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

Catalog Number	3542440M
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/01/2018
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.Since no lot number was provided, no device history record (dhr) review could be performed.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) female underwent primary breast augmentation with a 275cc mentor siltex round spectrum saline prosthesis and experienced right sided deflation post procedure.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.
Additional Manufacturer Narrative
Additional information was received on (b)(6) 2019.The lot number has been provided and d7 has been updated.The device was explanted on (b)(6) 2019.A device history record review is in progress.Once completed, a supplemental report will be submitted.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
The investigation of the returned device was completed by the failure analysis lab on 6/15/2019.A manufacturing record evaluation (mre) was performed for the finished device number (b)(4), and no non-conformances related to the reported complaint were identified.Device evaluation summary: according to the information provided, it was reported that the patient experienced a deflation of the implant.During the evaluation of the sample, five (5) lines of shell wear were observed on the anterior aspect, suggesting in-vivo folding or creasing of the device.In addition during the leak testing a rupture measuring 0.4 cm was observed.Siltex cracking on the posterior aspect of the implant was noted.No other anomalies were observed.The second product received is a concomitant device, no further information is required.Siltex cracking is defined as a material separation occurring in the siltex layer and can eventually progress through the shell of siltex devices.Mentor believes that siltex cracking is ultimately a result of high stresses caused by acute folds (i.E., severe ¿v¿ or tight folds) in the room temperature vulcanization (rtv) shell of siltex breast implants.The reported complaint was confirmed.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.It should be noted that as part of our quality process, each device is visually inspected and functionally tested during manufacturing to ensure the device meets the required specifications prior to shipment.Based on the information reported and/or the product investigation, there is no evidence that the issue is related with the manufacturing process.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR SILTEX ROUND SPECTRUM
• Common Device Name: PROSTHESIS, BREAST, INFLATABLE, INTERNAL, SALINE
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 8426703
• Report Number: 1645337-2019-09373
• Device Sequence Number: 2242188
• Product Code: FWM
• UDI-Device Identifier: 00081317002086
• UDI-Public: 00081317002086
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1994
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/20/2019

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: 10/31/1998
• Device Catalogue Number: 3542440M
• Device Lot Number: 86199
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2019
• Initial Date Received by Manufacturer: 02/20/2019
• Supplement Date Received by Manufacturer: 03/19/2019; 05/20/2019
• Initial Report FDA Received Date: 03/16/2019
• Supplement Report FDA Received Date: 04/15/2019; 06/19/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 55 YR