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

Catalog Number	3341254
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	No Code Available (3191); Cancer (3262)
Date of Event	10/17/2019
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.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: right breast prosthesis rupture, sarcoma.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) female patient underwent a breast augmentation procedure with a mentor memoryshape breast implant 485cc gel breast prosthesis that ruptured after implantation.Rupture of the patient¿s right breast prosthesis was diagnosed by a healthcare professional.In addition, the patient has developed sarcoma.As a result, the patient underwent explantation on (b)(6) 2019.
Additional Manufacturer Narrative
On 12/10/2019, mentor completed the investigation on the suspect medical device.Device evaluation summary: according to the information reported, the patient experienced a rupture in the breast implant and sarcoma.During visual inspection of the device, it was observed with no apparent damage leak testing was performed in accordance with mentor procedures and no leak sites were detected.No additional anomalies were observed.The manufacturing records were reviewed and the manufacturing criteria were met prior to the release of this lot.It should be noted that as part of our quality process, each device is visually inspected during manufacturing to ensure the device meets the required specifications prior to shipment.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 MEMORYSHAPE 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: 9331655
• Report Number: 1645337-2019-23978
• Device Sequence Number: 2498115
• Product Code: FTR
• UDI-Device Identifier: 00081317024231
• UDI-Public: 00081317024231
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2019

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: 04/15/2023
• Device Catalogue Number: 3341254
• Device Lot Number: 7563365
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2019
• Initial Date Received by Manufacturer: 10/17/2019
• Supplement Date Received by Manufacturer: 12/10/2019
• Initial Report FDA Received Date: 11/15/2019
• Supplement Report FDA Received Date: 12/10/2019
• 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: Life Threatening; Required Intervention
• Patient Age: 68 YR