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

Model Number	3542714
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/01/2020
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 (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: n/a.(b)(4).
Event or Problem Description
It was reported that a (b)(6) year-old female who underwent primary breast reconstruction with a mentor siltex contour profile high 550cc saline prosthesis experienced spontaneous right sided deflation post procedure.The deflation was diagnosed by a physical examination.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.
Additional Manufacturer Narrative
The impacted product was received by the failure analysis lab on (b)(6) 2021.The investigation of the returned photograph was completed by the failure analysis lab on (b)(6) 2021.Device evaluation summary: during visual evaluation of the device an area of siltex cracking was observed on the posterior aspect.Additionally, a tear was observed within the siltex cracking measuring approximately 0.5 cm.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.Each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR SILTEX CONTOUR PROFILE HIGH
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 10550403
• Report Number: 1645337-2020-11790
• Device Sequence Number: 3507713
• Product Code: FWM
• UDI-Device Identifier: 00081317001935
• UDI-Public: 00081317001935
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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: 10/31/2008
• Device Model Number: 3542714
• Device Catalogue Number: 3542714
• Device Lot Number: 5559653
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Initial Date Received by Manufacturer: 08/28/2020
• Supplement Date Received by Manufacturer: 01/08/2021
• Initial Report FDA Received Date: 09/17/2020
• Supplement Report FDA Received Date: 01/25/2021
• 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: Required Intervention
• Patient Age: 53 YR