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

Catalog Number	3547007
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/18/2019
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.Since no lot number was provided, no manufacturing record evaluation could be performed.Reason for device explant and/or reoperation: bilateral rupture and left side seroma.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) caucasian female patient who underwent breast implant surgery procedure with mentor medical devices (gel siltex mod-rnd 700cc date of implant (b)(6) 2002) noted the swelling in the left breast in early may with an increase approximately 5 days prior to her physician office visit (b)(6) 2019.The left breast was massively swollen by her surgery (b)(6) 2019.750cc plus of seroma was evacuated from the breast during surgery.The fluid was sent for cytology and a biopsy of the capsule was also sent.These were both negative for alcl.Issue was diagnosed at an office visit on (b)(6) 2019.Surgery was performed on (b)(6) 2019.The procedure was evacuation left breast seroma, bilateral removal ruptured gel implants, and bilateral implant exchange.Replacement devices used were catalog # 3507004bc, sn (b)(4) for the right side and catalog # 3507004bc, sn (b)(4) was used for the left side.This report is for the patient¿s right-sided device.
Additional Manufacturer Narrative
Photo evaluation was completed on 7/22/2019.Upon visual inspection of the picture, it was observed to be ruptured.The photos do not provide enough evidence to determine root cause.Hands on analysis should provide the evidence necessary to confirm the root cause.Mentor products are 100% visually inspected prior to release in addition to thorough in-process testing during several stages of the manufacturing process, complaint trends for mentor devices will continue to be monitored by quality assurance.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: 8709553
• Report Number: 1645337-2019-14062
• Device Sequence Number: 1993008
• Product Code: FTR
• UDI-Device Identifier: 00081317000761
• UDI-Public: 00081317000761
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 05/23/2019

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: 3547007
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/23/2019
• Supplement Date Received by Manufacturer: 07/22/2019
• Initial Report FDA Received Date: 06/18/2019
• Supplement Report FDA Received Date: 07/23/2019
• 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: 55 YR