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

Catalog Number	3542420M
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/15/2018
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 manufacturing record evaluation (mre) was reviewed, 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).
Event or Problem Description
It was reported that a (b)(6) female patient who underwent primary breast augmentation with a 175cc mentor siltex round spectrum saline breast prosthesis, experienced left side deflation post-operatively.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.
Additional Manufacturer Narrative
On 2/12/2019, mentor became aware that the patient was caucasian.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 6/28/2019, mentor became aware that the correct date of event was (b)(6) 2018.Mentor also became aware that the correct date of explantation was (b)(6) 2019.Per the new date of event, the patient's age at the time of event was updated to 28.Mentor also became aware that the patient underwent bilateral removal and replacement with the following devices: (left) 325cc mentor smooth round moderate plus profile saline catalog: 3502325 lot: 7688116 sn: (b)(4) and (right) 175cc mentor smooth round moderate profile saline catalog: 3501620 lot: 7643260 sn: (b)(4).Mentor also became aware that the patient also experienced asymmetry on the contralateral breast (right side).It was reported under: 1645337-2019-15102.On 7/9/2019, the product investigation was completed.Device investigation summary: during the evaluation of the sample, it was noticed that two lines of shell wear were observed on the anterior aspect, suggesting in-vivo folding or creasing of the device.In addition a rupture in the anterior aspect was observed measuring 0.9 cm within the shell wear.No additional anomalies were observed.These kind of findings are consistent with a shell wear failure which is a known inherent risk associated with the use of saline-filled mammary prostheses and may be the result of one or more of the following contributing factors: under-inflation or over-inflation of the device, continuous and sustained stresses to the device - such as capsular contracture or too small a breast pocket and folding or wrinkling of the shell in the breast pocket.The manufacturing records were reviewed and the manufacturing criteria were met prior to the release of this lot.No conclusion could be reached as to what may have caused the reported incident.The reported complaint was confirmed.This report is not intended to deny that you experienced a problem with the device.There may have been other circumstances or issues that occurred during the use of the device that we were unable to duplicate during our laboratory analysis.This medwatch form is for the left breast prosthesis.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
On 5/17/2019, the mentor failure analysis lab has 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.Mentor also became aware that the patient underwent implant explantation on (b)(6) 2019.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 10/28/2019, mentor became aware that previously submitted medwatches under manufacture report number (b)(4) were duplicated.Any additional event information received will be submitted under this manufacturer¿s report number.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: 8400300
• Report Number: 1645337-2019-09064
• Device Sequence Number: 2326634
• Product Code: FWM
• UDI-Device Identifier: 00081317002062
• UDI-Public: 00081317002062
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 02/08/2019

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: 07/31/2018
• Device Catalogue Number: 3542420M
• Device Lot Number: 6847819
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2019
• Initial Date Received by Manufacturer: 02/08/2019
• Supplement Date Received by Manufacturer: 02/12/2019; 05/17/2019; 06/28/2019; 10/28/2019
• Initial Report FDA Received Date: 03/07/2019
• Supplement Report FDA Received Date: 03/11/2019; 06/14/2019; 07/09/2019; 11/26/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 29 YR