MAUDE Adverse Event Report: MENTOR TEXAS MENTOR MEMORYGEL BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	3507125BC
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Local Reaction (2035); No Code Available (3191)
Date of Event	06/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.Since no lot number was provided, no manufacturing record evaluation review could be performed.However, mentor performs 100% inspection and testing of all devices prior to release and maintains a comprehensive quality assurance system in compliance with the fda's good manufacturing practice regulations.Reason for device explant and/or reoperation: rupture.Concomitant medical products: 125cc mentor smooth round moderate profile gel-filled catalog: 3507125bc lot: unknown serial number: (b)(4).Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) caucasian patient who underwent primary breast augmentation surgery with a 125cc mentor memorygel breast implant experienced right sided rupture post procedure.A magnetic resonance imagery was performed on (b)(6) 2019 which confirmed right sided rupture.Patient also experienced right sided swollenness.As a result, patient had an explantation on (b)(6) 2019.
Additional Manufacturer Narrative
The investigation of the returned device was completed by the failure analysis lab on (b)(6) 2020.Device evaluation summary: according with the information reported the patient experienced a local reaction and a rupture in the breast implant.During evaluation of the device it was observed to be ruptured.Since the authorization for return and examination of medical device form was not signed and/or returned, mentor product analysis lab was precluded from further evaluating the device.No other anomalies were discovered.Causes of rupture of gel-filled implants include but are not limited to the following events: damage from surgical instruments, intraoperative or postoperative trauma, excessive stresses or manipulations as may occur during normal, daily routines including customary and purposeful trauma to the breast.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYGEL BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 9445016
• Report Number: 1645337-2019-25418
• Device Sequence Number: 2219713
• Product Code: FTR
• UDI-Device Identifier: 00081317000020
• UDI-Public: 00081317000020
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2002
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2019

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 Catalogue Number: 3507125BC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2019
• Initial Date Received by Manufacturer: 11/12/2019
• Supplement Date Received by Manufacturer: 01/07/2020
• Initial Report FDA Received Date: 12/10/2019
• Supplement Report FDA Received Date: 01/08/2020
• 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: 35 YR