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

Model Number	3504302M
Medical Device Problem Codes	Off-Label Use (1494); Material Rupture (1546); Use of Device Problem (1670)
Health Effect - Clinical Codes	No Code Available (3191); Insufficient Information (4580)
Date of Event	01/03/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).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.Since no lot number was provided, no device history record (dhr) review could be performed.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) female patient who underwent breast reconstruction revision with a 250cc mentor tissue expander, experienced left side deflation post-operatively.As a result, the patient underwent removal on (b)(6) 2019.
Additional Manufacturer Narrative
On (b)(6) 2019, the mentor failure analysis lab has received the device for evaluation.On (b)(6) 2019, the product investigation was completed.Device investigation summary: during evaluation of the device it appeared intact.Leak testing revealed there was a tear measuring approximately 0.1 cm, located at the posterior view.No additional anomalies were discovered.Microscopic examination was performed.No evidence of instrument damage was observed.The manufacturing records were reviewed, and the manufacturing criteria were met prior to the release of this lot.It should be noted that as part of our quality process, each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.Based on the information reported and/or the product investigation, there is no evidence that the issue is related with the manufacturing process.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On october 20, 2020, the product investigation summary was updated with the following statement: it was noticed that the device remained implanted for more than 6 months.In 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.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
After secondary review of this file performed on (b)(6) 2020, it was decided to add device code 1494 (off-label use), to more accurately capture the reported event.Per mentor's ifu for tissue expanders, these devices are not intended for use beyond six months.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Upon review, mentor has determined that there is no evidence that this device was used in a breast tissue expansion procedure as initially reported.There is currently no information regarding the type of procedure.Manufacturer¿s reference number: (b)(4), specified in h10 that the device is not confirmed to have been used in a breast tissue expansion application as initially reported.
Additional Manufacturer Narrative
Correction: an incorrect patient code (3191 ¿ no code available) was used for this event.The correct code has been added.Manufacturer¿s reference number: (b)(4).H6 health effect - clinical code: e2401 "insufficient information".
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.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 number: (b)(4) h6: medical device problem code off-label use was replaced with 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: 8392589
• Report Number: 1645337-2019-09011
• Device Sequence Number: 1576329
• Product Code: LCJ
• UDI-Device Identifier: 00081317002383
• UDI-Public: 00081317002383
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K842883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 02/06/2019

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 Model Number: 3504302M
• Device Catalogue Number: 3504302M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2019
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 02/06/2019
• Supplement Date Received by Manufacturer: 07/22/2019; 09/23/2020; 10/20/2020; 07/16/2021; 07/28/2021; 07/22/2022
• Initial Report FDA Received Date: 03/05/2019
• Supplement Report FDA Received Date: 08/01/2019; 10/08/2020; 11/05/2020; 07/16/2021; 08/05/2021; 08/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 34 YR
• Patient Sex: Female