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

Model Number	3505305M
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/26/2019
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.(b)(6).Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that prior to implantation, a mentor tissue expander 250cc was found to be deflated while in preparation.No delays in surgery were reported.The patient underwent implantation with a mentor tissue expander 250cc, serial number (b)(4) as a replacement.
Additional Manufacturer Narrative
Device evaluation summary: the device was visually inspected and it was found with no apparent damage.Leak testing revealed a tear noted in the posterior aspect measuring approximately 0.2 cm.Microscopic examination of the edges of the rupture revealed parallel striations.The striations are consistent with markings made by a sharp instrument perforating silicone material.As stated in the product insert data sheet, do not allow cautery devices or sharp instruments, such as scalpels, suture needles, hypodermic needles, hemostats, adson forceps or scissors to contact the device during surgical procedures as this can result in rupture.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
On (b)(6) 2019, it was noticed that type of reportable event was erroneously entered a serious injury.This event is a malfunction and the field has been updated.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 1/28/2020, the mentor failure analysis lab received and processed 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).

• 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: 8941830
• Report Number: 1645337-2019-18066
• Device Sequence Number: 19447538
• Product Code: LCJ
• UDI-Device Identifier: 00081317002581
• UDI-Public: 00081317002581
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K842883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/20/2020
• Device Model Number: 3505305M
• Device Catalogue Number: 3505305M
• Device Lot Number: 7374215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2020
• Initial Date Received by Manufacturer: 07/30/2019
• Supplement Date Received by Manufacturer: 10/02/2019; 01/28/2020; 02/21/2020
• Initial Report FDA Received Date: 08/28/2019
• Supplement Report FDA Received Date: 10/02/2019; 02/19/2020; 02/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1