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

Catalog Number	UNK_GEL IMPLANTS
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/25/2018
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.Reason for device explant and/or reoperation: deflation.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) female patient who underwent primary breast augmentation with a 550cc mentor cpx 4 breast tissue expander on the right side, suffered rupture post-operatively.As a result, the patient underwent removal and replacement with an unknown device on (b)(6) 2018.
Additional Manufacturer Narrative
On 7/15/2019, additional information was received.Per product investigation diagram of the returned device, mentor became aware that the device was an unspecified mentor gel implant.No lot number was provided.On 7/22/2019, the product investigation was completed.Device investigation summary: during analysis of the sample a rupture was observed on the anterior view, measurement approximately 4 cm.Additional testing was not performed to avoid compromise the device integrity.No other anomalies were observed.Since the authorization for return and examination of medical device form was not signed and/or returned to mentor, mentor product analysis lab was precluded from further evaluating the device.Rupture, as indicated in the product insert data sheet (pids), is a known complication associated with mentor mammary prostheses.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.It should be noted that as part of our quality process, each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.Based on the information reported and/or the product investigation, there is no evidence that the issue is related with the manufacturing process.Manufacturer¿s reference number: (b)(4).

• Brand Name: UNKNOWN GEL IMPLANTS
• 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: 8661243
• Report Number: 1645337-2019-13060
• Device Sequence Number: 13534947
• Product Code: FTR
• UDI-Device Identifier: 00081317006497
• UDI-Public: 00081317006497
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2019

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: UNK_GEL IMPLANTS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2019
• Initial Date Received by Manufacturer: 05/03/2019
• Supplement Date Received by Manufacturer: 07/15/2019
• Initial Report FDA Received Date: 06/01/2019
• 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: 58 YR