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

Catalog Number	3542610
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).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 device history record review is in progress.Once completed, a supplemental report will be submitted.(b)(4).
Event or Problem Description
It was reported that a (b)(6) year old female patient underwent breast augmentation revision with mentor siltex round moderate profile 125cc breast prostheses.Deflation on the right breast prosthesis was diagnosed by ultrasonography.As a result, the patient underwent removal and replacement with mentor memorygel breast implant 150cc gel breast prosthesis on (b)(6) 2018.
Additional Manufacturer Narrative
On (b)(6) 2018, 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.Mentor also became aware that the patient also experienced deflation on the concomitant medical product: mentor siltex round moderate profile 125cc saline, catalog #3542610, lot #230331.(b)(4).
Additional Manufacturer Narrative
On 6/12/2018, the device history record (dhr) was reviewed, and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.(b)(4).
Additional Manufacturer Narrative
Upon receipt by mentor, the device contained no fluid.No foreign material was observed within the device.Brown material was observed on the shell surface.During visual examination of the device, product evaluation observed a rent on the anterior view measuring 1.2 cm.Microscopic examination of the rent edges revealed parallel striations which are similar to markings made by a sharp instrument perforating silicone material.No other anomalies were found.Mentor performs 100% inspection and testing of all devices prior to release; product evaluation concluded that the rent occurred sometime subsequent to the removal of the device from its protective packaging.The complaint of deflation was confirmed since a rent was found on the device.Microscopic examination revealed parallel striations on the edges of the rent.This type of striations is more conclusive to sharp instrument damage rather than shell failure due to wear.At this point is it not possible to determine the origin of the brown material observed.Mentor performs 100% inspection and testing of all devices prior to release; product evaluation concluded that the rents occurred sometime subsequent to the removal of the device from its protective packaging.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.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR SILTEX ROUND MODERATE PROFILE
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 7489007
• Report Number: 1645337-2018-02670
• Device Sequence Number: 1950062
• Product Code: FWM
• UDI-Device Identifier: 00081317001713
• UDI-Public: 00081317001713
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2002
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/09/2018

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: 08/31/2005
• Device Catalogue Number: 3542610
• Device Lot Number: 230331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2018
• Initial Date Received by Manufacturer: 04/09/2018
• Supplement Date Received by Manufacturer: 04/09/2018; 04/09/2018; 08/09/2018
• Initial Report FDA Received Date: 05/04/2018
• Supplement Report FDA Received Date: 06/14/2018; 08/01/2018; 08/10/2018
• 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: 48 YR