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

Model Number	3504304M
Medical Device Problem Codes	Off-Label Use (1494); Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/10/2020
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.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a female patient underwent a primary breast reconstruction surgery with mentor tissue expander exp rnd remote 700cc implants which the left side deflated after implantation.As a result patient underwent bilateral mastectomy and immediate reconstruction with silicone implants on (b)(6) 2020.
Additional Manufacturer Narrative
Device evaluation summary; during visual inspection of the sample, a tear was found at the union between shell and patch.Microscopic examination was performed and the cause of the rupture could not be identified.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.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.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
Upon review, mentor has become 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 off-label use (a2304) added to h6 medical device problem code field.
Additional Manufacturer Narrative
Updated device evaluation completed on (b)(6) 2022: the product was returned to mentor for evaluation.Mentor conducted a visual inspection, microscopic examination and thickness measurement of the returned device.Visual analysis of the returned sample revealed that the exp rnd remote 700cc tissue expander was found to have a tear at the juncture between the shell and patch on the posterior view.A microscopic examination was performed and the cause of the deflation could not be identified.Therefore a thickness measurement was conducted on the shell at the tear, and the thickness was within manufacturing specifications.Although no conclusion could be reached on the cause of the reported event, 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.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
Updated device evaluation completed on (b)(6) 2021: visual analysis of the returned sample revealed that the exp rnd remote 700cc tissue expander was found to have a tear at the juncture between the shell and patch.A microscopic examination was performed and the cause of the deflation could not be 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 EXPANDERC
• 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: 9770007
• Report Number: 1645337-2020-03294
• Device Sequence Number: 14096868
• Product Code: LCJ
• UDI-Device Identifier: 00081317002406
• UDI-Public: 00081317002406
• Combination Product (Y/N): N
• PMA/510(K) Number: K842883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• 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,Followup,Followup
• Report Date (Section B): 02/05/2020

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: 10/22/2021
• Device Model Number: 3504304M
• Device Catalogue Number: 3504304M
• Device Lot Number: 7509206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2020
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 02/05/2020
• Supplement Date Received by Manufacturer: 03/12/2020; 04/06/2020; 07/15/2021; 09/29/2021; 07/22/2022; 08/14/2022
• Initial Report FDA Received Date: 02/28/2020
• Supplement Report FDA Received Date: 03/13/2020; 04/10/2020; 07/15/2021; 10/22/2021; 08/02/2022; 09/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2017
• 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: 47 YR
• Patient Sex: Female