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)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
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: unknown side deflation.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a female patient underwent unspecified breast surgery with a 400cc mentor tissue expander and experienced unknown side deflation.As a result, the device was explanted, and replaced with catalog number 3545295, and lot number 9417386 on an unknown date.
Additional Manufacturer Narrative
On 6/22/2021, mentor became aware that medical device problem code off-label use (a2304) was missing from the initial submission.Per the instructions for use, these devices are not indicated for breast tissue expansion applications.Manufacturer's reference number: (b)(4).Medical device problem code a2304 added to section h6.
Additional Manufacturer Narrative
On (b)(6) 2021, the mentor failure analysis lab 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
On (b)(6) 2021, expander evaluation was completed.Expander evaluation summary: mentor conducted visual inspections, leak testing and microscopic examinations.Visual analysis of the returned sample revealed that the exp rnd remote 400cc tissue expander was found to have two tears in the posterior view, measuring both tears approximately 0.5 cm.Leak testing was performed in accordance with mentor procedures and no additional leaks were detected.Microscopic examination was performed and the cause of the tear could not be identified.As the authorization form for examination was not received, the product evaluation lab could not identify a conclusion due to the specific nature of this deflation.The evaluation was limited to non-destructive testing.A manufacturing record evaluation was performed for the finished device lot number 9443035 and no non-conformances were identified.As indicated in the product insert data sheet, tissue expanders (radovan) are not intended to be used in breast-related procedures.As part of mentor¿s quality process all devices are manufactured, inspected, and released to approved specifications.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
After additional review of this event by mentor's clinical safety and regulatory teams on 22-jul-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.Manufacturer's reference number: (b)(4).H6 medical device problem code off-label use no longer applies.

• 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: 11244226
• Report Number: 1645337-2021-00810
• Device Sequence Number: 19725593
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 01/05/2021

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: 05/30/2024
• Device Model Number: 3504305M
• Device Catalogue Number: 3504305M
• Device Lot Number: 9443035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2021
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 01/05/2021
• Supplement Date Received by Manufacturer: 06/22/2021; 09/23/2021; 10/26/2021; 07/22/2022
• Initial Report FDA Received Date: 01/28/2021
• Supplement Report FDA Received Date: 07/15/2021; 10/04/2021; 10/26/2021; 08/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2020
• 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