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

Model Number	3504303M
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation summary: according to the information received, the patient experienced deflation in the tissue expander.The investigation was completed on a photo of the suspect medical device because the physical device was not received by mentor.Upon visual evaluation of the image provided in the complaint, the tissue expander appears deflated.As the product involved in this complaint was not received, the device couldn't be analyzed according to our procedures.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.Reason for device explant and/or reoperation: tissue expander deflation.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent a reconstructive skin surgery procedure with a mentor tissue expander 400cc device that deflated after implantation.Damage to the device was verified with ultrasound.As a result, the patient underwent explantation on (b)(6) 2021.During explantation surgery, the surgeon noticed that there was a rupture on one of its edges.
Additional Manufacturer Narrative
On 18-nov-2021, the mentor failure analysis lab received the device for evaluation.On 06-dec-2021, mentor completed the investigation on the suspect medical device.Device evaluation summary: according to the information received, the patient experienced deflation in the tissue expander.The product was returned to mentor for evaluation.Mentor then conducted a visual inspection, microscopic examination and thickness measurement of the returned device.Visual analysis of the returned sample revealed that the device was found to have a tear at the juncture patch of the device.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 site, and the thickness was found to be within manufacturing specifications.A manufacturing record evaluation was performed for the finished device lot number: 7508570 and no non-conformances related to this complaint were 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 saline 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.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Manufacturer¿s reference number: (b)(4).

• 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: 12556195
• Report Number: 1645337-2021-10904
• Device Sequence Number: 4307254
• Product Code: LCJ
• UDI-Device Identifier: 00081317002390
• UDI-Public: 00081317002390
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K842883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2021

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: 09/24/2021
• Device Model Number: 3504303M
• Device Catalogue Number: 3504303M
• Device Lot Number: 7508570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/09/2021
• Supplement Date Received by Manufacturer: 11/18/2021
• Initial Report FDA Received Date: 09/30/2021
• Supplement Report FDA Received Date: 12/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2017
• 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 Sex: Unknown