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

Model Number	3547213
Medical Device Problem Codes	Off-Label Use (1494); Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/27/2020
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.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) year old caucasian female patient underwent a breast augmentation procedure with a mentor cpx 3 breast tissue expander with suturing tabs 450cc device that deflated after implantation.Deflation of the patient¿s left tissue expander was reported.The device was implanted in the patient for longer than 6 months, which is against the ifu.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.
Additional Manufacturer Narrative
On 17-apr-2020, 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.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 13-jul-2020, mentor received additional information about the event: - the initial information received about the identity of the suspect medical device is incorrect.It was initially reported to mentor that the suspect medical device is a mentor cpx 3 breast tissue expander with suturing tabs device, catalog #3547213, lot #6593393, udi #(b)(4), 510(k) #k011500.New information received states that the suspect medical device is a mentor siltex round moderate profile 375cc saline breast prosthesis, catalog #3542660, lot #6593398, serial #(b)(6), udi #(b)(4), pma #p990075.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.- device code 1494 ¿off-label use¿ no longer applies to this event.Unlike tissue expanders, saline breast prostheses can be implanted in patients for longer than six months.On 30-jul-2020, mentor received additional information about the event: - the patient underwent bilateral explantation and replacement with mentor smooth round moderate plus profile 325cc saline breast prostheses on (b)(6) 2020.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: 9900500
• Report Number: 1645337-2020-05006
• Device Sequence Number: 13659218
• Product Code: FWM
• UDI-Device Identifier: 00081317003687
• UDI-Public: 00081317003687
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• 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): 03/06/2020

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: 05/31/2016
• Device Model Number: 3547213
• Device Catalogue Number: 3542660
• Device Lot Number: 6593398
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/06/2020
• Supplement Date Received by Manufacturer: 04/17/2020; 07/13/2020
• Initial Report FDA Received Date: 03/30/2020
• Supplement Report FDA Received Date: 04/20/2020; 07/30/2020
• 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: Other; Required Intervention
• Patient Age: 60 YR