Device Identifier: 00081317002413
• UDI-Public: 00081317002413
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K842883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/23/2020

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: 11/24/2019
• Device Model Number: 3504305M
• Device Catalogue Number: 3504305M
• Device Lot Number: 6995018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2017
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/23/2020
• Supplement Date Received by Manufacturer: 11/10/2020; 07/22/2022
• Initial Report FDA Received Date: 10/22/2020
• Supplement Report FDA Received Date: 11/11/2020; 08/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/03/2015
• 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: 43 YR
• Patient Sex: Female