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

Catalog Number	3541757
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On 9/6/2019, the mentor failure analysis lab has received the device for evaluation.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: rupture.On 9/17/2019, during analysis of the sample was found rupture and received incomplete in two parts.Siltex cracking was found in the edges of the tear.No other anomalies were discovered.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 in shell of siltex breast implants.The manufacturing records were reviewed and the manufacturing criteria were met prior to the release of this lot.No further investigation will be conducted on this complaint as there are no indication that the issue found is related to the manufacturing process.It is most likely that the siltex cracking was created due of high stresses caused by acute folds which resulting in a tear at a later date.Complaint information will be included in complaint trending that is reviewed and monitor by monitored by quality assurance on a regular basis to determine if further action is necessary.Manufacturer¿s reference number: pc-000520527.
Event or Problem Description
It was reported that a hispanic female patient underwent a breast augmentation primary with a mentor memorygel breast implant 175cc and experienced bilateral rupture.As a result, the patient had undergone removal without replacement on (b)(6) 2019.This medwatch is for the right breast implant.

• 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: 9226066
• Report Number: 1645337-2019-21495
• Device Sequence Number: 13936871
• Product Code: FTR
• UDI-Device Identifier: 00081317000624
• UDI-Public: 00081317000624
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P030053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1993
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/06/2019

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: 04/30/1998
• Device Catalogue Number: 3541757
• Device Lot Number: 78638
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2019
• Initial Report FDA Received Date: 10/23/2019
• 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