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	02/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since the device has not been returned for analysis, 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 device history record (dhr) was reviewed, and no anomalies were found related to this complaint.In addition, the dhr review 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) -year-old caucasian female patient underwent a breast reconstruction revision procedure with a saline mentor siltex round spectrum 275cc breast implant and experienced deflation on the left breast implant.At the time of this report, mentor has received no information regarding explantation or an expected explantation date.
Additional Manufacturer Narrative
On (b)(6) 2018, it was reported to mentor that the patient will undergo explantation on (b)(6) 2018.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 05/16/18, it was reported to mentor that the patient will undergo explantation on (b)(6) 2018.On 05/23/18, it was reported to mentor that there was no new development of cancer.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 06/22/18, it was reported to mentor that 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.In addition, the explantation date was (b)(6) 2018.The replacement device was saline mentor siltex round spectrum 275cc, catalog number 3542440m, lot number 7384676, serial number (b)(4).Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 06/27/18, it was reported to mentor that the date problem observed was reported incorrectly in the previous report.The actual date of problem observed was (b)(6) 2018.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 09/03/18, it was reported to mentor that the device evaluation and investigation have been completed.Upon receipt by mentor, the device returned with clear fluid.Brown material was observed within the device.No foreign material was observed on the shell surface.Product evaluation team discovered a rent measuring approximately 0.4 cm within an area of siltex cracking on the posterior aspect.Also was noticed lines of shell wear on the anterior aspect, suggesting in-vivo folding or creasing of the device.No other anomalies were discovered.Potential cause: the complaint was confirmed since a rupture was found on the device.However, at this point it is not possible to determine the root cause of such damage or the etiology of the brown material found on the device.There is no evidence that the issue is related with manufacturing.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 rtv shell of siltex breast implants.The severity level for this complaint code was determined to be a s3, which is defined as: necessitates intrusive medical or surgical intervention.Because pe was unable to confirm any unusual failure mode, no corrective action will be taken at this time.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.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: 7451591
• Report Number: 1645337-2018-02285
• Device Sequence Number: 16171469
• Product Code: FWM
• UDI-Device Identifier: 00081317002086
• UDI-Public: 00081317002086
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P990075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 03/27/2018

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: 05/31/2013
• Device Catalogue Number: 3542440M
• Device Lot Number: 5908004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2018
• Initial Date Received by Manufacturer: 03/27/2018
• Supplement Date Received by Manufacturer: 03/27/2018; 03/27/2018; 03/27/2018; 03/27/2018; 03/27/2018
• Initial Report FDA Received Date: 04/23/2018
• Supplement Report FDA Received Date: 05/23/2018; 05/23/2018; 06/29/2018; 07/12/2018; 09/03/2018
• 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
• Patient Age: 61 YR