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

Model Number	3504315M
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Deformity/ Disfigurement (2360); Insufficient Information (4580)
Date of Event	01/29/2021
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.Since no lot number was provided, no manufacturing record evaluation could be performed.Reason for device explant and/or reoperation: deflation.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old female patient underwent a breast surgery with a 300cc mentor tissue expander and experienced postoperative right-sided deflation.The diagnosis was confirmed by a healthcare professional.As a result, the patient underwent removal and replacement with an unspecified tissue expander on (b)(6) 2021.
Additional Manufacturer Narrative
On (b)(6) 2021, the product investigation was updated.Investigation summary: mentor conducted microscopic examination, and thickness measurement of the returned device.Microscopic examination was performed on the edges of tear b.Tear b did not show striations, therefore a thickness measurement was conducted on the shell at the tear, and the thickness was within manufacturing specifications.Based on the information currently available, microscopic examination of the returned product indicates that the implant could have being damaged during or subsequent to implantation.The product insert data sheet cautions to not allow cautery devices or sharp instruments, such as scalpels, suture needles, hypodermic needles, hemostats, adson forceps or scissors to contact the device during the implantation or other surgical procedures.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
Upon review of this event, mentor has become aware that the type of procedure was incorrect in the previous submissions.This device was being used in a reconstructive skin surgery on the patient¿s right arm.Manufacturer's reference number: (b)(4) procedure type previously reported has been updated in section h10.
Additional Manufacturer Narrative
On (b)(6) 2021, 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
On 28-jul-2021, upon review, it was determined that mentor did not receive specific patient consequence.Since there is no applicable patient consequence code (h.6.Health effect - clinical code), the coding was updated with insufficient information (e2401).The relevant field has been updated.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
On (b)(6) 2021, the investigation on the suspected medical device was completed.Investigation summary: mentor conducted a visual inspection, leak test, and microscopic examination of the returned device.Visual analysis of the returned device revealed a tear (a) on the anterior aspect that was measured approximately 0.4 cm.Leak testing was performed in accordance with mentor procedures, and a tear (b) was observed on the anterior view, measuring approximately 0.5 cm.Microscopic examination was performed on the edges of rupture a, and parallel striations were found in the whole area of the tear.Parallel striations are consistent with markings made by a sharp object perforating the implant shell.In addition, the cause of tear b could not be identified.As part of mentor¿s quality process, all devices are manufactured, inspected, and released to approved specifications.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
• MDR Report Key: 11467817
• Report Number: 1645337-2021-02599
• Device Sequence Number: 3631524
• Product Code: LCJ
• UDI-Device Identifier: 00081317002512
• UDI-Public: 00081317002512
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 02/17/2021

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 Model Number: 3504315M
• Device Catalogue Number: 3504315M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2021
• Initial Date Received by Manufacturer: 02/17/2021
• Supplement Date Received by Manufacturer: 03/17/2021; 04/14/2021; 06/16/2021; 07/15/2021; 07/28/2021
• Initial Report FDA Received Date: 03/11/2021
• Supplement Report FDA Received Date: 04/08/2021; 04/15/2021; 06/17/2021; 07/15/2021; 08/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 24 YR