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	08/01/2020
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.A manufacturing record evaluation is in progress.Once completed, a supplemental report will be submitted.Reason for device explant and/or reoperation:n/a.(b)(4).Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a caucasian female patient underwent a primary breast augmentation with a 250cc mentor siltex contour profile moderate prosthesis and experienced postoperative deflation (side unknown).A healthcare professional states that the patient is possibly experiencing unilateral deflation.At the time of this report, mentor has received no information regarding an expected explantation date.
Additional Manufacturer Narrative
On 6-oct-2020, mentor received additional information regarding the patient¿s demographics and implant location.The patient¿s initials are (b)(6).The patient¿s date of birth is (b)(6) 1973.The patient experienced right-sided deflation.The relevant fields have been updated.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
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.The relevant fields have been updated.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
On (b)(6) 2021, mentor received additional information regarding the revision surgery and suspected medical device.The patient underwent removal and replacement with two 250cc mentor memorygel breast implant prostheses (catalog #: 3502501bc, left serial#: (b)(6), right serial #: (b)(6)) on (b)(6) 2020.Updated reason for device explant and/or reoperation: deflation the suspected medical device was returned for evaluation.On 25-jan-2021, the investigation on the suspected medical device was completed.Investigation summary: visual analysis of the returned device revealed an area of siltex cracking on the posterior view.Additionally, a tear was observed within the siltex cracking, measuring approximately 0.5 cm.The evaluation determined that the cause of the deflation is consistent with normal wear.Siltex cracking is defined as a material separation occurring in the siltex layer and can eventually progress through the shell of siltex devices.Siltex cracking is ultimately a result of high stresses.It should be noted that as part of mentor¿s quality process all devices are manufactured, inspected, and released to approved specifications.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: 10555438
• Report Number: 1645337-2020-11848
• Device Sequence Number: 16815055
• Product Code: FWM
• UDI-Device Identifier: 00081317001850
• UDI-Public: 00081317001850
• 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: 1999
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/02/2020

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: 02/28/2003
• Device Model Number: 3542911
• Device Catalogue Number: 3542911
• Device Lot Number: 189503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2021
• Initial Date Received by Manufacturer: 09/02/2020
• Supplement Date Received by Manufacturer: 09/29/2020; 10/06/2020; 01/20/2021
• Initial Report FDA Received Date: 09/18/2020
• Supplement Report FDA Received Date: 10/01/2020; 10/09/2020; 01/26/2021
• 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: Other; Required Intervention
• Patient Age: 47 YR