MAUDE Adverse Event Report: MENTOR TEXAS MENTOR MEMORYSHAPE¿ MM 315CC; PROSTHESIS, BREAST, NONINFLATABLE, INTERNAL, SILICONE GEL-FILLED

Catalog Number	3541258
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Codes	Breast Mass (2439); No Code Available (3191)
Date of Event	08/01/2019
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.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.Concomitant medical products: mentor memoryshape¿ 3175cc , silicone breast implants, ref/sn l cat#: 3541258g sn#: (b)(4), lot#:264215.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a (b)(6) caucasian female patient underwent a primary breast augmentation with mentor memoryshape¿ 3175cc , silicone breast implants which the right side ruptured after implantation.The issue was confirmed by the physician via mri examination.The report also indicated large lump on right side of the breast almost in the armpit, and smaller lumps elsewhere on the breast.Breast slightly swollen, hard and misshapen.As a result patient scheduled for device removal and replacement with another mentor device on (b)(6) 2019.
Additional Manufacturer Narrative
Device evaluation summary: during evaluation of the sample, it was observed to be ruptured.Microscopic examination was performed to the tear and no evidence of instrument damage was observed.No other anomalies were discovered.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.Based on the information reported and/or the product investigation, there is no evidence that the issue is related with the manufacturing process.All the implants are 100% inspected before leaving the facility.There is no evidence that the issue is related with manufacturing 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).
Additional Manufacturer Narrative
On 10/24/2019, additional information received indicated that the patient underwent bilateral removal and replacement as follow: left replaced with catalog number 3341255, serial number (b)(4), and right replaced with catalog number 3341255, serial number (b)(4).On 11/5/2019, 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.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYSHAPE¿ MM 315CC
• 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: 9232692
• Report Number: 1645337-2019-22467
• Device Sequence Number: 11383620
• Product Code: FTR
• UDI-Device Identifier: 00081317005469
• UDI-Public: 00081317005469
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P060028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2003
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/30/2019

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: 07/31/2008
• Device Catalogue Number: 3541258
• Device Lot Number: 264215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2019
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 10/24/2019; 11/20/2019
• Initial Report FDA Received Date: 10/24/2019
• Supplement Report FDA Received Date: 11/15/2019; 11/22/2019
• 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: 42 YR