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

Catalog Number	3504311M
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complaint device has been discarded.As a result, no product failure analysis can be conducted, and device malfunction cannot be confirmed.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 surgeon was using a 700cc mentor tissue expander to remove a congenital naevus from a young female patient's back (whose age was unspecified), and discovered that the device was broken and deflated.Prior to the deflation, the patient's device had been receiving weekly inflations.The physician noted that the deflation occurred on the posterior aspect of the device, and therefore could not have been iatrogenic in nature.The impacted device was explanted from the patient on an unspecified date and replaced with a like device.If the date of the device's explantation becomes known, mentor will submit a follow-up report with the new information.
Additional Manufacturer Narrative
On 10/17/2019, the product investigation was completed.The product was not returned for analysis; however, mentor received a photo of the impacted product.Upon visual inspection of the picture, a rupture was noted between the patch and shell.No other anomalies were observed.The photo do not provide enough evidence to determine root cause.Hands-on analysis should provide the evidence necessary to confirm the root cause.The manufacturing records were reviewed and the manufacturing criteria were met prior to the release of this lot.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: 9089058
• Report Number: 1645337-2019-19165
• Device Sequence Number: 2297897
• Product Code: LCJ
• UDI-Device Identifier: 00081317002475
• UDI-Public: 00081317002475
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2019

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 Expiration Date: 10/18/2020
• Device Catalogue Number: 3504311M
• Device Lot Number: 7387526
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/21/2019
• Supplement Date Received by Manufacturer: 08/21/2019
• Initial Report FDA Received Date: 09/19/2019
• Supplement Report FDA Received Date: 10/21/2019
• 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