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

Catalog Number	3504310M
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/03/2019
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.Reason for device explant and/or reoperation: deflation of tissue expander.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a male patient underwent an unknown procedure with three mentor tissue expander 550cc devices that all deflated after implantation.These expanders became detached from the back twice.The first expander was placed in the upper left of the patient¿s abdomen, second expander in the lower left of the patient¿s abdomen, and the third expander in the mid right of the patient¿s abdomen.As a result, the patient had all three devices explanted on (b)(6) 2019.There were no replacements for the explanted devices.This medwatch report is for the device placed in the mid right of the patient¿s abdomen.
Additional Manufacturer Narrative
On (b)(6) 2019, mentor received additional information about the event.The date of event is (b)(6) 2019.The patient was 69 years old at the time of event.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: 8565992
• Report Number: 1645337-2019-10785
• Device Sequence Number: 16771883
• Product Code: LCJ
• UDI-Device Identifier: 00081317002468
• UDI-Public: 00081317002468
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2019

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: 03/01/2022
• Device Catalogue Number: 3504310M
• Device Lot Number: 7550998
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/08/2019
• Supplement Date Received by Manufacturer: 05/13/2019
• Initial Report FDA Received Date: 04/30/2019
• Supplement Report FDA Received Date: 06/06/2019
• 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
• Patient Age: 69 YR