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

Catalog Number	3542615
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the time of this report, mentor has received no information regarding explantation or an expected explantation date.It is unknown at this time if the device will be made available for return.As a result, 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.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).
Event or Problem Description
It was reported that a (b)(6) -year-old female patient underwent a breast augmentation revision with a saline mentor siltex round moderate profile 150cc and experienced deflation on the left side post-operatively.Deflation was confirmed by physician.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.
Additional Manufacturer Narrative
Device evaluation summary: upon receipt by mentor, the device contained no fluid.No foreign material was observed within the device or on the shell surface.During visual examination of the device, mentor product analysis lab observed a rent on the posterior view measuring approximately 0.5 cm.Microscopic examination of the rent edges gave no indication as to its cause.No other anomalies were found.Mentor products are 100% visually inspected prior to release in addition to thorough in-process testing during several stages of the manufacturing process.Mentor product analysis lab 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.Nonetheless, a microscopic examination of the rent edges was performed, and it did not provide conclusive evidence of what could be the root cause.There is no evidence that the issue is related with manufacturing.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).
Additional Manufacturer Narrative
The following information was mistakenly omitted from the report submitted on 10/5/2018: information received indicated patient race is caucasian and that the patient will undergo removal of the breast prosthesis on (b)(6) 2018.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 11/17/2018, the mentor failure analysis lab 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.Additional information received on 11/19/2018 indicated the patient underwent bilateral removal and replacement with saline mentor smooth round moderate profile 150cc filled to 175cc, catalog number 3501615, lot number 7556439, serial number (b)(4).The concomitant product was identified as a saline mentor siltex round moderate profile 150cc, catalog number 3542615, serial number (b)(4), lot number 6972092.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: 7940155
• Report Number: 1645337-2018-05947
• Device Sequence Number: 1914105
• Product Code: FWM
• UDI-Device Identifier: 00081317001720
• UDI-Public: 00081317001720
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/12/2018

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: 09/06/2019
• Device Catalogue Number: 3542615
• Device Lot Number: 6972092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2018
• Initial Date Received by Manufacturer: 09/12/2018
• Supplement Date Received by Manufacturer: 10/04/2018; 11/17/2018; 12/09/2018
• Initial Report FDA Received Date: 10/05/2018
• Supplement Report FDA Received Date: 11/02/2018; 12/06/2018; 12/31/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 65 YR