MAUDE Adverse Event Report: MENTOR TEXAS MENTOR SILTEX CONTOUR PROFILE MODERATE; PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE

Model Number	3542911
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/18/2019
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.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.Concomitant medical products: 225cc textured mentor siltex contour profile moderate saline breast implant, catalog # 3542911, serial # (b)(4).Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) caucasian female patient who underwent a breast augmentation revision with a 225cc textured mentor siltex contour profile moderate saline breast implant has experienced postoperative right-sided deflation, confirmed by a physician.Hcp reported that the right side has become smaller.As a result, the patient is scheduled to undergo explantation on (b)(6) 2020.
Additional Manufacturer Narrative
On (b)(6)2020, mentor completed the investigation on the suspect medical device.Device evaluation summary: according to the reported information, the patient experienced a rupture in the breast saline implant.During visual inspection of the device no apparent damage could be observed.Leak testing revealed there was leakage from the valve.The analysis was unable to determine the root cause for the leaking valve.Excessive manipulation may have caused the valve leak.The ifu states ¿not to manipulate (i.E., squeeze) the valve excessively, which may cause valve leakage¿.However, this cannot be conclusively determined.The manufacturing records were reviewed, and the manufacturing criteria were met prior to the release of this lot.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.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).
Additional Manufacturer Narrative
On (b)(6) 2020, mentor received additional information that the patient underwent replacement with 325cc mentor smooth round moderate plus profile saline breast implants, catalog # 3502325, left serial # (b)(4) and right serial # (b)(4) on (b)(6) 2020.Upon explantation, the right implant was confirmed to be deflated and had rotated sideways, and the left implant was confirmed to be rotated.This medwatch report is for the right-sided implant.On (b)(6) 2020, 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.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR SILTEX CONTOUR PROFILE MODERATE
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 9645211
• Report Number: 1645337-2020-01581
• Device Sequence Number: 1965053
• Product Code: FWM
• UDI-Device Identifier: 00081317001850
• UDI-Public: 00081317001850
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/08/2020

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: 08/31/2015
• Device Model Number: 3542911
• Device Catalogue Number: 3542911
• Device Lot Number: 6503086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2020
• Initial Date Received by Manufacturer: 01/08/2020
• Supplement Date Received by Manufacturer: 02/06/2020; 03/03/2020
• Initial Report FDA Received Date: 01/29/2020
• Supplement Report FDA Received Date: 03/03/2020; 03/04/2020
• 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: 55 YR