MAUDE Adverse Event Report: MENTOR TEXAS MENTOR MEMORYGEL BREAST IMPLANT; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	3544057MC
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.The manufacturing record evaluation (mre) was performed, and no anomalies were found related to this complaint.In addition, the mre review verifies that the device was manufactured in accordance with documented specification and procedures.Reason for device explant and/or reoperation: rupture concomitant medical products: gel mentor memorygel breast implant 405cc, catalog number 3544057mc, serial number (b)(4), lot 6566250.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) caucasian female patient underwent a breast augmentation revision with a gel mentor memorygel breast implant 405cc and experienced left side rupture noticed during revision surgery.As a result, the patient had undergone removal and replacement with on (b)(6) 2019.The patient has a history of hypomastia.
Additional Manufacturer Narrative
On 5/3/19, it was reported to mentor that the replacement devices were gel mentor memorygel breast implant 450cc.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
On 6/4/2019, during analysis of the sample a parallel lines of shell wear were observed on the anterior aspect, suggesting in-vivo folding or creasing of the device and siltex cracking was observed in the posterior view.Leak testing was performed, and it revealed a tear within siltex cracking, measuring approximately 0.3 cm.No additional anomalies were observed.The second product received is related to a concomitant device, therefore no further investigation is required.The manufacturing records were reviewed and the manufacturing criteria were met prior to the release of this lot.Rupture, as indicated in the product insert data sheet (pids), is a known complication associated with mentor mammary prostheses.Causes of rupture of gel-filled implants include, but are not limited to the following events: damage from surgical instruments, intraoperative or postoperative trauma, excessive stresses or manipulations as may occur during normal, daily routines including customary and purposeful trauma to the breast.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 htv ( high temperature vulcanization) shell of siltex breast implants.The reported complaint was confirmed.Rupture 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.Complaint information will be included in complaint trending that is reviewed and monitor by quality assurance on a regular basis to determine if further action is necessary.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYGEL BREAST IMPLANT
• Common Device Name: PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED
• Manufacturer (Section D): MENTOR TEXAS; 3041 skyway circle north; irving TX 75038
• MDR Report Key: 8577546
• Report Number: 1645337-2019-11028
• Device Sequence Number: 13912548
• Product Code: FTR
• UDI-Device Identifier: 00081317004448
• UDI-Public: 00081317004448
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• 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): 04/12/2019

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: 03/31/2017
• Device Catalogue Number: 3544057MC
• Device Lot Number: 6566250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2019
• Initial Date Received by Manufacturer: 05/03/2019
• Supplement Date Received by Manufacturer: 05/03/2019; 06/04/2019
• Initial Report FDA Received Date: 05/03/2019
• Supplement Report FDA Received Date: 05/03/2019; 06/05/2019
• 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: 50 YR