MAUDE Adverse Event Report: MENTOR TEXAS MENTOR SMOOTH ROUND SPECTRUM; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Catalog Number	3501410
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Not Applicable (3189); No Code Available (3191)
Date of Event	03/15/2019
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.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 right breast prosthesis.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old female patient was undergoing a mentor smooth round spectrum 125cc primary breast augmentation procedure with a saline breast prosthesis that deflated intraoperatively.The surgeon placed the device in the right breast cavity and began to fill it with saline when it was noticed that the valve was leaking.As a result, the device was explanted from the patient.
Additional Manufacturer Narrative
On 05/29/2019, mentor received additional information about the event.The intraoperative deflation of the suspect medical device led to an approximately 1.5-2 hour delay in procedure time.The deflated device was explanted and replaced with new unspecified breast prostheses.On 06/06/2019, mentor completed the investigation on the suspect medical device.Device evaluation summary: according to the information provided, it was reported that the patient experienced a deflation and surgery prolonged on the implant.During evaluation of the sample it appeared intact.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 additional anomalies were discovered the manufacturing records were reviewed, and the manufacturing criteria were met prior to the release of this lot.Deflation is a known complication associated with mentor mammary prostheses.Possible causes of deflation of saline-filled implants include, but are not limited to the following events: excessive stresses or manipulations as may occur during normal, daily routines including customary and purposeful trauma to the breast.The reported complaint was not confirmed.Breast implants are not considered lifetime devices and deflation is a known complication associated with these devices and is referenced in our product insert data sheet.It should be noted that as part of our quality process, each device is visually inspected and functionally tested 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.Complaint information will be included in complaint trending that is reviewed and monitor by quality assurance on a regular basis to determine if further action is necessary.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR SMOOTH ROUND SPECTRUM
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 8563101
• Report Number: 1645337-2019-10765
• Device Sequence Number: 16603322
• Product Code: FWM
• UDI-Device Identifier: 00081317001959
• UDI-Public: 00081317001959
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• 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: 02/25/2020
• Device Catalogue Number: 3501410
• Device Lot Number: 7294539
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2019
• Initial Date Received by Manufacturer: 04/08/2019
• Supplement Date Received by Manufacturer: 05/29/2019
• Initial Report FDA Received Date: 04/29/2019
• Supplement Report FDA Received Date: 06/07/2019
• 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: 26 YR