MAUDE Adverse Event Report: MENTOR TEXAS MENTOR ARTOURA ULTRA HIGH PROFILE; EXPANDER, SKIN, INFLATABLE

Catalog Number 35051135L

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Code Available (3191)

Event Date 05/31/2017

Event Type  Injury  

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 device history record review is in progress.Once completed, a supplemental report will be submitted.Concomitant products: gel mentor artoura ultra high profile tissue expander, catalog number 35051135l, serial number (b)(4), lot number 7294531.Manufacturer¿s reference number: (b)(4).

Event Description

It was reported that a (b)(6) -year-old caucasian female patient who underwent breast reconstruction with mentor smooth uhp 1135cc gel implants on (b)(6) 2017 experienced adverse events.The patient has medical history of hypertension and elevated cholesterol.Prior to reconstruction, the patient was diagnosed in (b)(6) 2016 with stage i left upper medial quadrant ductal breast cancer and in situ right lower medial quadrant ductal breast cancer in (b)(6) 2015.The patient underwent radiation therapy in radiation in (b)(6) 2015, bilateral skin sparing mastectomies on (b)(6) 2016, and chemotherapy from (b)(6) 2016.The patient also had mentor artoura ultra high profile tissue expanders before reconstruction that were explanted on (b)(6) 2017 when placing the gel implants.The patient experienced the following post reconstruction with the mentor smooth uhp 1135cc gel implants.The patient had some postoperative erythema/ inflammation, and swelling of left breast that was resolved by (b)(6) 2017.The principal investigator of this patient assessed these events as unrelated to study device or procedure.The patient then had left breast device migration and malposition and right breast asymmetry that was observed on (b)(6) 2017.On (b)(6) 2017, the patient underwent left breast capsulectomy and pocket adjustment with use of stratus acellular dermal matrix and original device was kept in.On the same day, the patient also underwent right side implant exchange due to breast asymmetry.The device was intact upon removal.The left breast device was malpositioned/ displaced again on (b)(6) 2017 and the patient underwent capsulorrhaphy and implant exchange of the left device on (b)(6) 2017.The device was intact upon removal.This medwatch is for the right breast implant.

Manufacturer Narrative

On 05/15/2018, it was reported to mentor that the device history record (dhr) for the lot number 7317086 has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.Manufacturer¿s reference number: (b)(4).

Manufacturer Narrative

On 08/02/18, it was reported to mentor that the patient experienced necrosis on the left breast implant.Additional information received actually makes the event not-reportable.Manufacturer¿s reference number: (b)(4).

Manufacturer Narrative

On (b)(6) 2019, it was reported to mentor that the patient¿s initials are ss.The patient¿s date of birth was (b)(6) 1958.Manufacturer¿s reference number: (b)(4).

Manufacturer Narrative

On 1/3/19, it was reported to mentor that the patient experienced capsular contracture baker grade iii on the left breast implant.The patient¿s date of birth was (b)(6) 1958 manufacturer¿s reference number: (b)(4).

Manufacturer Narrative

On (b)(6)2019, it was reported to mentor that the facility information was (b)(4).The patient participated in athena study.On (b)(6)2019, it was erroneously omitted to report that the patient experienced dissatisfaction because of asymmetry noted on (b)(6)2017, removed and replaced on (b)(6)2017.Manufacturer¿s reference number: (b)(4).

Manufacturer Narrative

This device has not been approved by us fda and is not marketed in the us.Therefore, this complaint is not mdr reportable.Therefore, this type of event is not covered by post-market spreadsheet report exemption #e2007003 and will be reported under the ide regulations.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR ARTOURA ULTRA HIGH PROFILE
• Type of Device: EXPANDER, SKIN, INFLATABLE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 7462761
• MDR Text Key: 106583252
• Report Number: 1645337-2018-02444
• Device Sequence Number: 1
• Product Code: LCJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/28/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 04/25/2021
• Device Catalogue Number: 35051135L
• Device Lot Number: 7317086
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/25/2018
• Supplement Dates Manufacturer Received: Not provided; Not provided; 01/03/2019; 11/19/2019; 12/11/2019; 08/04/2020
• Supplement Dates FDA Received: 05/15/2018; 08/23/2018; 01/03/2019; 11/27/2019; 12/26/2019; 08/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR